Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Study Details
Study Description
Brief Summary
This phase II trial is studying the side effects of giving azacitidine together with gemtuzumab ozogamicin to see how well it works in treating older patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving azacitidine together with gemtuzumab ozogamicin may kill more cancer cells.
Detailed Description
PRIMARY OBJECTIVES:
-
To test whether outcomes of patients of age 60 or older with previously untreated non-M3 acute myeloid leukemia treated with azacitidine plus gemtuzumab ozogamicin are sufficient to warrant phase III investigation.
-
To estimate the frequency and severity of toxicities of this regimen in the good- and poor-risk groups of patients.
-
To investigate in a preliminary manner the disease-free survival of patients who achieve complete remission and receive post-remission therapy on this study.
-
To investigate in a preliminary manner the cytogenetic response rates of patients treated with this regimen.
-
To investigate in a preliminary manner the effects of cytogenetic abnormalities, promoter and global methylation changes, and multidrug resistance on overall survival and response to azacitidine plus gemtuzumab ozogamicin therapy.
OUTLINE: Patients are stratified according to risk status (good [60-69 years of age OR Zubrod performance status [PS] 0-1] vs poor [>= 70 years of age AND Zubrod PS 2-3]).
REMISSION INDUCTION THERAPY: Patients receive azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily (QD) on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Patients with residual leukemia (blast count >= 5%) receive a second course of induction therapy beginning between days 15-29. Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.
CONSOLIDATION THERAPY: Patients receive one course of azacitidine and gemtuzumab ozogamicin as in induction therapy (with azacitidine given SC only).
MAINTENANCE THERAPY: Patients receive azacitidine SC on days 1-7. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsies for cytogenetic studies at baseline, remission, and relapse or progression (and at completion of treatment if it does not correspond to one of these time points). Marrow and blood samples are submitted to correlatives studies and submitted to Southwest Oncology Group (SWOG) acute lymphoblastic leukemia (ALL)/chronic lymphocytic leukemia (CLL)/chronic myelogenous leukemia (CML) Repository in Seattle, WA.
After completion of study therapy, patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Treatment (azacitidine, gemtuzumab) See Detailed Description |
Drug: Azacitidine
Given IV or SC during induction; given SC during consolidation and maintenance
Other Names:
Drug: Gemtuzumab Ozogamicin
Given IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Complete Response [Up to 60 days]
Morphologic complete remission (CR): ANC >=1,000/mcL, platelet count >=100,000/mcL, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcL and/or platelet count <100,000/mcL.
- 30-Day Survival [30 days]
Patients surviving more than 30 days after study registration
Secondary Outcome Measures
- Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug [Up to 5 years]
Only adverse events that are possibly, probably or definitely related to study drug are reported.
- Relapse-free Survival [Up to 5 years]
Relapse-free survival (RFS) is defined for all patients who achieve CR or CRi. RFS is measured from the date CR or CRi is first achieved until relapse or death form any cause, with observation censored on the date of last contact for patients last known to be alive without report of relapse. Relapse from CR/CRi is defined as reappearance of leukemic blasts in the peripheral blood; or > 5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Morphologically confirmed diagnosis of acute myeloid leukemia (AML) with classification other than WHO acute promyelocytic leukemia (FAB M3), based on bone marrow examination performed within 14 days prior to registration; patients with World Health Organization (WHO) acute promyelocytic leukemia (FAB M3) or blastic transformation of chronic myelogenous leukemia are not eligible
-
Zubrod performance status 0-3
-
No known hypersensitivity to azacitidine, mannitol, hydroxyurea, orgemtuzumab ozogamicin
-
No prior systemic chemotherapy for acute leukemia with the exception of hydroxyurea; administration of hydroxyurea to control high white blood cell (WBC) count prior to registration is permitted
-
Patients with a history of prior myelodysplastic syndrome (MDS) are eligible according to the following criteria:
-
No prior treatment of MDS with AML induction-type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support
-
Prior cytarabine allowed if dose < 100 mg/m^2/day
-
Prior hematopoietic growth factors, thalidomide, lenalidomide, arsenic trioxide, and signal transduction inhibitors for treatment of MDS allowed
-
No prior treatment with azacitidine, decitabine, or gemtuzumab ozogamicin
-
At least 30 days since prior therapy for MDS and recovered
-
Bilirubin =< 2.0 x institutional upper limit of normal (IULN) within 14 days to registration, unless the elevation is believed to be due to hepatic infiltration by AML
-
Hyperbilirubinemia due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert syndrome or hemolysis is allowed
-
Serum glutamic oxaloacetic transaminase (SGOT) aspartate aminotransferase (AST) =< 2 x IULN, or serum glutamic pyruvate transaminase (SGPT) alanine aminotransferase (ALT) =< 2.0 x IULN , unless the elevation is believed to be due to hepatic infiltration by AML
-
Serum creatinine =< 1.5 x IULN
-
Left ventricle ejection fraction (LVEF) >= 40% by multi-gated acquisition scan (MUGA) or echocardiogram (ECHO) AND no clinical evidence of congestive heart failure within the past 56 days
-
Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 14 days prior to registration to S0703; specimens must be submitted to the site's preferred cytogenetics laboratory
-
Patients must consent to submit specimens to the Southwest Oncology Group (SWOG) acute lymphoblastic leukemia (ALL)/chronic lymphocytic leukemia (CLL)/chronic myelogenous leukemia (CML) repository for cellular and molecular studies; collection of pretreatment blood and/or marrow specimens must be completed within 14 days prior to registration; if a marrow specimen is available, either from the diagnostic marrow or a repeat pre-registration marrow, then it must be submitted along with a peripheral blood specimen; otherwise peripheral blood alone must be submitted; residual specimens will only be banked if the patient provides separate consent; sites are required to offer patients the opportunity to participate in banking
-
No central nervous system (CNS) involvement; if central nervous involvement is clinically suspected, it must be ruled out by a lumbar puncture
-
Women of reproductive potential must have a pregnancy test within 28 days prior to registration; patients must not be pregnant or nursing because of the teratogenic potential of the drugs used in this study; women/men of reproductive potential must have agreed to use an effective contraceptive method
-
Patients not known to be human immunodeficiency virus positive (HIV+) must be tested for HIV infection within 14 days prior to registration
-
HIV-positive patients must meet the following criteria:
-
No history of acquired immunodeficiency syndrome (AIDS)-defining events
-
CD4 cells >= 500/mm^3
-
Viral load of < 50 copies HIV messenger ribonucleic acid (mRNA)/mm^3 if on cART or < 25,000 copies HIV mRNA if not on cART
-
No zidovudine or stavudine as part of cART Patients who are HIV+ and do not meet all of these criteria will not be eligible for this study
-
No other prior malignancy except for a) adequately treated basal cell or squamous cell skin cancer or b) any diagnosis of malignancy made within the past 2 years earlier, of which there is no clinically evident cancer, and for which the patient has completed all chemotherapy and radiotherapy at least 6 months prior to study registration; prior treatment with AML induction-type chemotherapy is not allowed; concurrent hormonal therapy is allowed
-
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
-
At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base
-
Patients must have complete remission (CR) or CRi, documented by blood and marrow examinations performed within 42 days before this registration
-
Following completion of induction therapy, the blood counts must recover to absolute neutrophil count (ANC) >= 1,000/mcL and platelets >= 90,000/mcL (without transfusion), and must be maintained at these levels during the 7 days prior to registration
-
Patients must have serum creatinine =< 1.5 x IULN and SGOT or SGPT =< 1.5 x IULN within 28 days before registration
-
Patients must have recovered to =< Grade 2 from any induction cycle non-hematologic toxicities
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | United States | 91505 |
2 | Stanford Cancer Institute Palo Alto | Palo Alto | California | United States | 94304 |
3 | University of California Davis Comprehensive Cancer Center | Sacramento | California | United States | 95817 |
4 | Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut | United States | 06105 |
5 | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | United States | 83706 |
6 | Saint Anthony's Health | Alton | Illinois | United States | 62002 |
7 | Decatur Memorial Hospital | Decatur | Illinois | United States | 62526 |
8 | Heartland Cancer Research NCORP | Decatur | Illinois | United States | 62526 |
9 | Advocate Sherman Hospital | Elgin | Illinois | United States | 60123 |
10 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
11 | Good Samaritan Regional Health Center | Mount Vernon | Illinois | United States | 62864 |
12 | Memorial Medical Center | Springfield | Illinois | United States | 62781 |
13 | Franciscan Saint Francis Health-Beech Grove | Beech Grove | Indiana | United States | 46107 |
14 | Reid Health | Richmond | Indiana | United States | 47374 |
15 | Hospital District Sixth of Harper County | Anthony | Kansas | United States | 67003 |
16 | Cancer Center of Kansas - Chanute | Chanute | Kansas | United States | 66720 |
17 | Cancer Center of Kansas - Dodge City | Dodge City | Kansas | United States | 67801 |
18 | Cancer Center of Kansas - El Dorado | El Dorado | Kansas | United States | 67042 |
19 | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | United States | 66701 |
20 | Cancer Center of Kansas-Independence | Independence | Kansas | United States | 67301 |
21 | Cancer Center of Kansas-Kingman | Kingman | Kansas | United States | 67068 |
22 | Lawrence Memorial Hospital | Lawrence | Kansas | United States | 66044 |
23 | Southwest Medical Center | Liberal | Kansas | United States | 67901 |
24 | Cancer Center of Kansas-Liberal | Liberal | Kansas | United States | 67905 |
25 | Cancer Center of Kansas - Newton | Newton | Kansas | United States | 67114 |
26 | Menorah Medical Center | Overland Park | Kansas | United States | 66209 |
27 | Saint Luke's South Hospital | Overland Park | Kansas | United States | 66213 |
28 | Cancer Center of Kansas - Parsons | Parsons | Kansas | United States | 67357 |
29 | Kansas City NCI Community Oncology Research Program | Prairie Village | Kansas | United States | 66208 |
30 | Cancer Center of Kansas - Pratt | Pratt | Kansas | United States | 67124 |
31 | Cancer Center of Kansas - Salina | Salina | Kansas | United States | 67401 |
32 | Salina Regional Health Center | Salina | Kansas | United States | 67401 |
33 | Advent Health - Shawnee Mission Medical Center | Shawnee Mission | Kansas | United States | 66204 |
34 | Cotton O'Neil Cancer Center / Stormont Vail Health | Topeka | Kansas | United States | 66606 |
35 | Cancer Center of Kansas - Wellington | Wellington | Kansas | United States | 67152 |
36 | Associates In Womens Health | Wichita | Kansas | United States | 67208 |
37 | Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas | United States | 67208 |
38 | Ascension Via Christi Hospitals Wichita | Wichita | Kansas | United States | 67214 |
39 | Cancer Center of Kansas - Wichita | Wichita | Kansas | United States | 67214 |
40 | Wesley Medical Center | Wichita | Kansas | United States | 67214 |
41 | Wichita NCI Community Oncology Research Program | Wichita | Kansas | United States | 67214 |
42 | Cancer Center of Kansas - Winfield | Winfield | Kansas | United States | 67156 |
43 | University of Kentucky/Markey Cancer Center | Lexington | Kentucky | United States | 40536 |
44 | Hematology/Oncology Clinic PLLC | Baton Rouge | Louisiana | United States | 70809 |
45 | Tulane University Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
46 | Michigan Cancer Research Consortium NCORP | Ann Arbor | Michigan | United States | 48106 |
47 | Saint Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48106 |
48 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109 |
49 | Bronson Battle Creek | Battle Creek | Michigan | United States | 49017 |
50 | Spectrum Health Big Rapids Hospital | Big Rapids | Michigan | United States | 49307 |
51 | Beaumont Hospital - Dearborn | Dearborn | Michigan | United States | 48124 |
52 | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
53 | Ascension Saint John Hospital | Detroit | Michigan | United States | 48236 |
54 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
55 | Genesys Regional Medical Center-West Flint Campus | Flint | Michigan | United States | 48532 |
56 | Cancer Research Consortium of West Michigan NCORP | Grand Rapids | Michigan | United States | 49503 |
57 | Mercy Health Saint Mary's | Grand Rapids | Michigan | United States | 49503 |
58 | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | United States | 49503 |
59 | Allegiance Health | Jackson | Michigan | United States | 49201 |
60 | Sparrow Hospital | Lansing | Michigan | United States | 48912 |
61 | Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan | United States | 48154 |
62 | Mercy Health Mercy Campus | Muskegon | Michigan | United States | 49444 |
63 | Saint Joseph Mercy Oakland | Pontiac | Michigan | United States | 48341 |
64 | Lake Huron Medical Center | Port Huron | Michigan | United States | 48060 |
65 | Ascension Saint Mary's Hospital | Saginaw | Michigan | United States | 48601 |
66 | Ascension Providence Hospitals - Southfield | Southfield | Michigan | United States | 48075 |
67 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
68 | Saint John Macomb-Oakland Hospital | Warren | Michigan | United States | 48093 |
69 | Metro Health Hospital | Wyoming | Michigan | United States | 49519 |
70 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
71 | Southeast Missouri Hospital | Cape Girardeau | Missouri | United States | 63701 |
72 | Saint Francis Medical Center | Cape Girardeau | Missouri | United States | 63703 |
73 | Truman Medical Centers | Kansas City | Missouri | United States | 64108 |
74 | Saint Luke's Hospital of Kansas City | Kansas City | Missouri | United States | 64111 |
75 | Saint Joseph Health Center | Kansas City | Missouri | United States | 64114 |
76 | North Kansas City Hospital | Kansas City | Missouri | United States | 64116 |
77 | Heartland Hematology and Oncology Associates Incorporated | Kansas City | Missouri | United States | 64118 |
78 | Research Medical Center | Kansas City | Missouri | United States | 64132 |
79 | Saint Luke's East - Lee's Summit | Lee's Summit | Missouri | United States | 64086 |
80 | Liberty Radiation Oncology Center | Liberty | Missouri | United States | 64068 |
81 | Heartland Regional Medical Center | Saint Joseph | Missouri | United States | 64506 |
82 | Saint Joseph Oncology Inc | Saint Joseph | Missouri | United States | 64507 |
83 | Saint Louis Cancer and Breast Institute-South City | Saint Louis | Missouri | United States | 63109 |
84 | Mercy Hospital Saint Louis | Saint Louis | Missouri | United States | 63141 |
85 | Saint Louis-Cape Girardeau CCOP | Saint Louis | Missouri | United States | 63141 |
86 | Billings Clinic Cancer Center | Billings | Montana | United States | 59101 |
87 | Northern Rockies Radiation Oncology Center | Billings | Montana | United States | 59101 |
88 | Saint Vincent Healthcare | Billings | Montana | United States | 59101 |
89 | Montana Cancer Consortium NCORP | Billings | Montana | United States | 59102 |
90 | Saint Vincent Frontier Cancer Center | Billings | Montana | United States | 59102 |
91 | Bozeman Deaconess Hospital | Bozeman | Montana | United States | 59715 |
92 | Saint James Community Hospital and Cancer Treatment Center | Butte | Montana | United States | 59701 |
93 | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana | United States | 59405 |
94 | Berdeaux, Donald MD (UIA Investigator) | Great Falls | Montana | United States | 59405 |
95 | Great Falls Clinic | Great Falls | Montana | United States | 59405 |
96 | Northern Montana Hospital | Havre | Montana | United States | 59501 |
97 | Saint Peter's Community Hospital | Helena | Montana | United States | 59601 |
98 | Glacier Oncology PLLC | Kalispell | Montana | United States | 59901 |
99 | Kalispell Medical Oncology | Kalispell | Montana | United States | 59901 |
100 | Kalispell Regional Medical Center | Kalispell | Montana | United States | 59901 |
101 | Montana Cancer Specialists | Missoula | Montana | United States | 59802 |
102 | Saint Patrick Hospital - Community Hospital | Missoula | Montana | United States | 59802 |
103 | Community Medical Hospital | Missoula | Montana | United States | 59804 |
104 | Guardian Oncology and Center for Wellness | Missoula | Montana | United States | 59804 |
105 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87102 |
106 | University of Rochester | Rochester | New York | United States | 14642 |
107 | Novant Health Presbyterian Medical Center | Charlotte | North Carolina | United States | 28204 |
108 | Wayne Memorial Hospital | Goldsboro | North Carolina | United States | 27534 |
109 | Margaret R Pardee Memorial Hospital | Hendersonville | North Carolina | United States | 28791 |
110 | Rutherford Hospital | Rutherfordton | North Carolina | United States | 28139 |
111 | Southeast Clinical Oncology Research Consortium NCORP | Winston-Salem | North Carolina | United States | 27104 |
112 | Cleveland Clinic Akron General | Akron | Ohio | United States | 44307 |
113 | Mary Rutan Hospital | Bellefontaine | Ohio | United States | 43311 |
114 | Adena Regional Medical Center | Chillicothe | Ohio | United States | 45601 |
115 | University of Cincinnati Cancer Center-UC Medical Center | Cincinnati | Ohio | United States | 45219 |
116 | Riverside Methodist Hospital | Columbus | Ohio | United States | 43214 |
117 | Columbus NCI Community Oncology Research Program | Columbus | Ohio | United States | 43215 |
118 | Grant Medical Center | Columbus | Ohio | United States | 43215 |
119 | Mount Carmel Health Center West | Columbus | Ohio | United States | 43222 |
120 | Doctors Hospital | Columbus | Ohio | United States | 43228 |
121 | Grandview Hospital | Dayton | Ohio | United States | 45405 |
122 | Good Samaritan Hospital - Dayton | Dayton | Ohio | United States | 45406 |
123 | Miami Valley Hospital | Dayton | Ohio | United States | 45409 |
124 | Miami Valley Hospital North | Dayton | Ohio | United States | 45415 |
125 | Dayton NCI Community Oncology Research Program | Dayton | Ohio | United States | 45459 |
126 | Grady Memorial Hospital | Delaware | Ohio | United States | 43015 |
127 | Blanchard Valley Hospital | Findlay | Ohio | United States | 45840 |
128 | Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio | United States | 45005-1066 |
129 | Wayne Hospital | Greenville | Ohio | United States | 45331 |
130 | Kettering Medical Center | Kettering | Ohio | United States | 45429 |
131 | Fairfield Medical Center | Lancaster | Ohio | United States | 43130 |
132 | Marietta Memorial Hospital | Marietta | Ohio | United States | 45750 |
133 | Knox Community Hospital | Mount Vernon | Ohio | United States | 43050 |
134 | Licking Memorial Hospital | Newark | Ohio | United States | 43055 |
135 | Southern Ohio Medical Center | Portsmouth | Ohio | United States | 45662 |
136 | Springfield Regional Medical Center | Springfield | Ohio | United States | 45505 |
137 | Upper Valley Medical Center | Troy | Ohio | United States | 45373 |
138 | Saint Ann's Hospital | Westerville | Ohio | United States | 43081 |
139 | Clinton Memorial Hospital | Wilmington | Ohio | United States | 45177 |
140 | Greene Memorial Hospital | Xenia | Ohio | United States | 45385 |
141 | Genesis Healthcare System Cancer Care Center | Zanesville | Ohio | United States | 43701 |
142 | Clackamas Radiation Oncology Center | Clackamas | Oregon | United States | 97015 |
143 | Legacy Mount Hood Medical Center | Gresham | Oregon | United States | 97030 |
144 | Providence Milwaukie Hospital | Milwaukie | Oregon | United States | 97222 |
145 | Providence Newberg Medical Center | Newberg | Oregon | United States | 97132 |
146 | Providence Willamette Falls Medical Center | Oregon City | Oregon | United States | 97045 |
147 | Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon | United States | 97210 |
148 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
149 | Adventist Medical Center | Portland | Oregon | United States | 97216 |
150 | Providence Saint Vincent Medical Center | Portland | Oregon | United States | 97225 |
151 | Legacy Emanuel Hospital and Health Center | Portland | Oregon | United States | 97227 |
152 | Salem Hospital | Salem | Oregon | United States | 97301 |
153 | Legacy Meridian Park Hospital | Tualatin | Oregon | United States | 97062 |
154 | AnMed Health Hospital | Anderson | South Carolina | United States | 29621 |
155 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
156 | Spartanburg Medical Center | Spartanburg | South Carolina | United States | 29303 |
157 | The Don and Sybil Harrington Cancer Center | Amarillo | Texas | United States | 79106 |
158 | Cancer Care Center at Island Hospital | Anacortes | Washington | United States | 98221 |
159 | PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | United States | 98225 |
160 | Harrison HealthPartners Hematology and Oncology-Bremerton | Bremerton | Washington | United States | 98310 |
161 | Highline Medical Center-Main Campus | Burien | Washington | United States | 98166 |
162 | Swedish Cancer Institute-Issaquah | Issaquah | Washington | United States | 98029 |
163 | Kadlec Clinic Hematology and Oncology | Kennewick | Washington | United States | 99336 |
164 | Skagit Valley Hospital | Mount Vernon | Washington | United States | 98274 |
165 | Harrison HealthPartners Hematology and Oncology-Poulsbo | Poulsbo | Washington | United States | 98370 |
166 | Harborview Medical Center | Seattle | Washington | United States | 98104 |
167 | Minor and James Medical PLLC | Seattle | Washington | United States | 98104 |
168 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109 |
169 | Kaiser Permanente Washington | Seattle | Washington | United States | 98112 |
170 | Swedish Medical Center-First Hill | Seattle | Washington | United States | 98122-4307 |
171 | University of Washington Medical Center - Montlake | Seattle | Washington | United States | 98195 |
172 | PeaceHealth United General Medical Center | Sedro-Woolley | Washington | United States | 98284 |
173 | Cancer Care Northwest - Spokane South | Spokane | Washington | United States | 99202 |
174 | Evergreen Hematology and Oncology PS | Spokane | Washington | United States | 99218 |
175 | PeaceHealth Southwest Medical Center | Vancouver | Washington | United States | 98664 |
176 | Wenatchee Valley Hospital and Clinics | Wenatchee | Washington | United States | 98801 |
177 | Rocky Mountain Oncology | Casper | Wyoming | United States | 82609 |
178 | Welch Cancer Center | Sheridan | Wyoming | United States | 82801 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Sucha Nand, Southwest Oncology Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCI-2009-00790
- NCI-2009-00790
- SWOG-S0703
- CDR0000593117
- S0703
- S0703
- U10CA032102
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin |
---|---|---|
Arm/Group Description | Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy. Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Patients in continued remission may go on to receive maintenance therapy. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) | Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy. Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Patients in continued remission may go on to receive maintenance therapy. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) |
Period Title: Remission Induction Chemotherapy | ||
STARTED | 83 | 59 |
Eligible | 82 | 57 |
Eligible and Began Protocol Therapy | 79 | 54 |
COMPLETED | 75 | 41 |
NOT COMPLETED | 8 | 18 |
Period Title: Remission Induction Chemotherapy | ||
STARTED | 24 | 13 |
Eligible | 22 | 11 |
COMPLETED | 22 | 10 |
NOT COMPLETED | 2 | 3 |
Period Title: Remission Induction Chemotherapy | ||
STARTED | 20 | 8 |
Eligible | 19 | 8 |
COMPLETED | 17 | 7 |
NOT COMPLETED | 3 | 1 |
Baseline Characteristics
Arm/Group Title | Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Total |
---|---|---|---|
Arm/Group Description | Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) | Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) | Total of all reporting groups |
Overall Participants | 79 | 54 | 133 |
Age (years) [Median (Full Range) ] | |||
Median (Full Range) [years] |
71.2
|
76
|
73.4
|
Sex: Female, Male (Count of Participants) | |||
Female |
30
38%
|
21
38.9%
|
51
38.3%
|
Male |
49
62%
|
33
61.1%
|
82
61.7%
|
Race/Ethnicity, Customized (participants) [Number] | |||
Asian |
1
1.3%
|
0
0%
|
1
0.8%
|
Black or African American |
1
1.3%
|
4
7.4%
|
5
3.8%
|
White |
77
97.5%
|
50
92.6%
|
127
95.5%
|
Hispanic (participants) [Number] | |||
Yes |
3
3.8%
|
1
1.9%
|
4
3%
|
No |
64
81%
|
50
92.6%
|
114
85.7%
|
Unknown |
12
15.2%
|
3
5.6%
|
15
11.3%
|
Outcome Measures
Title | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug |
---|---|
Description | Only adverse events that are possibly, probably or definitely related to study drug are reported. |
Time Frame | Up to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. |
Arm/Group Title | Remission Induction Chemotherapy | Consolidation Therapy | Maintenance Therapy |
---|---|---|---|
Arm/Group Description | Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) | Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. | Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) |
Measure Participants | 133 | 32 | 27 |
ALT, SGPT (serum glutamic pyruvic transaminase) |
5
6.3%
|
0
0%
|
0
0%
|
AST, SGOT |
4
5.1%
|
0
0%
|
0
0%
|
Adult respiratory distress syndrome (ARDS) |
1
1.3%
|
0
0%
|
0
0%
|
Albumin, serum-low (hypoalbuminemia) |
5
6.3%
|
1
1.9%
|
0
0%
|
Anorexia |
5
6.3%
|
1
1.9%
|
0
0%
|
Bilirubin (hyperbilirubinemia) |
3
3.8%
|
0
0%
|
0
0%
|
Calcium, serum-low (hypocalcemia) |
6
7.6%
|
0
0%
|
0
0%
|
Carbon monoxide diffusion capacity (DL(co)) |
1
1.3%
|
0
0%
|
0
0%
|
Cardiac Arrhythmia-Atrial fibrilation |
1
1.3%
|
0
0%
|
0
0%
|
Cardiac General-cardiopulmonary disease |
1
1.3%
|
0
0%
|
0
0%
|
Cardiac General-Chest Pain |
1
1.3%
|
0
0%
|
0
0%
|
Cardiac troponin I (cTnI) |
1
1.3%
|
0
0%
|
0
0%
|
Cardiac-ischemia/infarction |
1
1.3%
|
0
0%
|
0
0%
|
Conduction abnormality NOS |
1
1.3%
|
0
0%
|
0
0%
|
Confusion |
1
1.3%
|
0
0%
|
0
0%
|
Constipation |
2
2.5%
|
0
0%
|
0
0%
|
Cytokine release syndrome/acute infusion reaction |
1
1.3%
|
0
0%
|
0
0%
|
Death - Disease progression NOS |
1
1.3%
|
0
0%
|
0
0%
|
Death - Multi-organ failure |
2
2.5%
|
0
0%
|
0
0%
|
Death not associated with CTCAE term - Death NOS |
1
1.3%
|
0
0%
|
0
0%
|
Dehydration |
1
1.3%
|
0
0%
|
0
0%
|
Diarrhea |
2
2.5%
|
0
0%
|
0
0%
|
Dyspnea (shortness of breath) |
5
6.3%
|
1
1.9%
|
2
1.5%
|
Edema: limb |
1
1.3%
|
0
0%
|
0
0%
|
Fatigue (asthenia, lethargy, malaise) |
18
22.8%
|
1
1.9%
|
1
0.8%
|
Febrile neutropenia |
50
63.3%
|
0
0%
|
0
0%
|
Glucose, serum-high (hyperglycemia) |
10
12.7%
|
3
5.6%
|
2
1.5%
|
Hemoglobin |
73
92.4%
|
1
1.9%
|
1
0.8%
|
Hemorrhage, CNS |
1
1.3%
|
0
0%
|
0
0%
|
Hemorrhage, GI - Stomach |
1
1.3%
|
0
0%
|
0
0%
|
Hemorrhage, GI - Upper GI NOS |
1
1.3%
|
0
0%
|
0
0%
|
Hemorrhage/Bleeding-platelets and red blood cells |
1
1.3%
|
0
0%
|
0
0%
|
Hepatobiliary/Pancreas-venoocclusive disease |
1
1.3%
|
0
0%
|
0
0%
|
Hypertension |
1
1.3%
|
0
0%
|
0
0%
|
Hypotension |
2
2.5%
|
0
0%
|
0
0%
|
Hypoxia |
4
5.1%
|
0
0%
|
0
0%
|
Inf (clin/microbio) w/Gr 3-4 neuts - Blood |
16
20.3%
|
0
0%
|
1
0.8%
|
Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel |
2
2.5%
|
1
1.9%
|
0
0%
|
Inf (clin/microbio) w/Gr 3-4 neuts - Colon |
1
1.3%
|
0
0%
|
0
0%
|
Inf (clin/microbio) w/Gr 3-4 neuts - Conjunctiva |
1
1.3%
|
0
0%
|
0
0%
|
Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth |
3
3.8%
|
0
0%
|
0
0%
|
Inf (clin/microbio) w/Gr 3-4 neuts - Kidney |
1
1.3%
|
0
0%
|
0
0%
|
Inf (clin/microbio) w/Gr 3-4 neuts - Lung |
8
10.1%
|
0
0%
|
0
0%
|
Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums |
1
1.3%
|
0
0%
|
0
0%
|
Inf (clin/microbio) w/Gr 3-4 neuts - Sinus |
2
2.5%
|
0
0%
|
0
0%
|
Inf (clin/microbio) w/Gr 3-4 neuts - Skin |
6
7.6%
|
0
0%
|
0
0%
|
Inf (clin/microbio) w/Gr 3-4 neuts - UTI |
3
3.8%
|
0
0%
|
0
0%
|
Inf w/normal ANC or Gr 1-2 neutrophils - Blood |
2
2.5%
|
1
1.9%
|
0
0%
|
Inf w/normal ANC or Gr 1-2 neutrophils - Lung |
0
0%
|
0
0%
|
1
0.8%
|
Inf w/normal ANC or Gr 1-2 neutrophils - Skin |
1
1.3%
|
0
0%
|
0
0%
|
Infection with unknown ANC - Blood |
1
1.3%
|
0
0%
|
0
0%
|
Infection with unknown ANC - Lung (pneumonia) |
1
1.3%
|
0
0%
|
0
0%
|
Infection with unknown ANC - Skin (cellulitis) |
1
1.3%
|
0
0%
|
0
0%
|
Infection-Aspirgillosis |
1
1.3%
|
0
0%
|
0
0%
|
Infection-bacteremia |
1
1.3%
|
0
0%
|
0
0%
|
Left ventricular systolic dysfunction |
1
1.3%
|
0
0%
|
0
0%
|
Leukocytes (total WBC) |
80
101.3%
|
18
33.3%
|
6
4.5%
|
Liver dysfunction/failure (clinical) |
0
0%
|
1
1.9%
|
0
0%
|
Lymphopenia |
23
29.1%
|
0
0%
|
1
0.8%
|
Mood alteration - depression |
2
2.5%
|
0
0%
|
0
0%
|
Mucositis/stomatitis (functional/symp) - Oral cav |
1
1.3%
|
0
0%
|
0
0%
|
Muscle weakness, not d/t neuropathy - body/general |
4
5.1%
|
0
0%
|
0
0%
|
Neutrophils/granulocytes (ANC/AGC) |
85
107.6%
|
21
38.9%
|
10
7.5%
|
Pain - Cardiac/heart |
2
2.5%
|
0
0%
|
0
0%
|
Petechiae/purpura (hemorrhage into skin or mucosa) |
1
1.3%
|
0
0%
|
0
0%
|
Phosphate, serum-low (hypophosphatemia) |
4
5.1%
|
0
0%
|
0
0%
|
Platelets |
85
107.6%
|
12
22.2%
|
3
2.3%
|
Pleural effusion (non-malignant) |
1
1.3%
|
0
0%
|
0
0%
|
Pneumonitis/pulmonary infiltrates |
1
1.3%
|
0
0%
|
0
0%
|
Potassium, serum-low (hypokalemia) |
5
6.3%
|
0
0%
|
0
0%
|
Pulmonary/Upper Respiratory-pulmonary edema |
2
2.5%
|
0
0%
|
0
0%
|
Rash/desquamation |
1
1.3%
|
0
0%
|
0
0%
|
SVT and nodal arrhythmia - Atrial fibrillation |
2
2.5%
|
0
0%
|
0
0%
|
SVT and nodal arrhythmia - SVT tachycardia |
1
1.3%
|
0
0%
|
0
0%
|
Sodium, serum-low (hyponatremia) |
5
6.3%
|
0
0%
|
0
0%
|
Sudden death |
1
1.3%
|
0
0%
|
0
0%
|
Thrombosis/thrombus/embolism |
2
2.5%
|
0
0%
|
0
0%
|
Title | Complete Response |
---|---|
Description | Morphologic complete remission (CR): ANC >=1,000/mcL, platelet count >=100,000/mcL, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcL and/or platelet count <100,000/mcL. |
Time Frame | Up to 60 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin |
---|---|---|
Arm/Group Description | Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) | Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) |
Measure Participants | 79 | 54 |
Number (95% Confidence Interval) [percentage of participants] |
44
55.7%
|
35
64.8%
|
Title | 30-Day Survival |
---|---|
Description | Patients surviving more than 30 days after study registration |
Time Frame | 30 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin |
---|---|---|
Arm/Group Description | Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) | Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) |
Measure Participants | 79 | 54 |
Number (95% Confidence Interval) [percentage of participants] |
92
116.5%
|
87
161.1%
|
Title | Relapse-free Survival |
---|---|
Description | Relapse-free survival (RFS) is defined for all patients who achieve CR or CRi. RFS is measured from the date CR or CRi is first achieved until relapse or death form any cause, with observation censored on the date of last contact for patients last known to be alive without report of relapse. Relapse from CR/CRi is defined as reappearance of leukemic blasts in the peripheral blood; or > 5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease. |
Time Frame | Up to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin | Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin |
---|---|---|
Arm/Group Description | Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) | Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3. Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) |
Measure Participants | 35 | 19 |
Median (95% Confidence Interval) [months] |
8
|
7
|
Adverse Events
Time Frame | Up to 5 years | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | Remission Induction Chemotherapy | Consolidation Therapy | Maintenance Therapy | |||
Arm/Group Description | Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days) | Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. | Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days) | |||
All Cause Mortality |
||||||
Remission Induction Chemotherapy | Consolidation Therapy | Maintenance Therapy | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
Remission Induction Chemotherapy | Consolidation Therapy | Maintenance Therapy | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 55/133 (41.4%) | 1/32 (3.1%) | 3/27 (11.1%) | |||
Blood and lymphatic system disorders | ||||||
Febrile neutropenia | 10/133 (7.5%) | 0/32 (0%) | 0/27 (0%) | |||
Hemoglobin | 4/133 (3%) | 0/32 (0%) | 0/27 (0%) | |||
Cardiac disorders | ||||||
Cardiac-ischemia/infarction | 2/133 (1.5%) | 0/32 (0%) | 0/27 (0%) | |||
Conduction abnormality NOS | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Left ventricular systolic dysfunction | 2/133 (1.5%) | 0/32 (0%) | 0/27 (0%) | |||
Pain - Cardiac/heart | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
SVT and nodal arrhythmia - Atrial fibrillation | 3/133 (2.3%) | 0/32 (0%) | 0/27 (0%) | |||
SVT and nodal arrhythmia - SVT tachycardia | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
SVT and nodal arrhythmia - Sinus tachycardia | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Ventricular arrhythmia - Ventricular fibrillation | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Gastrointestinal disorders | ||||||
Colitis | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Hemorrhage, GI - Stomach | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Hemorrhage, GI - Upper GI NOS | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Ileus, GI (functional obstruction of bowel) | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Obstruction, GI - Small bowel NOS | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
General disorders | ||||||
Death - Multi-organ failure | 2/133 (1.5%) | 0/32 (0%) | 0/27 (0%) | |||
Death not associated with CTCAE term - Death NOS | 2/133 (1.5%) | 0/32 (0%) | 0/27 (0%) | |||
Fatigue (asthenia, lethargy, malaise) | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Sudden death | 2/133 (1.5%) | 0/32 (0%) | 0/27 (0%) | |||
Hepatobiliary disorders | ||||||
Liver dysfunction/failure (clinical) | 0/133 (0%) | 1/32 (3.1%) | 0/27 (0%) | |||
Immune system disorders | ||||||
Cytokine release syndrome/acute infusion reaction | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Infections and infestations | ||||||
Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 7/133 (5.3%) | 0/32 (0%) | 0/27 (0%) | |||
Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel | 1/133 (0.8%) | 1/32 (3.1%) | 0/27 (0%) | |||
Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 7/133 (5.3%) | 0/32 (0%) | 0/27 (0%) | |||
Inf (clin/microbio) w/Gr 3-4 neuts - Sinus | 2/133 (1.5%) | 0/32 (0%) | 0/27 (0%) | |||
Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 2/133 (1.5%) | 0/32 (0%) | 0/27 (0%) | |||
Inf (clin/microbio) w/Gr 3-4 neuts - UTI | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Inf w/normal ANC or Gr 1-2 neutrophils - Blood | 3/133 (2.3%) | 0/32 (0%) | 0/27 (0%) | |||
Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 0/133 (0%) | 0/32 (0%) | 1/27 (3.7%) | |||
Infection with unknown ANC - Blood | 2/133 (1.5%) | 0/32 (0%) | 0/27 (0%) | |||
Infection with unknown ANC - Lung (pneumonia) | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Infection-Other (Specify):bacteremia | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Injury, poisoning and procedural complications | ||||||
Fracture | 0/133 (0%) | 0/32 (0%) | 1/27 (3.7%) | |||
Hemorrhage/bleeding w/surgery, intra- or post-op | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Investigations | ||||||
ALT, SGPT (serum glutamic pyruvic transaminase) | 2/133 (1.5%) | 0/32 (0%) | 0/27 (0%) | |||
AST, SGOT | 2/133 (1.5%) | 0/32 (0%) | 0/27 (0%) | |||
Bilirubin (hyperbilirubinemia) | 2/133 (1.5%) | 0/32 (0%) | 0/27 (0%) | |||
Carbon monoxide diffusion capacity (DL(co)) | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Cardiac troponin I (cTnI) | 2/133 (1.5%) | 0/32 (0%) | 0/27 (0%) | |||
Creatinine | 2/133 (1.5%) | 0/32 (0%) | 0/27 (0%) | |||
Leukocytes (total WBC) | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Neutrophils/granulocytes (ANC/AGC) | 3/133 (2.3%) | 0/32 (0%) | 0/27 (0%) | |||
Platelets | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Metabolism and nutrition disorders | ||||||
Acidosis (metabolic or respiratory) | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Albumin, serum-low (hypoalbuminemia) | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Calcium, serum-low (hypocalcemia) | 2/133 (1.5%) | 0/32 (0%) | 0/27 (0%) | |||
Glucose, serum-high (hyperglycemia) | 2/133 (1.5%) | 0/32 (0%) | 1/27 (3.7%) | |||
Magnesium, serum-low (hypomagnesemia) | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Phosphate, serum-low (hypophosphatemia) | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Potassium, serum-high (hyperkalemia) | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Tumor lysis syndrome | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Musculoskeletal and connective tissue disorders | ||||||
Muscle weakness, not d/t neuropathy - body/general | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Pain - Back | 0/133 (0%) | 0/32 (0%) | 1/27 (3.7%) | |||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
Death - Disease progression NOS | 12/133 (9%) | 0/32 (0%) | 0/27 (0%) | |||
Myelodysplasia | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Nervous system disorders | ||||||
CNS cerebrovascular ischemia | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Encephalopathy | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Hemorrhage, CNS | 3/133 (2.3%) | 0/32 (0%) | 0/27 (0%) | |||
Neurology-Other | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Psychiatric disorders | ||||||
Confusion | 2/133 (1.5%) | 0/32 (0%) | 0/27 (0%) | |||
Mood alteration - depression | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Renal and urinary disorders | ||||||
Proteinuria | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Renal failure | 1/133 (0.8%) | 0/32 (0%) | 1/27 (3.7%) | |||
Respiratory, thoracic and mediastinal disorders | ||||||
Carbon monoxide diffusion capacity (DL(co)) | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Cough | 0/133 (0%) | 0/32 (0%) | 1/27 (3.7%) | |||
Dyspnea (shortness of breath) | 5/133 (3.8%) | 0/32 (0%) | 1/27 (3.7%) | |||
Hypoxia | 4/133 (3%) | 0/32 (0%) | 0/27 (0%) | |||
Pleural effusion (non-malignant) | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Pneumonitis/pulmonary infiltrates | 2/133 (1.5%) | 0/32 (0%) | 0/27 (0%) | |||
Pulmonary/Upper Respiratory-Other (Specify):Pulmonary Edema | 2/133 (1.5%) | 0/32 (0%) | 0/27 (0%) | |||
Pulmonary/Upper Respiratory-Other (Specify):Respiratory distress | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Vascular disorders | ||||||
Hypertension | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Hypotension | 6/133 (4.5%) | 0/32 (0%) | 0/27 (0%) | |||
Thrombosis/thrombus/embolism | 3/133 (2.3%) | 0/32 (0%) | 0/27 (0%) | |||
Vascular-Other (Specify):pariatal to occiptal lobe | 1/133 (0.8%) | 0/32 (0%) | 0/27 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Remission Induction Chemotherapy | Consolidation Therapy | Maintenance Therapy | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 130/133 (97.7%) | 32/32 (100%) | 26/27 (96.3%) | |||
Blood and lymphatic system disorders | ||||||
Febrile neutropenia | 49/133 (36.8%) | 1/32 (3.1%) | 0/27 (0%) | |||
Hemoglobin | 98/133 (73.7%) | 20/32 (62.5%) | 15/27 (55.6%) | |||
Eye disorders | ||||||
Watery eye (epiphora, tearing) | 0/133 (0%) | 3/32 (9.4%) | 0/27 (0%) | |||
Gastrointestinal disorders | ||||||
Constipation | 47/133 (35.3%) | 6/32 (18.8%) | 10/27 (37%) | |||
Diarrhea | 35/133 (26.3%) | 1/32 (3.1%) | 7/27 (25.9%) | |||
Heartburn/dyspepsia | 8/133 (6%) | 1/32 (3.1%) | 1/27 (3.7%) | |||
Hemorrhoids | 8/133 (6%) | 0/32 (0%) | 1/27 (3.7%) | |||
Mucositis/stomatitis (clinical exam) - Oral cavity | 12/133 (9%) | 1/32 (3.1%) | 1/27 (3.7%) | |||
Mucositis/stomatitis (functional/symp) - Oral cav | 8/133 (6%) | 1/32 (3.1%) | 0/27 (0%) | |||
Nausea | 56/133 (42.1%) | 5/32 (15.6%) | 5/27 (18.5%) | |||
Pain - Abdomen NOS | 14/133 (10.5%) | 3/32 (9.4%) | 2/27 (7.4%) | |||
Vomiting | 27/133 (20.3%) | 0/32 (0%) | 2/27 (7.4%) | |||
General disorders | ||||||
Edema: limb | 30/133 (22.6%) | 3/32 (9.4%) | 3/27 (11.1%) | |||
Fatigue (asthenia, lethargy, malaise) | 81/133 (60.9%) | 15/32 (46.9%) | 11/27 (40.7%) | |||
Fever in absence of neutropenia, ANC lt1.0x10e9/L | 14/133 (10.5%) | 0/32 (0%) | 1/27 (3.7%) | |||
Injection site reaction/extravasation changes | 9/133 (6.8%) | 5/32 (15.6%) | 9/27 (33.3%) | |||
Pain - Chest/thorax NOS | 7/133 (5.3%) | 1/32 (3.1%) | 1/27 (3.7%) | |||
Rigors/chills | 21/133 (15.8%) | 2/32 (6.3%) | 1/27 (3.7%) | |||
Infections and infestations | ||||||
Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 15/133 (11.3%) | 1/32 (3.1%) | 1/27 (3.7%) | |||
Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 9/133 (6.8%) | 0/32 (0%) | 0/27 (0%) | |||
Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 1/133 (0.8%) | 1/32 (3.1%) | 2/27 (7.4%) | |||
Investigations | ||||||
ALT, SGPT (serum glutamic pyruvic transaminase) | 30/133 (22.6%) | 5/32 (15.6%) | 3/27 (11.1%) | |||
AST, SGOT | 35/133 (26.3%) | 10/32 (31.3%) | 6/27 (22.2%) | |||
Alkaline phosphatase | 22/133 (16.5%) | 4/32 (12.5%) | 4/27 (14.8%) | |||
Bilirubin (hyperbilirubinemia) | 18/133 (13.5%) | 3/32 (9.4%) | 5/27 (18.5%) | |||
Creatinine | 31/133 (23.3%) | 6/32 (18.8%) | 7/27 (25.9%) | |||
Leukocytes (total WBC) | 87/133 (65.4%) | 23/32 (71.9%) | 16/27 (59.3%) | |||
Lymphopenia | 40/133 (30.1%) | 4/32 (12.5%) | 1/27 (3.7%) | |||
Neutrophils/granulocytes (ANC/AGC) | 91/133 (68.4%) | 23/32 (71.9%) | 14/27 (51.9%) | |||
Platelets | 100/133 (75.2%) | 25/32 (78.1%) | 11/27 (40.7%) | |||
Weight loss | 13/133 (9.8%) | 3/32 (9.4%) | 3/27 (11.1%) | |||
Metabolism and nutrition disorders | ||||||
Albumin, serum-low (hypoalbuminemia) | 63/133 (47.4%) | 13/32 (40.6%) | 9/27 (33.3%) | |||
Anorexia | 45/133 (33.8%) | 5/32 (15.6%) | 5/27 (18.5%) | |||
Calcium, serum-high (hypercalcemia) | 3/133 (2.3%) | 3/32 (9.4%) | 3/27 (11.1%) | |||
Calcium, serum-low (hypocalcemia) | 45/133 (33.8%) | 4/32 (12.5%) | 3/27 (11.1%) | |||
Glucose, serum-high (hyperglycemia) | 69/133 (51.9%) | 18/32 (56.3%) | 19/27 (70.4%) | |||
Glucose, serum-low (hypoglycemia) | 7/133 (5.3%) | 2/32 (6.3%) | 3/27 (11.1%) | |||
Magnesium, serum-high (hypermagnesemia) | 11/133 (8.3%) | 0/32 (0%) | 0/27 (0%) | |||
Magnesium, serum-low (hypomagnesemia) | 9/133 (6.8%) | 4/32 (12.5%) | 2/27 (7.4%) | |||
Phosphate, serum-low (hypophosphatemia) | 19/133 (14.3%) | 1/32 (3.1%) | 0/27 (0%) | |||
Potassium, serum-high (hyperkalemia) | 7/133 (5.3%) | 0/32 (0%) | 1/27 (3.7%) | |||
Potassium, serum-low (hypokalemia) | 33/133 (24.8%) | 3/32 (9.4%) | 3/27 (11.1%) | |||
Sodium, serum-low (hyponatremia) | 58/133 (43.6%) | 6/32 (18.8%) | 5/27 (18.5%) | |||
Metabolic/Laboratory - elevated blood urea nitrogen | 11/133 (8.3%) | 1/32 (3.1%) | 2/27 (7.4%) | |||
Musculoskeletal and connective tissue disorders | ||||||
Muscle weakness, not d/t neuropathy - Extrem-lower | 2/133 (1.5%) | 3/32 (9.4%) | 2/27 (7.4%) | |||
Muscle weakness, not d/t neuropathy - body/general | 20/133 (15%) | 2/32 (6.3%) | 2/27 (7.4%) | |||
Pain - Back | 6/133 (4.5%) | 3/32 (9.4%) | 4/27 (14.8%) | |||
Pain - Extremity-limb | 8/133 (6%) | 3/32 (9.4%) | 5/27 (18.5%) | |||
Pain - Joint | 6/133 (4.5%) | 2/32 (6.3%) | 4/27 (14.8%) | |||
Nervous system disorders | ||||||
Dizziness | 16/133 (12%) | 0/32 (0%) | 4/27 (14.8%) | |||
Neuropathy: sensory | 2/133 (1.5%) | 0/32 (0%) | 2/27 (7.4%) | |||
Pain - Head/headache | 14/133 (10.5%) | 0/32 (0%) | 1/27 (3.7%) | |||
Taste alteration (dysgeusia) | 9/133 (6.8%) | 0/32 (0%) | 2/27 (7.4%) | |||
Psychiatric disorders | ||||||
Confusion | 9/133 (6.8%) | 1/32 (3.1%) | 0/27 (0%) | |||
Insomnia | 16/133 (12%) | 5/32 (15.6%) | 2/27 (7.4%) | |||
Mood alteration - anxiety | 12/133 (9%) | 0/32 (0%) | 0/27 (0%) | |||
Mood alteration - depression | 12/133 (9%) | 1/32 (3.1%) | 3/27 (11.1%) | |||
Renal and urinary disorders | ||||||
Glomerular filtration rate | 6/133 (4.5%) | 2/32 (6.3%) | 1/27 (3.7%) | |||
Urinary frequency/urgency | 8/133 (6%) | 0/32 (0%) | 2/27 (7.4%) | |||
Respiratory, thoracic and mediastinal disorders | ||||||
Cough | 26/133 (19.5%) | 0/32 (0%) | 3/27 (11.1%) | |||
Dyspnea (shortness of breath) | 33/133 (24.8%) | 1/32 (3.1%) | 2/27 (7.4%) | |||
Hemorrhage, pulmonary/upper respiratory - Nose | 12/133 (9%) | 0/32 (0%) | 0/27 (0%) | |||
Hypoxia | 10/133 (7.5%) | 0/32 (0%) | 0/27 (0%) | |||
Pleural effusion (non-malignant) | 9/133 (6.8%) | 0/32 (0%) | 0/27 (0%) | |||
Skin and subcutaneous tissue disorders | ||||||
Hair loss/Alopecia (scalp or body) | 1/133 (0.8%) | 2/32 (6.3%) | 3/27 (11.1%) | |||
Nail changes | 0/133 (0%) | 1/32 (3.1%) | 2/27 (7.4%) | |||
Petechiae/purpura (hemorrhage into skin or mucosa) | 16/133 (12%) | 1/32 (3.1%) | 0/27 (0%) | |||
Pruritus/itching | 8/133 (6%) | 0/32 (0%) | 3/27 (11.1%) | |||
Rash/desquamation | 29/133 (21.8%) | 3/32 (9.4%) | 3/27 (11.1%) | |||
Rash: erythema multiforme | 0/133 (0%) | 0/32 (0%) | 2/27 (7.4%) | |||
Sweating (diaphoresis) | 12/133 (9%) | 2/32 (6.3%) | 1/27 (3.7%) | |||
Vascular disorders | ||||||
Hypotension | 11/133 (8.3%) | 0/32 (0%) | 1/27 (3.7%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Study Statistician |
---|---|
Organization | SWOG |
Phone | 206-667-4623 |
- NCI-2009-00790
- NCI-2009-00790
- SWOG-S0703
- CDR0000593117
- S0703
- S0703
- U10CA032102