Guadecitabine With or Without Idarubicin or Cladribine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Study Details
Study Description
Brief Summary
This randomized phase II trial studies how well guadecitabine with or without idarubicin or cladribine works in treating older patients with previously untreated acute myeloid leukemia. Guadecitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin and cladribine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether guadecitabine with or without idarubicin or cladribine is more effective in treating older patients with previously untreated acute myeloid leukemia.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVES:
-
To determine the complete remission (CR) rate, remission duration, leukemia-free survival, and survival in patients >= 70 years with previously untreated acute myeloid leukemia (AML) with 4 different guadecitabine (SGI-110) single agent and SGI-110 based combination regimens.
-
To determine the safety profile and tolerability of the 4 SGI-110 single agent and SGI-110 based combination regimens in patients >= 70 years of age with previously untreated AML.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I:
INDUCTION THERAPY: Patients receive guadecitabine subcutaneously (SC) on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CR with incomplete platelet recovery (CRp) continue on to Maintenance therapy; patients not achieving CR or complete remission with incomplete hematologic recovery (CRi) but deriving clinical benefit may continue to Maintenance therapy at the discretion of the Principal Investigator (PI).
MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
ARM II (CLOSED):
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.
MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
ARM III:
INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin intravenously (IV) over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.
MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
ARM IV (CLOSED):
INDUCTION THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI.
MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every month.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm I (guadecitabine) INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. |
Drug: Guadecitabine
Given SC
Other Names:
|
Experimental: Arm II (CLOSED) (guadecitabine) INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. |
Drug: Guadecitabine
Given SC
Other Names:
|
Experimental: Arm III (guadecitabine, idarubicin) INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. |
Drug: Guadecitabine
Given SC
Other Names:
Drug: Idarubicin
Given IV
Other Names:
|
Experimental: Arm IV (CLOSED) (guadecitabine, cladribine) INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. |
Drug: Cladribine
Given IV
Other Names:
Drug: Guadecitabine
Given SC
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With a Complete Response [Up to 4 years, 3 months]
Complete Response = Complete Remission (CR) + Complete Remission without blood count recovery (CRi) - CR: Neutrophil count >/= 1.0 x 10^9/L and platelet count >/= 100 x 10^9/L, and normal bone marrow differential (</+ 5% blasts). (CRi): Peripheral blood and bonemarrow results as for CR, but with platelet counts of < 100 x 109/L or ANC < 1.0 x 109/L
- Remission Duration [Up to 4 years, 3 months]
The date of Complete Response to the date of loss of response or last follow-up.
- Leukemia-free Survival [Up to 4 years, 3 months]
Survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups. Time from date of treatment start until the date of first objective documentation of disease-relapse.
- Survival [Up to 4 years, 3 months]
Survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups.
- Number of Participants With the Most Frequently Reports Grade 3 or 4 Adverse Event. [Up to 4 years, 3 months]
The most frequently reported adverse events will be determined by the Principal Investigator. The number of participants who experienced the most frequent grade 3 or 4 adverse events will be reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Previously untreated AML patients, except those who have received prior therapy with hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or targeted therapies are allowed
-
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
-
Sign a written informed consent form
-
Total bilirubin =< 2 mg/dL
-
Serum glutamate pyruvate transaminase (SGPT) or serum glutamic oxaloacetic transaminase (SGOT) =< 4 x upper limit of normal (ULN)
-
Creatinine clearance of >= 50 mL/min (estimated by the Cockcroft-Gault [C-G] formula)
-
Male patients must use an effective contraceptive method during the study and for a minimum of 8 weeks after study treatment
-
Baseline left ventricular ejection fraction (LVEF) >= 40%
Exclusion Criteria:
-
Patients with >= New York Heart Association (NYHA) grade 3 heart disease as assessed by history and/or physical examination
-
Patients who received more than one full course of prior hypomethylating agents azacitidine or decitabine
-
Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment
-
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
-
Pregnant or lactating patients
-
Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
-
Any concurrent malignancy with the exception of the following: a) patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; b) patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Hagop M Kantarjian, M.D. Anderson Cancer Center
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 2013-0843
- NCI-2014-00981
- 2013-0843
Study Results
Participant Flow
Recruitment Details | Recruitment Period: April 2014 to July 2018 |
---|---|
Pre-assignment Detail |
Arm/Group Title | Arm I (Guadecitabine) x 5 Days | Arm II (CLOSED) (Guadecitabine) x 10 Days | Arm III (Guadecitabine, Idarubicin) | Arm IV (CLOSED) (Guadecitabine, Cladribine) |
---|---|---|---|---|
Arm/Group Description | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC Idarubicin: Given IV | INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cladribine: Given IV Guadecitabine: Given SC |
Period Title: Overall Study | ||||
STARTED | 13 | 9 | 13 | 9 |
COMPLETED | 13 | 9 | 13 | 9 |
NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Arm I (Guadecitabine) x 5 Days | Arm II (CLOSED) (Guadecitabine) x 10 Days | Arm III (Guadecitabine, Idarubicin) | Arm IV (CLOSED) (Guadecitabine, Cladribine) | Total |
---|---|---|---|---|---|
Arm/Group Description | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC Idarubicin: Given IV | INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cladribine: Given IV Guadecitabine: Given SC | Total of all reporting groups |
Overall Participants | 13 | 9 | 13 | 9 | 44 |
Age (Count of Participants) | |||||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
>=65 years |
13
100%
|
9
100%
|
13
100%
|
9
100%
|
44
100%
|
Age (years) [Median (Full Range) ] | |||||
Median (Full Range) [years] |
73
|
76
|
75
|
76
|
75
|
Sex: Female, Male (Count of Participants) | |||||
Female |
2
15.4%
|
4
44.4%
|
4
30.8%
|
2
22.2%
|
12
27.3%
|
Male |
11
84.6%
|
5
55.6%
|
9
69.2%
|
7
77.8%
|
32
72.7%
|
Race (NIH/OMB) (Count of Participants) | |||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
1
7.7%
|
0
0%
|
0
0%
|
0
0%
|
1
2.3%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
White |
11
84.6%
|
8
88.9%
|
13
100%
|
9
100%
|
41
93.2%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
1
7.7%
|
1
11.1%
|
0
0%
|
0
0%
|
2
4.5%
|
Region of Enrollment (participants) [Number] | |||||
United States |
13
100%
|
9
100%
|
13
100%
|
9
100%
|
44
100%
|
Outcome Measures
Title | Number of Participants With a Complete Response |
---|---|
Description | Complete Response = Complete Remission (CR) + Complete Remission without blood count recovery (CRi) - CR: Neutrophil count >/= 1.0 x 10^9/L and platelet count >/= 100 x 10^9/L, and normal bone marrow differential (</+ 5% blasts). (CRi): Peripheral blood and bonemarrow results as for CR, but with platelet counts of < 100 x 109/L or ANC < 1.0 x 109/L |
Time Frame | Up to 4 years, 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Arm I (Guadecitabine) x 5 Days | Arm II (CLOSED) (Guadecitabine) x 10 Days | Arm III (Guadecitabine, Idarubicin) | Arm IV (CLOSED) (Guadecitabine, Cladribine) |
---|---|---|---|---|
Arm/Group Description | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC Idarubicin: Given IV | INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cladribine: Given IV Guadecitabine: Given SC |
Measure Participants | 13 | 9 | 13 | 9 |
Count of Participants [Participants] |
5
38.5%
|
5
55.6%
|
10
76.9%
|
0
0%
|
Title | Remission Duration |
---|---|
Description | The date of Complete Response to the date of loss of response or last follow-up. |
Time Frame | Up to 4 years, 3 months |
Outcome Measure Data
Analysis Population Description |
---|
Zero participants in the guadecitabine + Cladribine arm had a Complete Response. |
Arm/Group Title | Arm I (Guadecitabine) x 5 Days | Arm II (CLOSED) (Guadecitabine) x 10 Days | Arm III (Guadecitabine, Idarubicin) | Arm IV (CLOSED) (Guadecitabine, Cladribine) |
---|---|---|---|---|
Arm/Group Description | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC Idarubicin: Given IV | INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cladribine: Given IV Guadecitabine: Given SC |
Measure Participants | 5 | 5 | 10 | 0 |
Median (Full Range) [Months] |
7.4
|
14.2
|
5.3
|
Title | Leukemia-free Survival |
---|---|
Description | Survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups. Time from date of treatment start until the date of first objective documentation of disease-relapse. |
Time Frame | Up to 4 years, 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Arm I (Guadecitabine) x 5 Days | Arm II (CLOSED) (Guadecitabine) x 10 Days | Arm III (Guadecitabine, Idarubicin) | Arm IV (CLOSED) (Guadecitabine, Cladribine) |
---|---|---|---|---|
Arm/Group Description | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC Idarubicin: Given IV | INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cladribine: Given IV Guadecitabine: Given SC |
Measure Participants | 13 | 9 | 13 | 9 |
Median (Full Range) [Months] |
4.2
|
10.0
|
7.4
|
4.3
|
Title | Survival |
---|---|
Description | Survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups. |
Time Frame | Up to 4 years, 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Arm I (Guadecitabine) x 5 Days | Arm II (CLOSED) (Guadecitabine) x 10 Days | Arm III (Guadecitabine, Idarubicin) | Arm IV (CLOSED) (Guadecitabine, Cladribine) |
---|---|---|---|---|
Arm/Group Description | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC Idarubicin: Given IV | INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cladribine: Given IV Guadecitabine: Given SC |
Measure Participants | 13 | 9 | 13 | 9 |
Median (Full Range) [Months] |
13.1
|
13.0
|
15.4
|
11.9
|
Title | Number of Participants With the Most Frequently Reports Grade 3 or 4 Adverse Event. |
---|---|
Description | The most frequently reported adverse events will be determined by the Principal Investigator. The number of participants who experienced the most frequent grade 3 or 4 adverse events will be reported. |
Time Frame | Up to 4 years, 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Arm I (Guadecitabine) x 5 Days | Arm II (CLOSED) (Guadecitabine) x 10 Days | Arm III (Guadecitabine, Idarubicin) | Arm IV (CLOSED) (Guadecitabine, Cladribine) |
---|---|---|---|---|
Arm/Group Description | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC Idarubicin: Given IV | INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cladribine: Given IV Guadecitabine: Given SC |
Measure Participants | 13 | 9 | 13 | 9 |
Infection/Sepsis |
4
30.8%
|
8
88.9%
|
8
61.5%
|
9
100%
|
Febrile Neutropenia |
5
38.5%
|
2
22.2%
|
4
30.8%
|
9
100%
|
Fatigue |
0
0%
|
0
0%
|
3
23.1%
|
0
0%
|
Adverse Events
Time Frame | Up to 4 years, 3 months | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||
Arm/Group Title | Arm I (Guadecitabine) x 5 Days | Arm II (CLOSED) (Guadecitabine) x 10 Days | Arm III (Guadecitabine, Idarubicin) | Arm IV (CLOSED) (Guadecitabine, Cladribine) | ||||
Arm/Group Description | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine as in Induction therapy. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-10. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 (days 1-10 of courses 1 and 2). Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC | INDUCTION THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on days 1-2. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC on days 1-5 and idarubicin IV over up to 1 hour on day 1. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Guadecitabine: Given SC Idarubicin: Given IV | INDUCTION THERPAY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-6 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a CR or CRp continue on to Maintenance therapy; patients not achieving CR or CRi but deriving clinical benefit may continue to Maintenance therapy at the discretion of the PI. MAINTENANCE THERAPY: Patients receive guadecitabine SC and cladribine IV over up to 1 hour on days 1-5. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cladribine: Given IV Guadecitabine: Given SC | ||||
All Cause Mortality |
||||||||
Arm I (Guadecitabine) x 5 Days | Arm II (CLOSED) (Guadecitabine) x 10 Days | Arm III (Guadecitabine, Idarubicin) | Arm IV (CLOSED) (Guadecitabine, Cladribine) | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/13 (15.4%) | 1/9 (11.1%) | 1/13 (7.7%) | 2/9 (22.2%) | ||||
Serious Adverse Events |
||||||||
Arm I (Guadecitabine) x 5 Days | Arm II (CLOSED) (Guadecitabine) x 10 Days | Arm III (Guadecitabine, Idarubicin) | Arm IV (CLOSED) (Guadecitabine, Cladribine) | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 9/13 (69.2%) | 7/9 (77.8%) | 10/13 (76.9%) | 6/9 (66.7%) | ||||
Blood and lymphatic system disorders | ||||||||
Anemia | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Neutropenic Fever | 4/13 (30.8%) | 7 | 2/9 (22.2%) | 3 | 4/13 (30.8%) | 5 | 6/9 (66.7%) | 9 |
Cardiac disorders | ||||||||
Acute Coronary Syndrome | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Atrial Fibrillation | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Chest Pain | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Heart Failure | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 3 | 0/9 (0%) | 0 |
Myocardial Infarction | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
Sinus bradycardia | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Supraventricular tachycardia | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Gastrointestinal disorders | ||||||||
Dehydration | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Diarrhea | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Ileus | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Nausea | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
General disorders | ||||||||
Back Pain | 0/13 (0%) | 0 | 1/9 (11.1%) | 2 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Death | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Fatigue | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Fever | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Non-Cardiac Chest Pain | 1/13 (7.7%) | 1 | 1/9 (11.1%) | 1 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Pain Extremity | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
Hepatobiliary disorders | ||||||||
Gallbladder infection | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Infections and infestations | ||||||||
Breast Infection | 0/13 (0%) | 0 | 1/9 (11.1%) | 2 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Catheter related infection | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Infection | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Lung infection | 4/13 (30.8%) | 4 | 3/9 (33.3%) | 3 | 3/13 (23.1%) | 3 | 0/9 (0%) | 0 |
Sepsis | 1/13 (7.7%) | 1 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Sinusitis | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Skin Infection | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
Soft tissue infection | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Urinary tract infeciton | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||||
Fall | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||||
Muscle Weakness | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Myositis | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
Neoplasms benign, malignant and unspecified | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Nervous system disorders | ||||||||
Dizziness | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Seizure | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Renal and urinary disorders | ||||||||
Acute Kidney Injury | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
Urinary Retention | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||
Bronchopulmonary Hemorrhage | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Dyspnea | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 4 | 0/9 (0%) | 0 |
Pleural Effusion | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Respiratory failure | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Vascular disorders | ||||||||
Hypotension | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Thromboembolic Event | 0/13 (0%) | 0 | 1/9 (11.1%) | 2 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
Arm I (Guadecitabine) x 5 Days | Arm II (CLOSED) (Guadecitabine) x 10 Days | Arm III (Guadecitabine, Idarubicin) | Arm IV (CLOSED) (Guadecitabine, Cladribine) | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 13/13 (100%) | 7/9 (77.8%) | 13/13 (100%) | 9/9 (100%) | ||||
Blood and lymphatic system disorders | ||||||||
Anemia | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
Neutropenic Fever | 4/13 (30.8%) | 6 | 1/9 (11.1%) | 2 | 4/13 (30.8%) | 4 | 7/9 (77.8%) | 10 |
Cardiac disorders | ||||||||
Atrial Fibrillation | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 2/13 (15.4%) | 2 | 0/9 (0%) | 0 |
Cardiac Ischemia/Infarction | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
Congestive Heart Failure | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Sinus Bradycardia | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Ventricular arrhythmia--Select | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Gastrointestinal disorders | ||||||||
Anorexia | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 2/13 (15.4%) | 2 | 1/9 (11.1%) | 1 |
Bloating | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Cholecystitis | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Colitis | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
Constipation | 2/13 (15.4%) | 2 | 1/9 (11.1%) | 1 | 6/13 (46.2%) | 6 | 4/9 (44.4%) | 4 |
Diarrhea | 4/13 (30.8%) | 4 | 0/9 (0%) | 0 | 6/13 (46.2%) | 6 | 1/9 (11.1%) | 1 |
Flatulence | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Heartburn | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Mucositis | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 5/9 (55.6%) | 5 |
Nausea | 2/13 (15.4%) | 2 | 2/9 (22.2%) | 2 | 3/13 (23.1%) | 3 | 5/9 (55.6%) | 5 |
Obstruction GI | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Vomiting | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
General disorders | ||||||||
Chest Pain | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Constitutional Symptoms | 2/13 (15.4%) | 2 | 3/9 (33.3%) | 4 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Edema Limb | 3/13 (23.1%) | 3 | 4/9 (44.4%) | 4 | 7/13 (53.8%) | 7 | 1/9 (11.1%) | 1 |
Fatigue | 2/13 (15.4%) | 2 | 1/9 (11.1%) | 1 | 4/13 (30.8%) | 4 | 2/9 (22.2%) | 2 |
Fever | 1/13 (7.7%) | 2 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Flu-like syndrome | 0/13 (0%) | 0 | 2/9 (22.2%) | 2 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Hemorrhage | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 2/13 (15.4%) | 3 | 1/9 (11.1%) | 1 |
Pain | 2/13 (15.4%) | 2 | 2/9 (22.2%) | 2 | 4/13 (30.8%) | 6 | 1/9 (11.1%) | 1 |
Sweating | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Immune system disorders | ||||||||
Allergy | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Infections and infestations | ||||||||
Infection | 3/13 (23.1%) | 5 | 7/9 (77.8%) | 14 | 8/13 (61.5%) | 15 | 6/9 (66.7%) | 11 |
Injury, poisoning and procedural complications | ||||||||
Bruising | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Investigations | ||||||||
Elevated Alanine Aminotransferase | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 2/13 (15.4%) | 2 | 1/9 (11.1%) | 1 |
Elevated Aspartate Aminotransferase | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Hyperbillirubinemia | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 1/13 (7.7%) | 1 | 2/9 (22.2%) | 2 |
Neutropenia | 2/13 (15.4%) | 3 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
thrombocytopenia | 2/13 (15.4%) | 3 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Weight Loss | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Metabolism and nutrition disorders | ||||||||
Dehydration | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Hypomagnesemia | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||||
Muscle weakness | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Musculoskeletal/Soft Tissue-Other (Specify) | 0/13 (0%) | 0 | 2/9 (22.2%) | 2 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Myositis (inflammation/damage of muscle) | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Nervous system disorders | ||||||||
Dizziness | 0/13 (0%) | 0 | 2/9 (22.2%) | 2 | 3/13 (23.1%) | 3 | 1/9 (11.1%) | 1 |
Memory Impairment | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Neurology-Other (Specify) | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Neuropathy | 0/13 (0%) | 0 | 1/9 (11.1%) | 2 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Seizure | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Syncope | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
Tremor | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
Psychiatric disorders | ||||||||
Confusion | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
Insomnia | 4/13 (30.8%) | 4 | 0/9 (0%) | 0 | 4/13 (30.8%) | 4 | 0/9 (0%) | 0 |
Renal and urinary disorders | ||||||||
Bladder Spasms | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Dysuria | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Urinary frequency/urgency | 1/13 (7.7%) | 1 | 1/9 (11.1%) | 1 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Urinary retention (including neurogenic bladder) | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||
Cough | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Dyspnea | 0/13 (0%) | 0 | 2/9 (22.2%) | 2 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Pleural effusion | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Respiratory Failure | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 |
Skin and subcutaneous tissue disorders | ||||||||
Alopecia | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Dermatology Skin/Other | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 1/9 (11.1%) | 2 |
Pruritus/itching | 2/13 (15.4%) | 2 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Rash/desquamation | 5/13 (38.5%) | 5 | 1/9 (11.1%) | 1 | 2/13 (15.4%) | 2 | 2/9 (22.2%) | 2 |
Rash: dermatitis associated with radiation--Select | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Ulceration | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Vascular disorders | ||||||||
Flushing | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Hypotension | 0/13 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/9 (0%) | 0 |
Phlebitis | 0/13 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/9 (0%) | 0 |
Thrombosis/embolism (vascular access-related) | 1/13 (7.7%) | 1 | 2/9 (22.2%) | 3 | 4/13 (30.8%) | 4 | 0/9 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Hagop Kantarjian, MD/Chair |
---|---|
Organization | The University of Texas MD Anderson Cancer Center |
Phone | 713-792-7026 |
hkantarjian@mdanderson.org |
- 2013-0843
- NCI-2014-00981
- 2013-0843