Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy

• Sponsor: Children's Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00070174
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 350
• Locations: 148
• Duration (Months): 120
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as gemtuzumab ozogamicin, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

PURPOSE: This phase II trial is studying how well gemtuzumab ozogamicin works in treating young patients who are undergoing remission induction, intensification therapy, and allogeneic bone marrow transplant for newly diagnosed acute myeloid leukemia.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Drug: asparaginase; Drug: busulfan; Drug: cyclophosphamide; Drug: cyclosporine; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: etoposide; Drug: gemtuzumab ozogamicin; Drug: methotrexate; Drug: mitoxantrone hydrochloride; Procedure: allogeneic bone marrow transplantation	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Determine the safety of gemtuzumab ozogamicin in children with newly diagnosed acute myeloid leukemia undergoing intensive remission induction and intensification therapy.

• Determine the complete remission rate of patients treated with this regimen.

Secondary

• Determine the feasibility of performing biological studies (e.g., FLT3-ITD and MRD) for risk group stratification in these patients.

• Determine the effect of karyotypic abnormalities on survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

• Induction I: Patients receive high-dose cytarabine (ARA-C) IV twice daily on days 1-10; daunorubicin IV over 6 hours on days 1, 3, and 5; etoposide IV over 4 hours on days 1-5; and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS-negative disease receive ARA-C intrathecally (IT) on day 1. Patients with CNS-positive disease receive ARA-C IT twice weekly for 2-3 weeks. Between days 28-35, patients are evaluated. Patients achieving remission or who have no more than 20% blasts proceed to induction II.

• Induction II: Patients receive ARA-C IV twice daily on days 1-8; ARA-C IT on day 1; and daunorubicin IV and etoposide IV as in induction I. Between days 28-35 patients are evaluated. Patients achieving complete remission proceed to intensification course I.

• Intensification course I: Patients receive ARA-C IV over 1 hour twice daily on days 1-5; ARA-C IT as in induction II; and etoposide IV over 1 hour on days 1-5. Patients are evaluated at day 28. Patients with a 5/6 or 6/6 matched family donor proceed to allogeneic bone marrow transplantation. All other patients in complete remission proceed to intensification course II.

• Intensification course II: Patients receive ARA-C IV over 2 hours twice daily on days 1-4; ARA-C IT as in induction II; mitoxantrone IV over 1 hour on days 3-6; and gemtuzumab ozogamicin IV over 2 hours on day 7. Patients are evaluated on day 28 and then proceed to intensification course III.

• Intensification course III: Patients receive ARA-C IV over 3 hours twice daily on days 1, 2, 8, and 9 and asparaginase intramuscularly on days 2 and 9.

• Allogeneic bone marrow transplantation: Patients receive a preparative regimen comprising busulfan IV over 2 hours 4 times daily on days -9 to -6 and cyclophosphamide IV over 1 hour once daily on days -5 to -2. Allogeneic stem cells are infused on day 0.

• Graft-versus-host disease prophylaxis: Patients receive oral or IV cyclosporine twice daily on days -1 to 50 and methotrexate IV once daily on days 1, 3, 6, and 11.

In all courses, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly for 6 months, every 2 months for 6 months, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 330 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 350 participants
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Newly Diagnosed Childhood Acute Myeloid Leukemia (AML) Using Intensive MRC-Based Therapy and Gemtuzumab Ozogamicin (GMTZ): A COG Pilot Study
• Study Start Date: Dec 1, 2003
• Actual Primary Completion Date: Sep 1, 2006
• Actual Study Completion Date: Dec 1, 2013

Outcome Measures

Primary Outcome Measures

1. Safety []

2. Complete remission rate []

Secondary Outcome Measures

1. Feasibility []

2. Effect of karyotypic abnormalities []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Newly diagnosed primary acute myeloid leukemia (AML)

• At least 20% bone marrow blasts

• Meets the customary FAB criteria for AML

• Patients with cytopenias and bone marrow blasts who do not meet the FAB criteria are eligible provided they have a karyotypic abnormality characteristic of de novo AML (e.g., t[8;21], inv16, or t[16;16]) OR they have the unequivocal presence of megakaryoblasts

• Isolated granulocytic sarcoma (myeloblastoma) allowed regardless of the results outlined above

• Previously untreated disease

• No promyelocytic leukemia (FAB M3)

• No documented myelodysplastic syndromes (preleukemia) (e.g., chronic myelomonocytic leukemia, refractory anemia [RA], RA with excess blasts, or RA with ringed sideroblasts)

• No juvenile myelomonocytic leukemia

• No Fanconi's anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome

• No Down syndrome

PATIENT CHARACTERISTICS:

Age

• 1 month to 21 years* NOTE: *Children under 1 month of age who have progressive disease are allowed

Performance status

• Karnofsky 50-100% (over 16 years of age) OR

• Lansky 50-100% (ages 1 to 16)* NOTE: Children under 1 year of age do not require a performance status

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• No inadequate liver function

Renal

• No inadequate renal function

• No hyperuricemia (greater than 8.0 mg/dL)

• Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70 mL/min OR an equivalent normal GFR OR

• Creatinine no greater than 1.5 times normal

Cardiovascular

• Shortening fraction at least 27% by echocardiogram OR

• Ejection fraction at least 50% by MUGA

Pulmonary

• No proven or suspected pneumonia

Other

• Not pregnant or nursing

• No proven or suspected sepsis or meningitis

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy except intrathecal cytarabine administered that was administered at diagnosis

Endocrine therapy

• Prior topical and inhalation steroids allowed

• No concurrent steroids as antiemetics

Radiotherapy

• No prior radiotherapy

Surgery

• Not specified

Other

• No prior antileukemic therapy

• No concurrent pressor agent or ventilatory support unless approved by the study chair

• No concurrent participation in another COG therapeutic study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Cancer Center at University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Phoenix Children's Hospital	Phoenix	Arizona	United States	85016-7710
3	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
4	Southern California Permanente Medical Group	Downey	California	United States	90242-2814
5	Loma Linda University Cancer Institute at Loma Linda University Medical Center	Loma Linda	California	United States	92354-2870
6	Jonathan Jaques Children's Cancer Center at Miller Children's Hospital	Long Beach	California	United States	90801
7	Children's Hospital Los Angeles	Los Angeles	California	United States	90027
8	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center	Los Angeles	California	United States	90048-1865
9	Children's Hospital Central California	Madera	California	United States	93638-8762
10	Children's Hospital and Research Center - Oakland	Oakland	California	United States	94609-1809
11	Children's Hospital of Orange County	Orange	California	United States	92668
12	University of California Davis Cancer Center	Sacramento	California	United States	95817
13	Sutter Cancer Center	Sacramento	California	United States	95819
14	Kaiser Permanente Medical Center - Oakland	Sacramento	California	United States	95825
15	Children's Hospital and Health Center - San Diego	San Diego	California	United States	92123-4282
16	Children's Hospital Cancer Center	Denver	Colorado	United States	80218-1088
17	Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center	Hartford	Connecticut	United States	06106
18	Alfred I. duPont Hospital for Children	Wilmington	Delaware	United States	19899
19	Lombardi Cancer Center at Georgetown University Medical Center	Washington	District of Columbia	United States	20007-2197
20	Children's National Medical Center	Washington	District of Columbia	United States	20010-2970
21	Broward General Medical Center Cancer Center	Ft. Lauderdale	Florida	United States	33316
22	Lee Cancer Care of Lee Memorial Health System	Ft. Myers	Florida	United States	33908
23	University of Florida Shands Cancer Center	Gainesville	Florida	United States	32610
24	Memorial Cancer Institute at Memorial Regional Hospital	Hollywood	Florida	United States	33021
25	Nemours Children's Clinic	Jacksonville	Florida	United States	32207
26	University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida	United States	33101
27	Miami Children's Hospital	Miami	Florida	United States	33155
28	Baptist-South Miami Regional Cancer Program	Miami	Florida	United States	33176
29	Florida Hospital Cancer Institute at Florida Hospital Orlando	Orlando	Florida	United States	32804
30	M.D. Anderson Cancer Center - Orlando	Orlando	Florida	United States	32806
31	Sacred Heart Cancer Center at Sacred Heart Hospital	Pensacola	Florida	United States	32504
32	All Children's Hospital	St. Petersburg	Florida	United States	33701
33	St. Joseph's Cancer Institute at St. Joseph's Hospital	Tampa	Florida	United States	33607
34	Kaplan Cancer Center at St. Mary's Medical Center	West Palm Beach	Florida	United States	33407
35	Emory University Hospital - Atlanta	Atlanta	Georgia	United States	30322
36	Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia	United States	31404-6283
37	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	95813
38	St. Luke's Mountain States Tumor Institute - Boise	Boise	Idaho	United States	83712-6297
39	Children's Memorial Hospital - Chicago	Chicago	Illinois	United States	60614
40	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1463
41	Lutheran General Cancer Care Center	Park Ridge	Illinois	United States	60068-1174
42	Southern Illinois University School of Medicine	Springfield	Illinois	United States	62794-9230
43	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5225
44	St. Vincent Indianapolis Hospital	Indianapolis	Indiana	United States	46260
45	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1083
46	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
47	Wesley Medical Center	Wichita	Kansas	United States	67214
48	Markey Cancer Center at University of Kentucky Chandler Medical Center	Lexington	Kentucky	United States	40506
49	Kosair Children's Hospital	Louisville	Kentucky	United States	40202-1822
50	CancerCare of Maine at Eastern Maine Medial Center	Bangor	Maine	United States	04401
51	Maine Children's Cancer Program	Scarborough	Maine	United States	04074-9308
52	Alvin and Lois Lapidus Cancer Institute at Sinai Hospital	Baltimore	Maryland	United States	21215
53	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21287-5001
54	Floating Hospital for Children	Boston	Massachusetts	United States	02111
55	C.S. Mott Children's Hospital at University of Michigan	Ann Arbor	Michigan	United States	48109-0238
56	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201
57	Breslin Cancer Center at Ingham Regional Medical Center	East Lansing	Michigan	United States	48824-1313
58	Spectrum Health Cancer Care - Butterworth Campus	Grand Rapids	Michigan	United States	49503-2560
59	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Point Woods	Michigan	United States	48236
60	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-5341
61	Children's Hospitals and Clinics - Minneapolis/St. Paul	Minneapolis	Minnesota	United States	55404
62	Fairview University Medical Center - University Campus	Minneapolis	Minnesota	United States	55455-0392
63	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905-0001
64	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
65	Keesler Medical Center - Keesler Air Force Base	Keesler AFB	Mississippi	United States	39534-2511
66	Children's Mercy Hospital	Kansas City	Missouri	United States	64108
67	Cardinal Glennon Children's Hospital	St. Louis	Missouri	United States	63104
68	Siteman Cancer Center at Barnes-Jewish Hospital	St. Louis	Missouri	United States	63110
69	Children's Hospital of Omaha	Omaha	Nebraska	United States	68114-4113
70	Sunrise Hospital and Medical Center	Las Vegas	Nevada	United States	89109-2306
71	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
72	St. Barnabas Medical Center	Livingston	New Jersey	United States	07039
73	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08901
74	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112-2094
75	St. Joseph's Hospital and Medical Center	Paterson	New Jersey	United States	07503
76	University of New Mexico Cancer Research and Treatment Center	Albuquerque	New Mexico	United States	87131-0001
77	Albert Einstein Cancer Center at Albert Einstein College of Medicine	Bronx	New York	United States	10467
78	Brooklyn Hospital Center	Brooklyn	New York	United States	11201-5493
79	Maimonides Medical Center	Brooklyn	New York	United States	11219
80	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
81	Winthrop University Hospital	Mineola	New York	United States	11501
82	Schneider Children's Hospital	New Hyde Park	New York	United States	11040
83	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York	United States	10032-1537
84	SUNY Upstate Medical University Hospital	Syracuse	New York	United States	13210
85	New York Medical College	Valhalla	New York	United States	10595
86	Mission Hospitals - Memorial Campus	Asheville	North Carolina	United States	28801-4690
87	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599-7220
88	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina	United States	28232
89	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina	United States	28233
90	Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital	Greenville	North Carolina	United States	27834
91	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1081
92	CCOP - MeritCare Hospital	Fargo	North Dakota	United States	58122
93	Children's Hospital Medical Center of Akron	Akron	Ohio	United States	44308-1062
94	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229-3039
95	Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106-5000
96	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195-5217
97	Columbus Children's Hospital	Columbus	Ohio	United States	43205-2696
98	Children's Medical Center - Dayton	Dayton	Ohio	United States	45404-1815
99	Toledo Hospital	Toledo	Ohio	United States	43606
100	Medical College of Ohio Cancer Institute	Toledo	Ohio	United States	43608
101	Oklahoma University Medical Center	Oklahoma City	Oklahoma	United States	73104
102	Cancer Institute at Oregon Health and Science University	Portland	Oregon	United States	97201-3098
103	Geisinger Medical Center	Danville	Pennsylvania	United States	17822-1320
104	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
105	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104-9786
106	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania	United States	19134
107	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213-2583
108	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425
109	Palmetto Health South Carolina Cancer Center	Columbia	South Carolina	United States	29203-6897
110	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota	United States	57117-5039
111	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6310
112	Texas Tech University Health Sciences Center School of Medicine	Amarillo	Texas	United States	79106
113	Children's Hospital of Austin	Austin	Texas	United States	78701
114	Driscoll Children's Hospital	Corpus Christi	Texas	United States	78411-1721
115	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390-9063
116	Covenant Children's Hospital	Lubbock	Texas	United States	79410
117	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78207
118	Methodist Children's Hospital of South Texas	San Antonio	Texas	United States	78229-3993
119	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
120	Primary Children's Medical Center	Salt Lake City	Utah	United States	84113-1100
121	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont	United States	05405
122	INOVA Fairfax Hospital	Fairfax	Virginia	United States	22031
123	Massey Cancer Center at Virginia Commonwealth University	Richmond	Virginia	United States	23298-0121
124	Carilion Cancer Center of Western Virginia	Roanoke	Virginia	United States	24029
125	Children's Hospital and Regional Medical Center - Seattle	Seattle	Washington	United States	98105
126	Providence Cancer Center at Sacred Heart Medical Center	Spokane	Washington	United States	99220-2555
127	Mary Bridge Children's Hospital and Health Center - Tacoma	Tacoma	Washington	United States	98405
128	Madigan Army Medical Center	Tacoma	Washington	United States	98431
129	West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division	Charleston	West Virginia	United States	25302
130	Cabell Huntington Hospital	Huntington	West Virginia	United States	25701
131	St. Vincent Hospital	Green Bay	Wisconsin	United States	54301
132	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin	United States	54601-5429
133	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-0001
134	Midwest Children's Cancer Center	Milwaukee	Wisconsin	United States	53226
135	Westmead Hospital	Westmead	New South Wales	Australia	2145
136	Office of S. David Lang	Herston, Brisbane	Queensland	Australia	4029
137	Princess Margaret Hospital for Children	Perth	Western Australia	Australia	6001
138	Alberta Children's Hospital	Calgary	Alberta	Canada	T2T 5C7
139	Children's & Women's Hospital of British Columbia	Vancouver	British Columbia	Canada	V6H 3V4
140	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
141	Janeway Children's Health and Rehabilitation Centre	St. John's	Newfoundland and Labrador	Canada	A1B 3V6
142	IWK Health Centre	Halifax	Nova Scotia	Canada	B3K 6R8
143	McMaster Children's Hospital at Hamilton Health Sciences	Hamilton	Ontario	Canada	L8N 3Z5
144	McGill Cancer Centre at McGill University	Montreal	Quebec	Canada	H3H 1P3
145	Hopital Sainte Justine	Montreal	Quebec	Canada	H3T 1C5
146	Centre Hospitalier Universitaire de Quebec	Ste-Foy	Quebec	Canada	G1V 4G2
147	San Jorge Children's Hospital	Santurce		Puerto Rico	00912
148	Swiss Pediatric Oncology Group Bern	Bern	Chihuahua	Switzerland	3010

Sponsors and Collaborators

• Children's Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Janet Franklin, MD, MPH, Children's Hospital Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

• Berman JN, Gerbing RB, Sung L, et al.: Prevalence and clinical implications of N-RAS mutations in childhood AML - A report from the Children's Oncology Group. [Abstract] Blood 114 (22): A-3115, 2009.
• Ho PA, Alonzo TA, Gerbing RB, Pollard J, Stirewalt DL, Hurwitz C, Heerema NA, Hirsch B, Raimondi SC, Lange B, Franklin JL, Radich JP, Meshinchi S. Prevalence and prognostic implications of CEBPA mutations in pediatric acute myeloid leukemia (AML): a report from the Children's Oncology Group. Blood. 2009 Jun 25;113(26):6558-66. doi: 10.1182/blood-2008-10-184747. Epub 2009 Mar 20.
• Ho PA, Alonzo TA, Kopecky KJ, Miller KL, Kuhn J, Zeng R, Gerbing RB, Raimondi SC, Hirsch BA, Oehler V, Hurwitz CA, Franklin JL, Gamis AS, Petersdorf SH, Anderson JE, Reaman GH, Baker LH, Willman CL, Bernstein ID, Radich JP, Appelbaum FR, Stirewalt DL, Meshinchi S. Molecular alterations of the IDH1 gene in AML: a Children's Oncology Group and Southwest Oncology Group study. Leukemia. 2010 May;24(5):909-13. doi: 10.1038/leu.2010.56. Epub 2010 Apr 8.
• Ho PA, Kopecky KJ, Alonzo TA, Gerbing RB, Miller KL, Kuhn J, Zeng R, Ries RE, Raimondi SC, Hirsch BA, Oehler V, Hurwitz CA, Franklin JL, Gamis AS, Petersdorf SH, Anderson JE, Godwin JE, Reaman GH, Willman CL, Bernstein ID, Radich JP, Appelbaum FR, Stirewalt DL, Meshinchi S. Prognostic implications of the IDH1 synonymous SNP rs11554137 in pediatric and adult AML: a report from the Children's Oncology Group and SWOG. Blood. 2011 Oct 27;118(17):4561-6. doi: 10.1182/blood-2011-04-348888. Epub 2011 Aug 26.
• Ho PA, Kuhn J, Gerbing RB, Pollard JA, Zeng R, Miller KL, Heerema NA, Raimondi SC, Hirsch BA, Franklin JL, Lange B, Gamis AS, Alonzo TA, Meshinchi S. WT1 synonymous single nucleotide polymorphism rs16754 correlates with higher mRNA expression and predicts significantly improved outcome in favorable-risk pediatric acute myeloid leukemia: a report from the children's oncology group. J Clin Oncol. 2011 Feb 20;29(6):704-11. doi: 10.1200/JCO.2010.31.9327. Epub 2010 Dec 28.
• Ho PA, Zeng R, Alonzo TA, Gerbing RB, Miller KL, Pollard JA, Stirewalt DL, Heerema NA, Raimondi SC, Hirsch B, Franklin JL, Lange B, Meshinchi S. Prevalence and prognostic implications of WT1 mutations in pediatric acute myeloid leukemia (AML): a report from the Children's Oncology Group. Blood. 2010 Aug 5;116(5):702-10. doi: 10.1182/blood-2010-02-268953. Epub 2010 Apr 22.
• Phillips CL, Gerbing R, Alonzo T, Perentesis JP, Harley IT, Meshinchi S, Bhatla D, Radloff G, Davies SM. MDM2 polymorphism increases susceptibility to childhood acute myeloid leukemia: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2010 Aug;55(2):248-53. doi: 10.1002/pbc.22519.
• Pollard J, Alonzo T, Gerbing R, et al.: Prevalence and prognostic significance of c-KIT mutations in pediatric CBF AML patients enrolled on serial CCG/COG protocols. [Abstract] Blood 110 (11): A-1442, 2007.
• Pollard JA, Alonzo TA, Gerbing RB, Ho PA, Zeng R, Ravindranath Y, Dahl G, Lacayo NJ, Becton D, Chang M, Weinstein HJ, Hirsch B, Raimondi SC, Heerema NA, Woods WG, Lange BJ, Hurwitz C, Arceci RJ, Radich JP, Bernstein ID, Heinrich MC, Meshinchi S. Prevalence and prognostic significance of KIT mutations in pediatric patients with core binding factor AML enrolled on serial pediatric cooperative trials for de novo AML. Blood. 2010 Mar 25;115(12):2372-9. doi: 10.1182/blood-2009-09-241075. Epub 2010 Jan 7.
• Pollard JA, Alonzo TA, Loken M, Gerbing RB, Ho PA, Bernstein ID, Raimondi SC, Hirsch B, Franklin J, Walter RB, Gamis A, Meshinchi S. Correlation of CD33 expression level with disease characteristics and response to gemtuzumab ozogamicin containing chemotherapy in childhood AML. Blood. 2012 Apr 19;119(16):3705-11. doi: 10.1182/blood-2011-12-398370. Epub 2012 Feb 29.
• Sung L, Alonzo TA, Gerbing RB, Aplenc R, Lange BJ, Woods WG, Feusner J, Franklin J, Patterson MJ, Gamis AS; Children's Oncology Group. Respiratory syncytial virus infections in children with acute myeloid leukemia: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2008 Dec;51(6):784-6. doi: 10.1002/pbc.21710.

• Responsible Party: Children's Oncology Group
• ClinicalTrials.gov Identifier: NCT00070174
• Other Study ID Numbers: AAML03P1; CDR0000330133; COG-AAML03P1
• First Posted: Oct 7, 2003
• Last Update Posted: Feb 20, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by Children's Oncology Group: untreated childhood acute myeloid leukemia and other myeloid malignancies; childhood acute monocytic leukemia (M5b); childhood acute megakaryocytic leukemia (M7); childhood acute minimally differentiated myeloid leukemia (M0); childhood acute myeloblastic leukemia with maturation (M2); childhood acute myeloblastic leukemia without maturation (M1); childhood acute myelomonocytic leukemia (M4); childhood acute monoblastic leukemia (M5a); childhood acute erythroleukemia (M6)
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Cytarabine; Cyclosporine; Cyclophosphamide; Busulfan; Methotrexate; Etoposide; Daunorubicin; Asparaginase; Mitoxantrone; Gemtuzumab; Cyclosporins

Study Results

No Results Posted as of Feb 20, 2014