Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia
A Collaborative Trial for the Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia
2 other identifiers
interventional
238
1 country
8
Brief Summary
The purpose of this study is to compare the effectiveness of two multi-agent chemotherapy regimens using different dosages of cytarabine to eliminate all detectable leukemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2002
Longer than P75 for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 24, 2005
CompletedFirst Posted
Study publicly available on registry
August 26, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedResults Posted
Study results publicly available
March 26, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedDecember 5, 2012
November 1, 2012
5.9 years
August 24, 2005
March 5, 2010
November 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Minimal Residual Disease (MRD).
Detection of Minimal Residual Disease following one course of chemotherapy where positive MRD was defined as one or more leukemic cell per 1000 mononuclear bone-marrow cells (\>=0.1%).
Day 22 MRD measurement
Secondary Outcomes (6)
Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO)
Consolidation I
Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO
Induction II
Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO.
Induction II
To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy
Five Year
To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy
Measurements were assessed in Induction I chemotherapy
- +1 more secondary outcomes
Study Arms (2)
HDAC (High-Dose Cytarabine)
EXPERIMENTALSince limited characters are allowed in this passage, please see detailed Description for HDAC.
LDAC (Low-Dose Cytarabine)
EXPERIMENTALSince limited characters are allowed in this passage, please see detailed Description for LDAC.
Interventions
Since limited characters are allowed in this passage, please see detailed Description to know the dosage, dosage form, frequency of administration for the above mentioned drugs
Since limited characters are allowed in this passage, please see detailed Description to know the dosage, dosage form, frequency of administration for the above mentioned drugs
Eligibility Criteria
You may qualify if:
- Diagnosis of acute myeloid leukemia by immunophenotyping, morphology, and cytochemical staining; myelodysplasia; or biphenotypic leukemia.
- Age less than or equal to 21 years at time of study entry.
- No prior therapy for this malignancy (patients with secondary AML following treatment of primary malignancy are eligible) except for one dose of intrathecal therapy.
- Negative pregnancy test
- Patient does not have Down syndrome, acute promyelocytic leukemia (APL), or juvenile myelomonocytic leukemia (JMML)
You may not qualify if:
- Positive pregnancy test
- Down syndrome, acute promyelocytic leukemia (APL), or juvenile myelomonocytic leukemia (JMML)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Stanford University Medical Center
Palo Alto, California, 94304, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Children's Hospital of Michigan (Wayne State University)
Detroit, Michigan, 48201, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Children's Cancer Center
Houston, Texas, 77030, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Related Publications (3)
Elsayed AH, Rafiee R, Cao X, Raimondi S, Downing JR, Ribeiro R, Fan Y, Gruber TA, Baker S, Klco J, Rubnitz JE, Pounds S, Lamba JK. A six-gene leukemic stem cell score identifies high risk pediatric acute myeloid leukemia. Leukemia. 2020 Mar;34(3):735-745. doi: 10.1038/s41375-019-0604-8. Epub 2019 Oct 23.
PMID: 31645648DERIVEDGamazon ER, Lamba JK, Pounds S, Stark AL, Wheeler HE, Cao X, Im HK, Mitra AK, Rubnitz JE, Ribeiro RC, Raimondi S, Campana D, Crews KR, Wong SS, Welsh M, Hulur I, Gorsic L, Hartford CM, Zhang W, Cox NJ, Dolan ME. Comprehensive genetic analysis of cytarabine sensitivity in a cell-based model identifies polymorphisms associated with outcome in AML patients. Blood. 2013 May 23;121(21):4366-76. doi: 10.1182/blood-2012-10-464149. Epub 2013 Mar 28.
PMID: 23538338DERIVEDRubnitz JE, Inaba H, Dahl G, Ribeiro RC, Bowman WP, Taub J, Pounds S, Razzouk BI, Lacayo NJ, Cao X, Meshinchi S, Degar B, Airewele G, Raimondi SC, Onciu M, Coustan-Smith E, Downing JR, Leung W, Pui CH, Campana D. Minimal residual disease-directed therapy for childhood acute myeloid leukaemia: results of the AML02 multicentre trial. Lancet Oncol. 2010 Jun;11(6):543-52. doi: 10.1016/S1470-2045(10)70090-5. Epub 2010 May 5.
PMID: 20451454DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeffrey Rubnitz, M.D
- Organization
- St. Jude Children's Research Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Rubnitz, M.D., PhD
St. Jude Children's Research Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2005
First Posted
August 26, 2005
Study Start
August 1, 2002
Primary Completion
July 1, 2008
Study Completion
June 1, 2012
Last Updated
December 5, 2012
Results First Posted
March 26, 2010
Record last verified: 2012-11