Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00136084
First received: August 24, 2005
Last updated: November 2, 2012
Last verified: November 2012
Results First Received: March 5, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia, Myelocytic, Acute
Interventions: Drug: Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone
Drug: Etoposide, Cytarabine, Gemtuzumab, L-asparaginase, Mercaptopurine, methotrexate, Mitoxantrone, Prednisone, Vincristine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
238 patients were recruited between October, 2002 and June, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
238 patients were enrolled on the study. This report is based on results for 223 patients. 15 patients were excluded for the following reasons: 7 were switched to lymphoid-directed therapy shortly after enrollment, 6 were determined to be ineligible shortly after enrollment (wrong diagnosis), and 2 were not randomized.

Reporting Groups
  Description
Arm 1: (HDAC) High-dose Cytarabine (HDAC)
Arm 2:(LDAC) Low-dose Cytarabine (LDAC)

Participant Flow:   Overall Study
    Arm 1: (HDAC)     Arm 2:(LDAC)  
STARTED     109     114  
COMPLETED     61     72  
NOT COMPLETED     48     42  
Death                 12                 5  
Unacceptable toxicity                 8                 11  
Relapse                 20                 23  
Lost to Follow-up                 2                 0  
No Response                 1                 2  
Withdrawal by Subject                 5                 1  



  Baseline Characteristics


  Outcome Measures
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1.  Primary:   Minimal Residual Disease (MRD).   [ Time Frame: Day 22 MRD measurement ]

2.  Secondary:   Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO)   [ Time Frame: Consolidation I ]

3.  Secondary:   Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO   [ Time Frame: Induction II ]

4.  Secondary:   Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO.   [ Time Frame: Induction II ]

5.  Secondary:   To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy   [ Time Frame: Five Year ]

6.  Secondary:   To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy   [ Time Frame: Measurements were assessed in Induction I chemotherapy ]

7.  Secondary:   Relationship of Inhibition of DNA Synthesis and Clinical Response   [ Time Frame: Measurements were assessed in Induction I chemotherapy ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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