Phase 3
N=223
Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia
Leukemia, Myelocytic, Acute
Bottom Line
View on ClinicalTrials.gov: NCT00136084 ↗Enrolled (actual)
223
Serious AEs
18.8%
Results posted
Mar 2010
Primary outcome: Primary: Minimal Residual Disease (MRD). — 31; 43; 68; 63 participants — p=.1559
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone (Drug); Etoposide, Cytarabine, Gemtuzumab, L-asparaginase, Mercaptopurine, methotrexate, Mitoxantrone, Prednisone, Vincristine (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- St. Jude Children's Research Hospital
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minimal Residual Disease (MRD). |
31; 43; 68; 63 | .1559 |
| SECONDARY Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO) |
11; 4 | — |
| SECONDARY Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO |
27; 2 | — |
| SECONDARY Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO. |
27; 3 | — |
| SECONDARY To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy |
62.4 | — |
| SECONDARY To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy |
60.6; 72.8 | 0.60 |
| SECONDARY Relationship of Inhibition of DNA Synthesis and Clinical Response |
66.7 | 0.2287 |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- Positive pregnancy test
- Down syndrome, acute promyelocytic leukemia (APL), or juvenile myelomonocytic leukemia (JMML)
Data sourced from ClinicalTrials.gov (NCT00136084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.