A Phase 1 interventional study of asparaginase and cytarabine in Leukemia and Myelodysplastic Syndromes, sponsored by Children's Oncology Group. Completed at 76 sites in 3 countries. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2014-02-20.
Sponsored by Children's Oncology Group · Phase 1, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with combination chemotherapy may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combining gemtuzumab ozogamicin with combination chemotherapy in treating children who have relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study of gemtuzumab ozogamicin. Patients are assigned by cohort to 1 of 2 treatment regimens.
Cohorts of 3-6 patients receive de-escalating doses of gemtuzumab ozogamicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose below that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 6 months, every 2 months for 6 months, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 1.5 years.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 47 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of primary acute myeloid leukemia (AML) or myelodysplastic syndromes
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Event Free Survival
Time frame: Length of study
Toxicity
Toxicity will be monitored through study chair notification and end course reports
Remission Rate
The remission rate in each arm will be estimated by the proportion of patients who achieved remission among patients who received GMTZ at the MTD level.
Time frame: Length of study
Prognostic Factor Analysis
The predictive value of the likelihood of leukemia blast cells to undergo apoptosis and drug resistance of leukemia blast cells will be assessed by logistic regression
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Children's Oncology Group