A Phase 1/2 interventional study of clofarabine and cytarabine in Leukemia and Myelodysplastic Syndromes, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Status unknown at 10 sites in 5 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-07-20.
Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 1/2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as clofarabine, cytarabine, and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of clofarabine and to see how well it works when given together with cytarabine and idarubicin in treating patients with intermediate-risk or high-risk acute myeloid leukemia or high-risk myelodysplasia.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, phase I, dose-escalation study of clofarabine followed by an randomized phase II study. Patients are stratified according to center, and presence of poor prognostic features (WBC at diagnosis ≥ 100,000/μL vs presence of very high risk cytogenetic features -5/5q-, -7/7q-, presence of complex abnormalities [> 3 abnormalities], 3q, t[6;9], or t[9;22]). Patients are randomized to 1 of 2 treatment arms.
Induction therapy:
After completion of study therapy, patients are followed periodically for 12 months.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 114 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.
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DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following by WHO criteria:
Acute myeloid leukemia (AML) (≥ 20% bone marrow blasts by bone marrow aspiration or biopsy)
All cytogenetic groups allowed, except for the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Patients receive idarubicin IV over 5 minutes on days 1, 3, and 5, cytarabine IV continuously on days 1-10, and clofarabine IV over 1 hour on days 2, 4, 6, 8, and 10.
Drug: clofarabine · Drug: cytarabine · Drug: idarubicin
Patients receive idarubicin IV and cytarabine IV as in arm I. Patients also receive clofarabine IV by push injection over 10 minutes on days 2, 4, 6, 8, and 10.
Drug: clofarabine · Drug: cytarabine · Drug: idarubicin
Given IV
Given IV
Given IV
Toxicity as assessed by CTCAE v3.0 (Phase I)
Response rate (Phase II)
Toxicity as assessed by CTCAE v3.0 (Phase II)
Response rate (Phase I)
Duration of survival
Duration of survival from complete remission (CR)/CR with incomplete hematopoietic recovery (CRi) rate
Disease-free survival from CR/CRi
Incidence of relapse and incidence of death in CR/CRi
This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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European Organisation for Research and Treatment of Cancer - EORTC