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Clofarabine and Cytarabine in Treating Young Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia


A Phase I/II Study of CLOLAR® (Clofarabine, IND# 73, 789) in Combination With Cytarabine in Pediatric Patients With Refractory/Relapsed Leukemia


Drugs used in chemotherapy, such as clofarabine and cytarabine, 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.


This phase I/II trial is studying the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating young patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia. (Phase I closed to enrollment as of 09/16/09)

Study Status: Active, not recruiting


Condition Intervention Phase
Leukemia Drug: clofarabine
Drug: cytarabine
Drug: methotrexate
Other: laboratory biomarker analysis
Phase 1/Phase 2

Verified by Children`s Oncology Group December, 2013

Sponsored by: Children`s Oncology Group
Information provided by: Children`s Oncology Group identifier: NCT00372619

Study Type: Interventional

Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States

Bassem I. Razzouk, MD., Study Chair
Todd Cooper, DO., Study Chair

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