NCT00602225

Clofarabine, Cytarabine, and G-CSF in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Dose Escalation Study of Clofarabine in Combination With Cytarabine (Ara-C) and G-CSF Priming for Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: 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 stopping them from dividing. Colony stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine to see how well it works when given together with cytarabine and G-CSF in treating patients with relapsed or refractory acute myeloid leukemia

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of clofarabine, and the dose-limiting toxicities of the combination of clofarabine and cytarabine with G-CSF priming, in the treatment of patients with relapsed or refractory AML. SECONDARY OBJECTIVES: I. To determine the hematological and non-hematological side effect profile of the combination of clofarabine, cytarabine, and G-CSF. II. To determine the efficacy of clofarabine in combination with cytarabine and G-CSF priming in the treatment of patients with relapsed or refractory AML. III. To determine the disease-free and overall survival after therapy with clofarabine, cytarabine, and G-CSF for relapsed or refractory AML. OUTLINE: This is a dose escalation study of clofarabine. PART I: INDUCTION THERAPY: Patients receive clofarabine IV over 1 hour and cytarabine IV over 2 hours on days 1-5, and filgrastim (G-CSF) subcutaneously once daily beginning 24 hours prior to chemotherapy and continuing until blood count recover. Patients with residual leukemia (\>= 5% blasts by morphology) at day 14 and if blast remain \> 5% by day 21 receive a second course of induction therapy. CONSOLIDATION THERAPY: Patients receive clofarabine, cytarabine, and G-CSF as in induction therapy. Patients may receive a second course of consolidation therapy depending on response and whether additional therapy (e.g., stem cell transplant or donor lymphocyte infusion) is planned. PARTS II and III: Patients receive induction therapy and consolidation therapy as in part 1. After completion of study treatment, patients are followed every 3 months for 2 years and then annually for 3 years.

Conditions

• Acute Myeloid Leukemia
• Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
• Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
• Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
• Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
• Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
• Adult Acute Promyelocytic Leukemia (M3)
• Recurrent Adult Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	clofarabine	Given IV
DRUG	cytarabine	Given IV
BIOLOGICAL	filgrastim	Given subcutaneously

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-03-01
• Completion: 2015-04-01
• First posted: 2008-01-28
• Last updated: 2018-03-09
• Results posted: 2017-09-08

Locations

1 site across 1 country: United States