NCT00814164

Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

A Phase II Study Evaluating Mechanisms of Resistance Following Treatment With Clofarabine and Daunorubicin in Newly Diagnosed Adult Acute Myeloid Leukemia Patients > or = to 60 Years Old

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 60 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as clofarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving clofarabine together with daunorubicin may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving clofarabine together with daunorubicin works in treating older patients with newly diagnosed acute myeloid leukemia.

Detailed description

OBJECTIVES: Primary * Study complete response (CR) and CR without platelet recovery (CRp) following treatment with clofarabine and daunorubicin hydrochloride in older patients with newly diagnosed acute myeloid leukemia. Secondary * Study disease-free and overall survival of these patients following treatment with this regimen. * Compare disease-free and overall survival of patients whose cells do or do not demonstrate apoptosis following treatment with this regimen. OUTLINE: * Induction therapy: Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5. Patients are assessed after induction course 1. Patients with ≥ 5% blasts in bone marrow may receive another course of induction therapy beginning between 28-84 days after initiation of course 1. Patients who achieve complete remission (CR) or CR without platelet recovery (CRp) (after 1 or 2 courses of induction therapy) proceed to consolidation therapy. * Consolidation therapy: Beginning between 28 -84 days after initiation of last course of induction therapy, patients receive clofarabine IV over 1 hour on days 1-3 and daunorubicin hydrochloride IV over 5 minutes on days 1 and 3. Patients may receive a second course of consolidation therapy beginning between 28-84 days of consolidation course 1. Blood and bone marrow samples are collected periodically to assess response and for pharmacokinetic, cytogenetic, immunophenotyping, and molecular analyses. After completion of study treatment, patients are followed for at least 2 years.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	clofarabine	IV
DRUG	daunorubicin hydrochloride	IV
GENETIC	cytogenetic analysis	Correlative study
GENETIC	protein expression analysis	Correlative Study
OTHER	immunologic technique	Correlative Study
OTHER	pharmacological study	Correlative Study

Timeline

• Start date: 2008-12-01
• Primary completion: 2013-06-01
• Completion: 2013-08-01
• First posted: 2008-12-24
• Last updated: 2016-08-17
• Results posted: 2016-08-17

Locations

1 site across 1 country: United States