Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT ID: NCT00814164
Last Updated: 2016-08-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
21 participants
INTERVENTIONAL
2008-12-31
2013-08-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Clorafarbine with daunorubicin
Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.
clofarabine
IV
daunorubicin hydrochloride
IV
cytogenetic analysis
Correlative study
protein expression analysis
Correlative Study
immunologic technique
Correlative Study
pharmacological study
Correlative Study
Interventions
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clofarabine
IV
daunorubicin hydrochloride
IV
cytogenetic analysis
Correlative study
protein expression analysis
Correlative Study
immunologic technique
Correlative Study
pharmacological study
Correlative Study
Eligibility Criteria
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Inclusion Criteria
PRIOR CONCURRENT THERAPY:
* No other concurrent systemic antileukemic therapy (standard or investigational)
* No concurrent cytotoxic therapy or investigational therapy
* No concurrent alternative medications (e.g., herbal or botanical for anticancer purposes)
* No prior chemotherapy
* Prior hydroxyurea allowed
60 Years
120 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Meir Wetzler, MD
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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RPCI-I-132208
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000630678
Identifier Type: -
Identifier Source: org_study_id
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