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Clofarabine Combinations in Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS) and Myeloid Blast Phase Chronic Myeloid Leukemia (CML)

NCT00067028 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2020-12-08

Study results available
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Summary

The goal is to compare the drug combinations clofarabine/idarubicin/ara-C, clofarabine/ara-C, and clofarabine/idarubicin in the treatment of patients with Acute Myeloid Leukemia, high-grade MDS, or myeloid blast phase of Chronic Myeloid Leukemia who have relapsed following their initial therapy.

Conditions

Interventions

DRUG

Clofarabine 40mg/m^2

40 mg/m\^2 by vein over 1 hour daily for 5 days.

DRUG

Idarubicin 10mg/m^2

10 mg/m\^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle. Clofarabine + Idarubicin plus Ara-C: 6 mg/m\^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle.

DRUG

Ara-C 0.75 g/m^2

0.75 g/m\^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle.

DRUG

Clofarabine 22.5mg/m^2

22.5 mg/m\^2 by vein over 1 hour daily for 5 days.

DRUG

Ara-C 1 g/m^2

1 g/m\^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle.

DRUG

Idarubicin 6 mg/m^2

6 mg/m\^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle.

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Stefan H Faderl, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00067028 on ClinicalTrials.gov