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Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia

NCT00469014 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-01-26

Study results available
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Summary

The goal of this clinical research study is to find the best dose of clofarabine and fludarabine that can be given with busulfan followed by an allogeneic blood stem cell transplant. Researchers will study whether this combination can help to control the disease, and look at the safety of this combination. Researchers also want to find out if combining busulfan with clofarabine alone or combining busulfan with both fludarabine and clofarabine will improve the treatment, compared with the previous standard method using busulfan and fludarabine alone.

Conditions

Interventions

DRUG

Clofarabine

Day -6 to Day -3 for Arm 1 = 10 mg/m\^2 intravenous (IV) Daily; Arm 2 = 20 mg/m\^2 IV Daily; Arm 3 = 30 mg/m\^2 IV Daily; Arm 4 = 40 mg/m\^2 IV Daily

DRUG

Busulfan

Day -6 to Day -3 for Arm 1: 30 mg/m\^2 IV Daily; Arm 2: 20 mg/m\^2 IV Daily; Arm 3: 10 mg/m\^2 IV Daily; Arm 4: 40 mg/m\^2 IV Daily. Test dose Day -8 32 mg/ m\^2 IV over 45 min, rest on Day -7.

DRUG

Fludarabine

Day -6 to Day -3 for Arm 1: 30 mg/m\^2 IV Daily; Arm 2: 20 mg/m\^2 IV Daily; Arm 3: 10 mg/m\^2 IV Daily

OTHER

Stem Cell Infusion

Day 0 stem cell infusion (Bone marrow or peripheral blood progenitor cells (PBPC))

DRUG

Thymoglobulin (ATG)

Day -3 to Day -1 at 0.5 mg/kg IV on Day -3; 1.5 mg/kg on Day -2 and 2.0 mg/kg on Day -1.

DRUG

Filgrastim

Subcutaneous injection daily, starting 1 week after Stem Cell Transplant.

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Richard E. Champlin, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT00469014 on ClinicalTrials.gov