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Autologous Transplantation for Chronic Myelogenous Leukemia

NCT01003054 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-11-02

No results posted yet for this study

Summary

The goal of this clinical research is to learn if treatment with high-dose busulfan and cyclophosphamide plus autologous bone marrow transplantation followed by treatment with Gleevec (imatinib mesylate) is effective in treating chronic myelogenous leukemia (CML).

Objectives:

1. To assess the efficacy of high dose busulfan-cyclophosphamide and autologous hematopoietic transplantation with post transplant Imatinib mesylate for the treatment of CML. The primary endpoint of the study is to determine the proportion of patients with CML alive in cytogenetic remission at one year following this treatment.
2. Secondary endpoints are time to progression and survival.

Conditions

  • Chronic Myelogenous Leukemia

Interventions

DRUG

Busulfan

130 mg/m\^2 in normal saline over three (3) hours IV every twenty-four (24) hours for four (4) consecutive days (days -7 to -4)

DRUG

Cyclophosphamide

60 mg/kg in 500 ml of normal saline over 4 hours on each of 2 consecutive days (day -3, -2)

DRUG

Imatinib Mesylate

Starting dose 100 mg/day (mg/d), escalated to maximal dose of 400 mg/d as tolerated, after day 28 when Absolute neutrophil count (ANC) is \>1500/mcl and platelets \>50,000 /mcl, may be titrated to maintain ANC \>1.0 and platelets \>50,000 /mcl.

PROCEDURE

Autologous Stem Cell Transplantation

Stem Cell Infusion: Unpurged hematopoietic stem cells administered intravenously on day 0.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Marcos de Lima, MD · UT MD Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2007-12-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT01003054 on ClinicalTrials.gov