MedTrace Logo

Autologous Stem Cell Transplants for Chronic Myelogenous Leukemia

NCT00446173 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-08-25

No results posted yet for this study

Summary

Primary Objective:

1\. To study ex-vivo purging of autologous hematopoietic stem cells that will be used to support high-dose chemotherapy in patients with chronic myelogenous leukemia (CML). Major endpoints are neutrophil engraftment and survival.

Secondary Objectives:

1. To evaluate the toxicity of ex-vivo purged autologous cells when used to support high-dose chemotherapy.
2. To evaluate the rate and duration of cytogenetic remissions achieved with this strategy.
3. To determine the time to platelet recovery to 20,000/mm3.
4. To determine the one-year survival rate.

Conditions

Interventions

DRUG

Busulfan

130 mg/m\^2 IV Daily Over 3 Hours x 4 Days

DRUG

Cyclophosphamide

60 mg/kg IV Daily Over 4 Hours x 2 Days

DRUG

G-CSF

10 mcg/kg Subcutaneously Once Daily

DRUG

GM-CSF

250 mcg/kg Subcutaneously Once Daily

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Marcos de Lima, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-01-31
Completion
2009-01-31

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 NCT00446173 on ClinicalTrials.gov