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Azacitidine After Allo Blood And Marrow Transplantation (BMT) for Chronic Myelogenous Leukemia (CML)

NCT00813124 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-02-11

Study results available
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Summary

The goal of this clinical research study is to learn if Vidaza (azacitidine) when given to patients with CML after an donor stem cell transplant will increase the likelihood of achieving a complete remission of CML.

Conditions

Interventions

DRUG

Fludarabine

40 mg/m\^2 by vein over 60 minutes on Day -5 through Day -2.

DRUG

Busulfan

Busulfan administered at the dose calculated to achieve an area under curve (AUC) of 4000 µMol-min + 12% based on the pharmacokinetic studies (days -5, -4, -3, and -2).

DRUG

Thymoglobulin

2.5 mg/kg by vein over about 4-6 hours on Day -3 through Day -1.

DRUG

Azacitidine

Start cycles of 32 mg/m\^2 daily as an injection under the skin once a day over 5 days in a row, starting about 5 weeks after the transplant. This may be repeated once a month for up to 4 months after the transplant.

PROCEDURE

Stem Cell Transplant

Stem cell infusion on day 0 administered by vein after collected from donor.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Celgene Corporation

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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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 NCT00813124 on ClinicalTrials.gov