Azacitidine Maintenance Therapy After Allogeneic Bone Marrow Transplantation (Allo BMT)

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00350818
First received: July 7, 2006
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

Primary Objective:

-To determine the dose and schedule combination of 5-Azacitidine, when used as maintenance treatment after allogeneic transplantation for high-risk AML / MDS.

Secondary Objective:

-To assess the effect of treatment on survival after allogeneic transplantation for high-risk AML / MDS.


Condition Intervention Phase
Myelodysplastic Syndrome
Leukemia
Drug: Azacitidine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Azacitidine Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for AML and MDS

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Time to Toxicity [ Time Frame: Baseline with 30 day cycles (up to 4 cycles), approximately 116 days ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: October 2005
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azacitidine
Azacitidine after Allogeneic Transplantation
Drug: Azacitidine
8 mg/m^2 Subcutaneously Once Daily for 5 Days
Other Name: Vidaza

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a diagnosis of AML (WHO classification: >=20% blasts in the bone marrow and / or peripheral blood), or MDS (IPSS intermediate-2 or higher) that at the time of allogeneic transplantation were in.
  2. Induction Failure, relapsed disease or second or greater remission.
  3. Patients in first complete remission that required more than 2 cycles of treatment to achieve the remission.
  4. Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or
  5. HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch)
  6. Age 18 to 75 years and
  7. Left ventricular ejection fraction >40% and
  8. FEV1, FVC and DLCO >40% and
  9. Serum creatinine <1.6 mg/dL and
  10. Serum bilirubin < 1.6 mg/dL and
  11. SGPT < 3 X upper limit of normal and
  12. All patients and donors or guardian should be able to understand and sign informed consent.
  13. Women of childbearing potential (any female who has experienced menarche, and who has not undergone surgical sterilization or is not post-menopausal) must have a negative serum pregnancy test.

Exclusion Criteria:

  1. HIV positive
  2. AML or MDS in first complete remission (defined as: bone marrow with less than 6% blasts, no circulating blasts, and a platelet count greater than 100,000 /mm^3.)
  3. Active uncontrolled infection
  4. Pregnancy or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350818

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
Principal Investigator: Marcos de Lima, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00350818     History of Changes
Other Study ID Numbers: 2005-0417
Study First Received: July 7, 2006
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Allogeneic Transplantation
Leukemia
Azacitidine
Vidaza

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Precancerous Conditions
Azacitidine
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014