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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00350818
Recruitment Status : Completed
First Posted : July 11, 2006
Last Update Posted : July 30, 2012
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Myelodysplastic Syndrome Leukemia Drug: Azacitidine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Azacitidine Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for AML and MDS
Study Start Date : October 2005
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: Azacitidine
Azacitidine after Allogeneic Transplantation
Drug: Azacitidine
8 mg/m^2 Subcutaneously Once Daily for 5 Days
Other Name: Vidaza

Primary Outcome Measures :
  1. Time to Toxicity [ Time Frame: Baseline with 30 day cycles (up to 4 cycles), approximately 116 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00350818

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
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Principal Investigator: Marcos de Lima, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00350818    
Other Study ID Numbers: 2005-0417
First Posted: July 11, 2006    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012
Keywords provided by M.D. Anderson Cancer Center:
Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Allogeneic Transplantation
Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors