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

This study is currently recruiting participants.

Verified by M.D. Anderson Cancer Center, August 2008

Sponsors and Collaborators:	M.D. Anderson Cancer Center Celgene Corporation
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00350818

Purpose

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

Secondary 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 I

MedlinePlus related topics: Bone Marrow Transplantation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Azacitidine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Azacitidine Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for AML and MDS

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

Primary Outcome Measures:

To find the safest combination of dose and schedule of administration of the drug 5-azacitidine (azacitidine, or Vidaza) that can be given to patients with AML and MDS after an allogeneic (donor) stem cell transplantation. [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The effectiveness of this treatment will also be studied. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	October 2005
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Azacitidine after Allogeneic Transplantation	Drug: Azacitidine 8 mg/m^2 Subcutaneously Once Daily for 5 Days

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Eligibility

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

Criteria

Inclusion:

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
Induction Failure, relapsed disease or second or greater remission.
Patients in first complete remission that required more than 2 cycles of treatment to achieve the remission.
Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or
HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch)
Age 18 to 75 years and
Left ventricular ejection fraction >40% and
FEV1, FVC and DLCO >40% and
Serum creatinine <1.6 mg/dL and
Serum bilirubin < 1.6 mg/dL and
SGPT < 3 X upper limit of normal and
All patients and donors or guardian should be able to understand and sign informed consent.
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:

HIV positive
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.)
Active uncontrolled infection
Pregnancy or breastfeeding

Contacts and Locations

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

Contacts

Contact: Marcos de Lima, MD

713-792-8750

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Marcos de Lima, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Celgene Corporation

Investigators

Principal Investigator:

Marcos de Lima, MD

U.T.M.D. Anderson Cancer Center

More Information

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Marcos de Lima, MD/Associate Professor )
Study ID Numbers:	2005-0417
Study First Received:	July 7, 2006
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00350818
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

Study placed in the following topic categories:

Myelodysplastic syndromes
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Myelodysplasia
Acute myelogenous leukemia
Leukemia, Myeloid

Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Azacitidine
Bone Marrow Diseases
Acute myelocytic leukemia

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Pathologic Processes
Disease
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Syndrome
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009