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

NCT00350818 | Completed Phase 1

• 1 other identifier: 2005-0417
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelodysplastic Syndrome; Leukemia

Keywords

Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Allogeneic Transplantation; Leukemia; Azacitidine; Vidaza

Outcome Measures

Primary Outcomes (1)

• Time to Toxicity

  Baseline with 30 day cycles (up to 4 cycles), approximately 116 days

Study Arms (1)

Azacitidine

EXPERIMENTAL

Azacitidine after Allogeneic Transplantation

Drug: Azacitidine

Interventions

Azacitidine DRUG

8 mg/m\^2 Subcutaneously Once Daily for 5 Days

Also known as: Vidaza

Azacitidine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia; Leukemia, Myeloid, Acute

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Marcos de Lima, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2006
• First Posted: July 11, 2006
• Study Start: October 1, 2005
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

US (1)