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Controlled Study of Post-transplant Azacitidine for Prevention of Acute Myelogenous Leukemia and Myelodysplastic Syndrome Relapse (VZ-AML-PI-0129)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00887068
First Posted: April 23, 2009
Last Update Posted: April 17, 2017
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.
Collaborator:
Celgene
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
The goal of this clinical research study is to learn if Vidaza (azacitidine) will help to control the disease in patients with AML, CMML, or MDS after an allogeneic (donor) stem cell transplant. The safety of this drug will also be studied.

Condition Intervention Phase
Leukemia AML MDS Drug: Azacitidine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study of Post-transplant Azacitidine for Prevention of Acute Myelogenous Leukemia and Myelodysplastic Syndrome Relapse (VZ-AML-PI-0129)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Relapse-free survival (RFS) Time [ Time Frame: 3, 6, and 12 months ]

    Goal is to test hypothesis that AZA provides at least a 50% improvement in m = median RFS, from 6 to 9 months. Complete response defined as bone marrow with < 6% blasts. Molecular studies of minimal residual disease not be required to define response.

    Secondary graft failure defined as a sustained decline of ANC below 0.5 x 109/L for 3 consecutive days after initial documented engraftment with no evidence of disease progression.



Enrollment: 187
Actual Study Start Date: April 21, 2009
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azacitidine
Azacitidine 32 mg/m^2 given through a needle under the skin for five consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles.
Drug: Azacitidine
32 mg/m^2 given through a needle under the skin for five consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles.
Other Names:
  • 5-Azacitidine
  • 5-aza
  • Vidaza
  • 5-AZC
  • AZA-CR
  • Ladakamycin
  • NSC-102816
No Intervention: No Azacitidine
Standard treatment post allogeneic transplant is supportive care only.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Patients with a diagnosis of AML (World Health Organization classification: >=20% blasts in the bone marrow and / or peripheral blood) or MDS (International Prognostic Scoring System intermediate-1 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 1 cycle of treatment to achieve the remission, or that have AML evolving from MDS, or that had the following abnormalities: FLT3 mutation, deletion of chromosome 5 or 7, MLL gene rearrangement, or more than or equal to 3 cytogenetics abnormalities. Patients with de novo or therapy-related MDS, CMML, or AML are also eligible, regardless of cytogenetics or molecular rearrangements.
  2. Biphenotypic Leukemia that at the time of allogeneic transplantation was in induction failure, relapsed disease, first, second or greater remission.
  3. Patients must be in complete remission post transplant.
  4. Patient may be enrolled 40 to 100 days after transplant.
  5. Age 18 to 75 years old.
  6. Serum creatinine < 1.8 mg/dL or creatinine clearance greater or equal than 40 cc/min as defined by the Cockcroft-Gault Equation*. a. Males(mL/min):(140-age)*IBW(kg) / 72*(serum creatinine(mg/dl)) b. Females(mL/min):0.85*(140-age)*IBW(kg) / 72*(serum creatinine(mg/dl)).
  7. Serum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome).
  8. SGPT </= 200 IU/ml unless related to patient's malignancy.
  9. Be able to understand and sign informed consent.

Exclusion Criteria:

  1. Active uncontrolled infection.
  2. Presence of uncontrolled graft-versus-host disease.
  3. Patients that underwent allogeneic transplantation as a treatment of graft failure.
  4. Pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is not post-menopausal with a positive serum pregnancy test.
  5. Known or suspected hypersensitivity to azacitidine or mannitol.
  6. Patients with advanced malignant hepatic tumors.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00887068


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene
Investigators
Principal Investigator: Richard E. Champlin, MD, BS M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00887068     History of Changes
Other Study ID Numbers: 2008-0503
NCI-2012-01259 ( Registry Identifier: NCI CTRP )
First Submitted: April 22, 2009
First Posted: April 23, 2009
Last Update Posted: April 17, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Acute myelogenous leukemia
AML
Myelodysplastic syndrome
MDS
Remission
Allogeneic stem cell transplant
Allotx
Azacitidine
5-Azacitidine
5-aza
Vidaza
5-AZC
AZA-CR
Ladakamycin
NSC-102816

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors