Randomized Allogeneic Azacitidine Study
This study is currently recruiting participants.
Verified November 2013 by M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: April 22, 2009
Last updated: November 4, 2013
Last verified: November 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Randomized Controlled Study of Post-transplant Azacitidine for Prevention of Acute Myelogenous Leukemia and Myelodysplastic Syndrome Relapse
Primary Outcome Measures:
- Relapse-free survival (RFS) Time [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2015 (Final data collection date for primary outcome measure)
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.
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.
No Intervention: No Azacitidine
Standard treatment post allogeneic transplant is supportive care only.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- Biphenotypic Leukemia that at the time of allogeneic transplantation was in induction failure, relapsed disease, first, second or greater remission.
- Patients must be in complete remission post transplant.
- Patient may be enrolled 40 to 100 days after transplant.
- Age 18 to 75 years old.
- 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)).
- Serum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome).
- SGPT </= 200 IU/ml unless related to patient's malignancy.
- Be able to understand and sign informed consent.
- Active uncontrolled infection.
- Presence of uncontrolled graft-versus-host disease.
- Patients that underwent allogeneic transplantation as a treatment of graft failure.
- 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.
- Breast feeding or pregnancy. Pregnancy means a positive beta HCG test in a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- Known or suspected hypersensitivity to azacitidine or mannitol.
- Patients with advanced malignant hepatic tumors.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887068
|Contact: Richard E. Champlin, MD, BS
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Richard E. Champlin, MD, BS
||UT MD Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 22, 2009
||November 4, 2013
||United States: Institutional Review Board
Keywords provided by M.D. Anderson Cancer Center:
Acute myelogenous leukemia
Allogeneic stem cell transplant
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Bone Marrow Diseases
Molecular Mechanisms of Pharmacological Action