Phase 2
N=24
Azacitidine After Allo Blood And Marrow Transplantation (BMT) for Chronic Myelogenous Leukemia (CML)
Stem Cell Transplantation · Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00813124 ↗Enrolled (actual)
24
Serious AEs
58.3%
Results posted
Jan 2021
Primary outcome: Primary: Number of Participants With Molecular Response — 8; 0; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fludarabine (Drug); Busulfan (Drug); Thymoglobulin (Drug); Azacitidine (Drug); Stem Cell Transplant (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Molecular Response |
8; 0; 4 | — |
Summary
The goal of this clinical research study is to learn if Vidaza (azacitidine) when given to patients with CML after an donor stem cell transplant will increase the likelihood of achieving a complete remission of CML.
Eligibility Criteria
Inclusion Criteria
- Patients with age 40%.
- Pulmonary function test within the following parameters: forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) => 50% of expected, corrected for hemoglobin.
- Serum creatinine 1L.
- HIV-positive.
- Breast feeding or pregnancy. Pregnancy means a positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Known or suspected hypersensitivity to azacitidine or mannitol.
- Patients with advanced malignant hepatic tumors.
Data sourced from ClinicalTrials.gov (NCT00813124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.