A Pilot Study Of Pre-Transplant 5-Azacitidine (Vidaza) In Patients With High-Risk Myelodysplastic Syndrome (MDS) Who Are Candidates For Allogeneic Hematopoietic Cell Transplantation
5-azacitidine
+ Allogeneic Hematopoietic Cell Transplantation (HCT)
Hematologic Diseases+2
+ Hemic and Lymphatic Diseases
+ Leukemia
Treatment Study
Summary
Study start date: March 1, 2008
Actual date on which the first participant was enrolled.RESEARCH PLAN * This will be a single-center prospective trial * Patients with high risk MDS that are potentially eligible for HCT will be enrolled. * A donor search will be initiated, and 5-Azacitidine will be given per standard practice. * 5-Azacitidine dose is 75 mg/M\^2/day subcutaneously by standard practice (generally this is 7 days per monthly cycle, but alterations occur depending on clinical and laboratory parameters). * Patients where a suitable donor is not found can continue with 5-Azacitidine per standard treatment. These patients will be followed until progression of MDS to acute myelogenous leukemia (AML) or death, for up to one year. * If a suitable donor is obtained, the patient will proceed to HCT. The HCT conditioning regimen will be dictated by the Blood and Marrow Transplant (BMT) physician. While waiting HCT, additional cycles 5-Azacitidine may be given. Pre-HCT conditioning regimen therapy will begin no more than 8 weeks and no less than 4 weeks after the last administration of 5-Azacitidine. * As the number of cycles of 5-Azacitidine is not standardized and the retrospective review of our patients noted above indicated a benefit to ANY exposure to 5-Azacitidine, the actual number of cycles of 5-Azacitidine delivered will not be specified. In addition, as high risk MDS patients have an average time to death of 0.4 years, any delay to HCT once it is available is to be avoided. * A bone marrow biopsy will be performed to reassess disease response to therapy after the last cycle of 5-Azacitidine before transplant, or after the fourth cycle of 5-Azacitidine, whichever comes first. Note that both the biopsy and the timing of the biopsy is a standard evaluation procedure. * Donor progenitor cell collection will be prescribed by the BMT Attending Physician. HCT * The patient will undergo HCT designated per attending BMT physician. * Supportive care will be based on institutional guidelines, Stem cell collections, processing and laboratory studies Stem cell collections, processing and laboratory studies * Graft assessment, processing, and characterization will be done as per institutional guidelines * Chimerism testing will be obtained to document post-transplant engraftment, per standard practice.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 68 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
H. Lee Moffitt Cancer Center & Research Institute
Tampa, United StatesOpen H. Lee Moffitt Cancer Center & Research Institute in Google Maps