Expired Study
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Tampa, Florida 33612


Purpose:

The purpose of this study is to find out if treating people who have high-risk myelodysplastic syndrome (MDS) with Vidaza (also called 5-azacitidine) prior to their allogeneic hematopoietic cell transplant (HCT) is helpful in preventing their myelodysplastic syndrome from coming back. In previous research, Vidaza appeared to help the bone marrow of a patient with MDS begin to function more normally. This means bone marrow cells can grow and do their work the way they were meant to. Vidaza is approved by the Food and Drug Administration (FDA) for the treatment of MDS. The effect of Vidaza in patients receiving hematopoietic cell transplants have not been studied.


Study summary:

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 Vidaza will be given per standard practice. - Vidaza 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 Vidaza 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 Vidaza 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 Vidaza. - As the number of cycles of Vidaza is not standardized and the retrospective review of our patients noted above indicated a benefit to ANY exposure to Vidaza, the actual number of cycles of Vidaza 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 Vidaza before transplant, or after the fourth cycle of Vidaza, 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.


Criteria:

Inclusion Criteria: - Potential candidate for HCT. - Histologically confirmed diagnosis by pathologic review of previous diagnosis of high-risk myelodysplastic syndrome (MDS): International Prognostic Scoring System (IPSS) > 1 or AML-MDS or treatment related MDS. - Serum bilirubin levels ≤1.5 times the upper limit of the normal (ULN) range for the laboratory. Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis; Serum glutamic-oxaloacetic transaminase (SGOT) [aspartate aminotransferase (AST)] or serum glutamicpyruvic transaminase (SGPT) [alanine aminotransferase (ALT)] levels ≤2 x ULN. - Serum creatinine levels ≤1.5 x ULN - Karnofsky performance status greater or equal to 70% - Signed informed consent form in accordance with institutional policies Exclusion Criteria: - Known or suspected hypersensitivity to Vidaza or mannitol - Pregnant or lactating women - Human immunodeficiency virus (HIV) or seropositive, confirmed by nucleic acid amplification testing (NAT) - Active central nervous system (CNS) malignancy - Active infection - History or presence of primary hepatoma


NCT ID:

NCT00660400


Primary Contact:

Principal Investigator
Teresa Field, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute


Backup Contact:

N/A


Location Contact:

Tampa, Florida 33612
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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