Overview

This trial is active, not recruiting.

Conditions higher-risk myelodysplastic syndrome, relapsed /refractory acute myeloid leukemia
Treatment decitabine
Phase phase 4
Sponsor The First Affiliated Hospital of Soochow University
Start date September 2009
End date March 2013
Trial size 30 participants
Trial identifier NCT01806116, hematology-01

Summary

Allogeneic stem cell transplantation (SCT) is the only potentially curative therapy for patients with myelodysplastic syndrome (MDS) and acute myeloblastic leukemia (AML). Relapse remains a leading cause for treatment failure after hematopoietic cell transplantation (HCT) in patients,so that there is the need to continue to look for alternative therapies. Decitabine, is known to inhibit DNA methyltransferase which results in DNA hypomethylation and expression of silenced genes including those involved in apoptosis. The approval of decitabine for the treatment of MDS and AML has provided an alternative strategy to inhibit disease progression in transplant-eligible patients. To assess the effect of pretransplant decitabine treatment on post transplant outcomes, we recently reviewed our institutional experience with MDS and AML patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
decitabine

Primary Outcomes

Measure
overall survival rates
time frame: three years

Secondary Outcomes

Measure
disease free survival
time frame: three years

Eligibility Criteria

Male or female participants from 8 years up to 65 years old.

Inclusion Criteria: - Age 8- 65 years - Diseases must be myelodysplastic syndrome and acute myelocytic leukemia - Must need a bone marrow transplant - Must have the ability to observe the efficacy and events - Patient must have ability to understand and willingness to provide written informed consent prior to participation in the study and any related procedures being performed Exclusion Criteria: - Must not have uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements - Must not be pregnant or breastfeeding; pregnant women are excluded from this study because decitabine is a Category D agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with decitabine, breastfeeding should be discontinued if the mother is treated with decitabine; these potential risks may also apply to other agents used in this study - Must not have a known or suspected hypersensitivity to decitabine

Additional Information

Official title Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation
Principal investigator Wu depei, Phd
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by The First Affiliated Hospital of Soochow University.