Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation

Higher-risk Myelodysplastic Syndrome Clinical Trial

— DFMBHSCT  

Official title:

Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01806116
• Other study ID #: hematology-01
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 5, 2013
• Last updated: March 11, 2013
• Start date: September 2009
• Est. completion date: May 2014

Study information

• Verified date: March 2013
• Source: The First Affiliated Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Higher-risk Myelodysplastic Syndrome
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia
• Relapsed /Refractory Acute Myeloid Leukemia
• Syndrome

Intervention

Drug:
• decitabine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidences of acute and chronic graft-versus-host disease		three years	Yes
Primary	overall survival rates		three years	Yes
Secondary	disease free survival		three years	Yes