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

NCT01806116 | Unknown Phase 4

• 1 other identifier: hematology-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Higher-risk Myelodysplastic Syndrome; Relapsed /Refractory Acute Myeloid Leukemia

Keywords

myelodysplastic syndrome; higher-risk; acute myeloid leukemia; relapsed /refractory; decitabine; hematopoietic cell transplantation; bridge therapy

Outcome Measures

Primary Outcomes (1)

• overall survival rates

  three years

Secondary Outcomes (1)

• disease free survival

  three years

Other Outcomes (1)

• The incidences of acute and chronic graft-versus-host disease

  three years

Study Arms (1)

decitabine + transplantation

EXPERIMENTAL

Drug: decitabine

Interventions

decitabine DRUG

decitabine + transplantation

Eligibility Criteria

• Age: 8 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Wu depei, Phd

  First Affiliated Hospital, Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 7, 2013
• Study Start: September 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2014
• Last Updated: March 12, 2013

Record last verified: 2013-03