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

Primary Purpose

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

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
decitabine
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Higher-risk Myelodysplastic Syndrome focused on measuring myelodysplastic syndrome, higher-risk, acute myeloid leukemia, relapsed /refractory, decitabine, hematopoietic cell transplantation, bridge therapy

Eligibility Criteria

8 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    decitabine + transplantation

    Arm Description

    Outcomes

    Primary Outcome Measures

    overall survival rates

    Secondary Outcome Measures

    disease free survival

    Full Information

    First Posted
    March 5, 2013
    Last Updated
    March 11, 2013
    Sponsor
    The First Affiliated Hospital of Soochow University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01806116
    Brief Title
    Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation
    Acronym
    DFMBHSCT
    Official Title
    Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2009 (undefined)
    Primary Completion Date
    March 2013 (Anticipated)
    Study Completion Date
    May 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital of Soochow University

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    decitabine + transplantation
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    decitabine
    Primary Outcome Measure Information:
    Title
    overall survival rates
    Time Frame
    three years
    Secondary Outcome Measure Information:
    Title
    disease free survival
    Time Frame
    three years
    Other Pre-specified Outcome Measures:
    Title
    The incidences of acute and chronic graft-versus-host disease
    Time Frame
    three years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wu depei, Phd
    Organizational Affiliation
    First Affiliated Hospital, Soochow University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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