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Decitabine Followed by Donor Lymphocyte Infusion for Patients With Relapsed Acute Myeloblastic Leukemia(AML) After Allogeneic Stem Cell Transplantation

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01758367
Collaborator
Navy General Hospital, Beijing (Other)
30
Enrollment
1
Location
1
Arm
66
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Decitabine can up-regulate a series of immune associated proteins, including cancer testis antigens (CTA), major histocompatibility complex (MHC), co-stimulatory molecules and adhesion molecules, which suggests a potential benefit for a following adoptive T cell therapy. In addition, decitabine induce FOXP3 expression in CD4+ T cells and convert CD4+ T cells into T regulatory cells(Tregs). As a result, Graft versus host disease(GVHD) can be reduced by treatment of decitabine.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Dec 1, 2012
Anticipated Primary Completion Date :
Jun 1, 2017
Anticipated Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Decitabine+DLI

Patients with relapsed AML after Allo-HSCT will be treated with decitabine and DLI.

Drug: Deciatbine(DAC)
Other Names:
  • 5-aza-2'-deoxycytidine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. complete remission rate [4 months]

    Secondary Outcome Measures

    1. overall survival [3 Years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 18 - 60 years

    • Histologically or cytologically documented relapse of acute myeloid leukemia after a stem cell 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

    • Must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 3

    • Must have suitable donor

    Exclusion Criteria:

    • Must not have an advanced malignant hepatic tumor

    • Must not receive any other forms of chemotherapy after cell infusion during the treatment protocol

    • Must not be receiving any other investigational agents within 14 days of first dose of study drug

    • 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 history of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine or other agents used in the study

    • Must not have a known or suspected hypersensitivity to decitabine

    • Must not be human immunodeficiency virus (HIV)-positive and on combination antiretroviral therapy; these patients are ineligible because of the potential for pharmacokinetic interactions with decitabine; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chinese PLA General Hospital Beijing Beijing China 100853

    Sponsors and Collaborators

    • Chinese PLA General Hospital
    • Navy General Hospital, Beijing

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Li Yu, Director of Department of Hematology, Chinese PLA General Hospital
    ClinicalTrials.gov Identifier:
    NCT01758367
    Other Study ID Numbers:
    • CN301-XYK-002
    First Posted:
    Jan 1, 2013
    Last Update Posted:
    Aug 31, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by Li Yu, Director of Department of Hematology, Chinese PLA General Hospital
    demethylating agent
    immunogenicity
    decitabine(DAC)
    donor lymphocyte infusion(DLI)
    AML
    Additional relevant MeSH terms:
    Leukemia
    Decitabine

    Study Results

    No Results Posted as of Aug 31, 2016