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Decitabine Based Chemotherapy Followed by Haploidentical Lymphocyte Infusion for Elderly Patients With AML

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02662647
Collaborator
Navy General Hospital, Beijing (Other)
30
Enrollment
1
Location
2
Arms
47
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory molecules and adhesion molecules. The leukemias cells treated by decitabine will become more sensitive to the following adoptive T cell therapy.We proposed a hypothesis that decitabine-based chemotherapy acts in synergestic with haploidentical lymphocyte infusion in eliciting leukemia specific cytotoxic lymphocyte(CTL) and diminishing leukemic cells.

Condition or Disease Intervention/Treatment Phase
  • Drug: Decitabine 20 mg/m²/day for 5 days
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Mar 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: DCAG plus HLI

Patient will be treated with decitabine and modified CAG regimen followed by HLA haploidentical peripheral mononuclear blood cells infusion.

Drug: Decitabine 20 mg/m²/day for 5 days
Other Names:
  • Cytarabine
  • aclacinomycin

    		•
    Experimental: DCAG

    Patient will be treated with decitabine combining modified CAG regimen without other treatments.

    Drug: Decitabine 20 mg/m²/day for 5 days
    Other Names:
  • Cytarabine
  • aclacinomycin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. complete remission(CR) rate [3 months]

    Secondary Outcome Measures

    1. overall survival [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Must have a diagnosis of AML based on 2008 World Health Organization (WHO) classification of myeloid malignancies

    • Must have life expectancy >= 3 months

    • Must have the ability to observe the efficacy and events

    • Must have no accompany therapy(including steroid)

    • 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 haploidentical donor

    DONOR Inclusion Criteria:

    • Must have signed the standard informed consent form; if sufficient cryopreserved cells remain from a previous donation, no additional donation or consent is required

    • Both men and women and members of all races and ethnic groups are eligible for this trial

    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

    DONOR Exclusion Criteria:

    • Must not have any underlying conditions which would contra-indicate apheresis

    • Must not be pregnant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Navy General Hospital Beijing Beijing China 100048

    Sponsors and Collaborators

    • Chinese PLA General Hospital
    • Navy General Hospital, Beijing

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Li-Xin Wang, MD. PH.D, Chinese PLA General Hospital
    ClinicalTrials.gov Identifier:
    NCT02662647
    Other Study ID Numbers:
    • ChinaNGH-H001
    First Posted:
    Jan 25, 2016
    Last Update Posted:
    Jun 10, 2019
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Li-Xin Wang, MD. PH.D, Chinese PLA General Hospital
    demethylating agent
    lymphocyte infusion
    Additional relevant MeSH terms:
    Cytarabine
    Decitabine
    Aclacinomycins

    Study Results

    No Results Posted as of Jun 10, 2019