Low-dose Decitabine for the Treatment of Decreased Donor Chimerism After Allogeneic Stem Cell Transplantation

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT03663751
Collaborator
(none)
14
Enrollment
1
Location
1
Arm
32
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Decreasing donor chimerism is considered as an early sign of graft failure or relapse in patients undergoing allogeneic stem cell transplantation. The treatment option included tapering or stop of immunosuppression and or donor lymphocyte infusion (DLI) which may restore a full donor chimerism but subsequent graft versus host disease (GVHD) is the major complications. In this single arm prospective study, the investigator evaluate the effect and safety of low-dose decitabine alone or with DLI in patients with decreased donor chimerism after allo-HSCT.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Detailed Description

Decreasing donor chimerism is considered as an early sign of graft failure or relapse in patients undergoing allogeneic stem cell transplantation. The treatment option included tapering or stop of immunosuppression and or donor lymphocyte infusion (DLI) which may restore a full donor chimerism but subsequent GVHD is the major complications. In this single arm prospective study, the investigator plan to evaluate the effect and safety of low-dose decitabine treatment alone in patients with decreased donor chimerism after allo-HSCT. The investigators expect an overall response rate of 80% without serious toxicity such as grade III-IV aGVHD, ext cGVHD and lethal infection event associated with low-dose decitabine (LD-DAC) treatment. In case of donor chimerism decreasing, 5-day low-dose decitabine (5mg/m2) will given every 6 to 8 weeks until full donor chimerism is achieved (>98%). Fast withdraw of immuno-suppression or stop of immunosupression is not carried out in the study.

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pre-emptive Therapy With Low-dose Decitabine for Patients With Decreased Donor Chimerism After Allogeneic Stem Cell Transplantation
Actual Study Start Date :
Jul 1, 2018
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Treatment

The peripheral and bone marrow T cell and mono nucleated cell chimerism will be closely followed-up. In case of decreasing donor chimerism, patients will receive low-dose decitabine with 5mg/m2 daily for 5 days every 6-8 weeks until the chimerism recovered to full donor type (>98%).

Drug: Decitabine
low-dose decitabine: 5mg/m2 daily for 5 days
Other Names:
  • LD-DAC
  • Outcome Measures

    Primary Outcome Measures

    1. Complete response rate [6 months after initiation of treatment]

      Documentation >98% donor chimerism of T cells or mononuclear cell in either peripheral blood or bone marrow

    Secondary Outcome Measures

    1. relapse rate [12 months after initiation of treatment]

      Documentation of blast in bone marrow >5%

    2. engraftment failure [12 months after initiation of treatment]

      Documentation of pancytopenia with donor chimerism <5%

    3. survival rate [12 months after initiation of treatment]

      event counted as death due to any cause

    4. incidence of grade III-IV aGVHD [12 months after initiation of treatment]

      event counted as documentation of new onset or aggravation of pre-existing aGVHD into grade III-IV

    5. incidence of moderate to severe chronic GVHD [12 months after initiation of treatment]

      event counted as documentation of moderate to severe chronic GVHD

    6. Overall response [6 months after initiation of treatment]

      Documentation of complete or partial response

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • all patients after allogeneic stem cell transplantation

    • decreasing of donor chimerism to less than 97%

    • providing inform consent

    Exclusion Criteria:
    • patients with documented relapse disease

    • patients with documented positive MRD+ (>0.1% via flowcytometry or PCR)

    • patients with active infection or grade III-IV GVHD

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Blood & Marrow Transplantation Center, RuiJin HospitalShanghaiShanghaiChina200025

    Sponsors and Collaborators

    • Shanghai Jiao Tong University School of Medicine

    Investigators

    • Principal Investigator: Jiong HU, Department of Hematology, Rui jin Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jiong HU, Head, BMT program, Deputy director, Department of Hematology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT03663751
    Other Study ID Numbers:
    • RJ-BMT-2018-1
    First Posted:
    Sep 10, 2018
    Last Update Posted:
    May 21, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jiong HU, Head, BMT program, Deputy director, Department of Hematology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 21, 2021