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NCT Number: NCT03663751

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

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.

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Key information

Conditions

Response Rate

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, Shanghai Municipality, 200025, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

decitabine

Drug

low-dose decitabine: 5mg/m2 daily for 5 days

Other names: LD-DAC

Primary outcomes

  1. Complete response rate

    Time frame: 6 months after initiation of treatment

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

Secondary outcomes

  1. relapse rate

    Time frame: 12 months after initiation of treatment

    Documentation of blast in bone marrow >5%

  2. engraftment failure

    Time frame: 12 months after initiation of treatment

    Documentation of pancytopenia with donor chimerism <5%

  3. survival rate

    Time frame: 12 months after initiation of treatment

    event counted as death due to any cause

  4. incidence of grade III-IV aGVHD

    Time frame: 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

    Time frame: 12 months after initiation of treatment

    event counted as documentation of moderate to severe chronic GVHD

  6. Overall response

    Time frame: 6 months after initiation of treatment

    Documentation of complete or partial response

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Pre-emptive Therapy With Low-dose Decitabine for Patients With Decreased Donor Chimerism After Allogeneic Stem Cell Transplantation

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Sep 10, 2018
Registry last updated
May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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