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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2021-03-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Response Rate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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%).

Group Type EXPERIMENTAL

Decitabine

Intervention Type DRUG

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

Interventions

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Decitabine

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

Intervention Type DRUG

Other Intervention Names

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LD-DAC

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No