Clinical trial NCT03663751: Low-dose Decitabine for the Treatment of Decreased Donor Chimerism After Allogeneic Stem Cell Transplantation
Official title: Pre-emptive Therapy With Low-dose Decitabine for Patients With Decreased Donor Chimerism After Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Response Rate
Keywords: donor chimerism,
decitabine,
allo-HSCT
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 14
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complete response rate
timeFrame: 6 months after initiation of treatment
Secondary outcomes:
measure: relapse rate
timeFrame: 12 months after initiation of treatment
measure: engraftment failure
timeFrame: 12 months after initiation of treatment
measure: survival rate
timeFrame: 12 months after initiation of treatment
measure: incidence of grade III-IV aGVHD
timeFrame: 12 months after initiation of treatment
measure: incidence of moderate to severe chronic GVHD
timeFrame: 12 months after initiation of treatment
measure: Overall response
timeFrame: 6 months after initiation of treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Blood & Marrow Transplantation Center, RuiJin Hospital
state: Shanghai
Study officials:
affiliation: Department of Hematology, Rui jin Hospital
name: Jiong HU
role: PRINCIPAL_INVESTIGATOR
References: