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

Response Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663751
• Other study ID #: RJ-BMT-2018-1
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2018
• Est. completion date: March 1, 2021

Study information

• Verified date: May 2021
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Response Rate

Intervention

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

Locations

Country	Name	City	State
China	Blood & Marrow Transplantation Center, RuiJin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate	Documentation >98% donor chimerism of T cells or mononuclear cell in either peripheral blood or bone marrow	6 months after initiation of treatment
Secondary	relapse rate	Documentation of blast in bone marrow >5%	12 months after initiation of treatment
Secondary	engraftment failure	Documentation of pancytopenia with donor chimerism <5%	12 months after initiation of treatment
Secondary	survival rate	event counted as death due to any cause	12 months after initiation of treatment
Secondary	incidence of grade III-IV aGVHD	event counted as documentation of new onset or aggravation of pre-existing aGVHD into grade III-IV	12 months after initiation of treatment
Secondary	incidence of moderate to severe chronic GVHD	event counted as documentation of moderate to severe chronic GVHD	12 months after initiation of treatment
Secondary	Overall response	Documentation of complete or partial response	6 months after initiation of treatment