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

NCT03663751 | Completed Phase 2

• 1 other identifier: RJ-BMT-2018-1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Response Rate

Keywords

donor chimerism,; decitabine,; allo-HSCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• relapse rate

  12 months after initiation of treatment

• engraftment failure

  12 months after initiation of treatment

• survival rate

  12 months after initiation of treatment

• incidence of grade III-IV aGVHD

  12 months after initiation of treatment

• incidence of moderate to severe chronic GVHD

  12 months after initiation of treatment

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

Decitabine DRUG

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

Also known as: LD-DAC

Treatment

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• all patients after allogeneic stem cell transplantation
• decreasing of donor chimerism to less than 97%
• providing inform consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Interventions

Decitabine

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Jiong HU

  Department of Hematology, Rui jin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, BMT program, Deputy director, Department of Hematology, Rui Jin Hospital

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: July 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)