Response Rate
Conditions
Keywords
donor chimerism,, decitabine,, allo-HSCT
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.
Interventions
DRUGDecitabine
low-dose decitabine: 5mg/m2 daily for 5 days
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate | 6 months after initiation of treatment | Documentation \>98% donor chimerism of T cells or mononuclear cell in either peripheral blood or bone marrow |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| engraftment failure | 12 months after initiation of treatment | Documentation of pancytopenia with donor chimerism \<5% |
| survival rate | 12 months after initiation of treatment | event counted as death due to any cause |
| relapse rate | 12 months after initiation of treatment | Documentation of blast in bone marrow \>5% |
| incidence of moderate to severe chronic GVHD | 12 months after initiation of treatment | event counted as documentation of moderate to severe chronic GVHD |
| Overall response | 6 months after initiation of treatment | Documentation of complete or partial response |
| incidence of grade III-IV aGVHD | 12 months after initiation of treatment | event counted as documentation of new onset or aggravation of pre-existing aGVHD into grade III-IV |
Countries
China
Outcome results
None listed