A Novel Conditioning Regimen for Haplo-HSCT in Older Patients With SAA
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-60
SponsorPeking University People's Hospital
About this trial
The goal of this prospective, multicenter, single arm observational study is to evaluate the efficacy and safety of the BFCA regimen in ≥ 40 years old SAA patients undergoing haplo-HSCT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Severe aplastic anemia;
Aged 40-60 years old;
Weight 45Kg-100Kg;
Eastern Cooperative Oncology Group (ECOG) score ≤3;
Disqualifiers
With other hematologic diseases;
Expected survival of less than 1 month;
Previous autologous or allogeneic hematopoietic stem cell transplantation;
Pregnant patients;
Trial population
Patients aged 40-60 years old who are diagnosed with severe aplastic anemia according to NCCN guidelines and who will receive haploidentical hematopoietic stem cell transplantation at the centers will be recruited.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
BFCA conditiong regimen
Drugbusulfan 0.8 mg/kg/6h (days -8 to -7), fludarabine 30mg/m2/day (days -6 to -2), cyclophosphamide 25 mg/kg/day (days -5 to -2) and antithymocyte globulin(ATG) 2.5 mg/kg/day (days -5 to -2).
Treatment groups
64 Participants
are divided into 4 treatment groupsGroup A: Peking unviversity Peoples' Hospital1 intervention
Group B: The First Affiliated Hospital of Soochow University1 intervention
Group C: Guangzhou First People's Hospital,1 intervention
Group D: The First Affiliated Hospital of USTC1 intervention
Trial outcomes
Primary outcomes
1
Faliure free survival (FFS)
survival with a response to therapy after HSCT. Death, graft faliue and relapse were considered as treatment failure.
Time frame
From enrollment to 2 years post-HSCTSecondary outcomes
1
The probability of Overall survival
Overall survival was defined as the time from transplantation to death from any cause or to the last follow-up
Time frame
From enrollment to 2 years post-HSCT2
Myeloid and platelet engraftment
Myeloid and platelet engraftment were defined as international criteria.
Time frame
100 days post HSCT3
The incidence of mixed chimerism
The mixed chimerism was defined as the presence of 5%-95% donor haematopoietic cells.
Time frame
1 year post HSCT4
The incidence of graft versus host disease(GVHD)
The severity of acute and chronic GVHD was evaluated according to standard criteria.
Time frame
100 days post HSCT for aGvHD and 2 years post HSCT for cGvHDSponsors and contacts
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Source ClinicalTrials.gov