Comparative Study of BFC and BuCy Conditioning Regimen for Allo-PBSCT in Acute B-cell ALL
Status:
Recruiting
Trial end date:
2025-12-30
Target enrollment:
Participant gender:
Summary
Comparing the efficacy and safety of fludarabine-containing BFC conditioning regimen with
traditional BuCy conditioning regimen in Acute B-cell lymphoblastic leukemia patients who
treated with allogeneic hematopoietic stem cell transplantation, to establish a conditioning
regimen for improving the survival rate of patients with B-cell ALL after transplantation.
Acute B-cell lymphoblastic leukemia (B-ALL) is a hematologic malignancy . The incidence of
B-All is higher in children than in adults, but more than 80% of children patients can be
cured by chemotherapy, while the survival rate of adult patients is less than 40%. Recurrence
or progression of the disease is the main reason affecting the survival of patients.
Although CD19-targeted CAR T cell therapy is an effective salvage treatment for relapsed and
refractory B-ALL, bridging allogeneic hematopoietic stem cell transplantation is required
after remission. 1-year LFS and 1-year OS were 11.6% and 32% in patients without bridging
grafts after CAR T.
Allogeneic hematopoietic stem cell transplantation is an effective treatment for ALL. Before
the transplant, patients receive high doses of chemotherapy plus or total body
irradiation（TBI） to 'creation of space' ，immunosuppression and disease eradication. This is
called conditioning regimen. Conditioning regimen plays a key role in reducing tumor load and
diseaseconditioning regimen recurrence.
Conditioning regimen for different diseases are different. Conditioning regimen are based on
TBI and chemotherapy BuCy, with low TBI recurrence rate but high treatment-related mortality
(TRM). BuCY chemotherapy had low TRM but high recurrence rate, so there was no difference in
total OS. Therefore, it is of great clinical value to explore a conditioning regimenprogram.
How to optimize the preconditioning program before transplantation, so as to reduce the
recurrence rate and prolong the survival period of adult B-cell ALL patients after
transplantation has become a issue that needs to be solved urgently in clinical practice.
BFC (Malilane + fludarabine + cyclophosphamide) is the addition of fludarabine to BuCy
(malilane + cyclophosphamide). The combination of fludarabine and cyclophosphamide has
synergistic effect, which can better kill B lymphocyte, and can enhance the killing effect of
pretreatment regimen on B lymphocyte tumor.
Phase:
Phase 4
Details
Lead Sponsor:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine