NCT05379569

Comparative Study of BFC and BuCy Conditioning Regimen for Allo-PBSCT in Acute B-cell ALL

Status unknown Phase 4 Last updated 18 May 2022

What this trial tests

Phase 4 trial testing Fludarabine in Acute B Lymphoblastic Leukemia in 142 participants. Status unknown.

Timeline

15 May 2022

Primary endpoint
30 November 2023

30 December 2025

Quick facts

Lead sponsor	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	142
Start date	15 May 2022
Primary completion	30 November 2023
Estimated completion	30 December 2025
Sites	1 location across China

Drugs / interventions tested

• Fludarabine (FLUDARABINE) — full drug profile →

Conditions studied

• Acute B Lymphoblastic Leukemia — all drugs for Acute B Lymphoblastic Leukemia →
• Allogeneic Hematopoietic Stem Cell Transplantation — all drugs for Allogeneic Hematopoietic Stem Cell Transplantation →

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Who can join

Adults 18 to 55, any sex, with Acute B Lymphoblastic Leukemia or Allogeneic Hematopoietic Stem Cell Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.