Busulfan-Based Versus TBI-Based Conditioning for Adult ALL-CR2 Allo-HSCT

Condition(s) studied

Investigational drug(s) / intervention(s)

Chemotherapy-based Conditioning Regimen: Experimental Arm (Chemotherapy-based conditioning): Busulfan 0.8 mg/kg q.i.d. day -8 to -6; cyclophosphamide 1.8 g/m²/day day -5, -4; semustine 250 mg/m² day -3. For haploidentical transplant recipients: rabbit-ATG 2.5 mg/kg/day day -5 to -2.

TBI-based conditioning: Active Comparator Arm (TBI-based conditioning): Total-body irradiation 770 cGy on day -6; cyclophosphamide 1.8 g/m²/day day -5, -4; semustine 250 mg/m² day -3. For haploidentical transplant recipients: rabbit-ATG 2.5 mg/kg/day day -5 to -2.

Study summary

This is an multicenter, non-inferiority randomized controlled trial. Adult patients (14-65 years) with acute lymphoblastic leukemia in second complete remission (CR2) scheduled for allogeneic hematopoietic stem-cell transplantation (allo-HSCT) will be randomized 1:1 to receive either busulfan-based chemotherapy-only conditioning (experimental arm) or total-body-irradiation (TBI)-based conditioning (active comparator arm). The primary objective is to test the non-inferiority of chemotherapy-based conditioning versus TBI-based conditioning regarding 1-year leukemia-free survival (LFS). Secondary endpoints include treatment-related mortality (TRM), cumulative incidence of relapse (CIR), graft-versus-host-disease (GVHD), and overall survival (OS). All patients receive uniform GVHD prophylaxis and post-transplant supportive care.

Eligibility

Primary outcome measure(s)

• 1-Year Leukemia-Free Survival (LFS) — 12 months post-hematopoietic stem-cell infusion]
  Time from stem-cell infusion to leukemia relapse or death from any cause, whichever occurs first.

Trial sites (1)

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