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FORUM2: Optimizing HSCT in Pediatric ALL
NCT07297914Phase 3
Key facts
- Status
- Recruiting
- Start
- Jan 2026
- Primary completion
- Nov 2032
- Countries
- 9
- Modality
- Antibody Conjugates, scFv Fragments, Monoclonal Antibodies
- Conditions
- acute lymphoblastic leukemia (ALL)graft-versus-host disease (GVHD)
01
Overview
Phase 3, randomised, open-label trial of ruxolitinib, blinatumomab and cyclophosphamide in acute lymphoblastic leukemia (ALL) and graft-versus-host disease (GVHD) (7 arms). Primary endpoints: Event Free Survival at 4 years, Overall Response Rate at 28 days and 1 more. Started Jan 2026; status: recruiting.
02
Design
7 arms- Study design
- RandomizedOpen-label
R1 substudy - TBI 8 Gy
Total Body Irradiation 8 Gy for conditioning
R1 substudy - TBI 12 Gy
Total Body Irradiation 12 Gy for conditioning
R2 substudy - Ruxolitinib + Corticosteroids
Ruxolitinib plus corticosteroids for treatment-naïve aGvHD
R2 substudy - Corticosteroids alone
Corticosteroids alone for treatment-naïve aGvHD
S1 substudy - Cyclophosphamide
In vivo T-cells depletion with post-transplant cyclophosphamide
S1 substudy - αβ T-cells depletion
Ex vivo αβ T-cells depletion
1 more in the full profile.
03
Who it enrols
Patients aged 3 months to 25 years with ALL in complete remission eligible for allogeneic HSCT, excluding those with severe organ dysfunction, active infections, or prior allogeneic HSCT (unless for specific post-transplant substudies).
04
Endpoints
Primary
Event Free Survival
Overall Response Rate
Cumulative Incidence of Relapse
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