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NCT07297914: FORUM2
Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL
Phase 2, PHASE3 trial testing Total Body Irradiation 8 Gy in Acute Lymphoblastic Leukemia (ALL) in 1,000 participants. Not yet recruiting.
30 November 2032
Quick facts
| Lead sponsor | Bambino Gesù Hospital and Research Institute |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,000 |
| Start date | 15 January 2026 |
| Primary completion | 30 November 2032 |
| Estimated completion | 1 December 2032 |
| Sites | 9 locations across Denmark, France, Finland, Italy, Austria, Germany, Poland, Norway |
Drugs / interventions tested
- Total Body Irradiation 8 Gy
- Ruxolitinib
- Blinatumomab (blinatumomab) — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Total Body Irradiation 12 Gy
- Corticosteroids (corticosteroids) — full drug profile →
- αβ T-cells depletion
Conditions studied
- Acute Lymphoblastic Leukemia (ALL) — all drugs for Acute Lymphoblastic Leukemia (ALL) →
- Stem Cell Transplant — all drugs for Stem Cell Transplant →
- Graft -Versus-host-disease — all drugs for Graft -Versus-host-disease →
Sponsor
Bambino Gesù Hospital and Research Institute
Who can join
Adults 3 Months to 25, any sex, with Acute Lymphoblastic Leukemia (ALL) or Stem Cell Transplant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Current therapeutic strategies for high-risk or relapsed ALL patients often involve intensive treatments, including allogeneic hematopoietic stem cell transplantation (HSCT). HSCT remains a cornerstone of therapy, offering curative potential; however, it is associated with considerable risks, including non-relapse mortality (NRM), significant morbidity, and long-term complications that continue to be major concerns. In response to these challenges, the FORUM consortium has made substantial progress in improving outcomes for children with ALL undergoing HSCT. The consortium focuses on reducing life-threatening and lifelong complications, ultimately aiming to enhance quality of life for these high-risk patients. Building on the robust evidence generated by FORUM1, the FORUM2 study has been designed to further optimize the role of HSCT in ALL across all age groups and donor settings within a harmonized and internationally coordinated framework. The FORUM2 study introduces a master protocol structure that encompasses multiple hypothesis-driven substudies, each addressing a specific determinant of HSCT outcomes. This design enables simultaneous or sequential evaluation of novel strategies while ensuring uniform governance, endpoint definitions, and data-quality standards. The overarching objective is to refine the role of HSCT in ALL by reducing treatment-related toxicity while preserving the essential graft-versus-leukemia effect.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07297914
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Lymphoblastic Leukemia (ALL)
Currently open trials in the same condition.
- NCT07246213 — CAYA Cancer Retrospective Cohort Study · recruiting
- NCT05884333 — Cord Blood Transplant in Adults With Blood Cancers · Phase 2 · recruiting
- NCT03849651 — TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-ce · Phase 2 · active not recruiting
- NCT03590171 — International Study for Treatment of High Risk Childhood Relapsed ALL 2010 · Phase 2 · recruiting
- NCT02790515 — Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical · Phase 2 · active not recruiting
Other Bambino Gesù Hospital and Research Institute trials
Trials by the same sponsor.
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- NCT06080191 — Allogeneic Second-generation CD19-CAR T Cells for Pediatric Relapsed/Refractory B-ALL · Phase 1 · recruiting
- NCT06064903 — CD7-CAR-T Cells in Pediatric Relapsed/Refractory CD7+ T-ALL/LL · Phase 1, PHASE2 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07297914 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bambino Gesù Hospital and Research Institute
- Last refreshed: 22 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07297914.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing