Clinical trial · Interventional
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
NCT01949129CI-TRIAL-00126023recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen. The stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukaemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATG Thymoglobulin | Drug | — | UNRESOLVED |
| Busulfan | Drug | Busulfan | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Grafalon | Drug | — | UNRESOLVED |
| TBI | Radiation | — | UNRESOLVED |
| Thiotepa | Drug | Thiotepa | ALIAS |
| Treosulfan | Drug | Treosulfan | ALIAS |
| VP16 | Drug | Etoposide |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Flu/Thio/Treo
- description
- Fludarabine/Thiotepa/Treosulfan is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients with: * MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon. * MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon. * MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide
- interventionNames
- Drug: Thiotepa
- Drug: Treosulfan
- Drug: Fludarabine
- Drug: ATG Thymoglobulin
- Drug: Grafalon
- type
- ACTIVE_COMPARATOR
- label
- TBI/VP16
- description
- TBI (Total Body Irradiation) / VP16 is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients older than 48 months with: * MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon. * MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon. * MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide. Patients aged 24-48 months may optionally receive Total Body Irradiation (TBI).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients with ALL (except for patients with B-ALL) who fulfil the following criteria: * age at diagnosis ≤ 18 years. Age at HSCT ≤ 21 years * indication for allogeneic HSCT * complete remission (CR) before HSCT * written consent of the parents (legal guardian) and, if necessary, the minor patient via "Informed Consent Form" * no pregnancy * no secondary malignancy * no previous HSCT * HSCT is performed in a study participating centre Exclusion Criteria: * patients who do not fulfil the inclusion criteria * Non Hodgkin-Lymphoma * the whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian * no consent is given for saving and propagation of anonymous medical data for study reasons * severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders) * Karnofsky / Lansky score \< 50% * subjects unwilling or unable to comply with the study procedures
References
Publications (10)
- DERIVEDBen Hassine K, Gloor Y, Dupanloup I, Uppugunduri CRS, Mlakar V, Gonzales F, Gungor T, Ifversen M, Shaw PJ, Buechner J, Truong TH, Bittencourt H, Teague L, Toporski J, Sedlacek P, Poetschger U, Krajinovic M, Kalwak K, Balduzzi A, Algeri M, Bader P, Peters C, Dalle JH, Ansari M. Refining busulfan exposure enhances pediatric ALL HSCT outcomes: insights from the International FORUM study. Blood Adv. 2026 May 26;10(10):3719-3730. doi: 10.1182/bloodadvances.2025019142. PMID 41779961
- DERIVEDBuechner J, Poetschger U, Bader P, Yesilipek A, Pichler H, Palma J, Staciuk R, Riha P, Krivan G, Ifversen M, Gungor T, Goussetis E, Kalwak K, Toporski J, Gabriel M, Renard M, Diaz-de-Heredia C, Matic T, Calkoen FG, Svec P, Meisel R, Balduzzi A, Locatelli F, Peters C, Dalle JH, Stein J. Outcomes of BCP-ALL with hypodiploidy or BCR::ABL1 fusion in children undergoing allogeneic HSCT: results from the FORUM study. Blood. 2026 Mar 19;147(12):1365-1379. doi: 10.1182/blood.2025030951. PMID 41259231
- DERIVEDGreco R, Ruggeri A, McLornan DP, Snowden JA, Alexander T, Angelucci E, Averbuch D, Bazarbachi A, Hazenberg MD, Kalwak K, Kenyon M, Mekelenkamp H, Neven B, Pedrazzoli P, Peric Z, Risitano AM, Sanchez-Ortega I, Ciceri F, Sureda A. Indications for haematopoietic cell transplantation and CAR-T for haematological diseases, solid tumours and immune disorders: 2025 EBMT practice recommendations. Bone Marrow Transplant. 2025 Nov;60(11):1499-1525. doi: 10.1038/s41409-025-02701-3. Epub 2025 Sep 9. PMID 40926035
- DERIVEDBalduzzi A, Glogova E, Peters C, Sedlacek P, Dalle JH, Locatelli F, Meisel R, Burkhardt B, Buechner J, Wachowiak J, Bierings M, Staciuk R, Graphakos S, Gungor T, Yesilipek A, Svec P, Palma J, Krivan G, Diaz-de-Heredia C, Limido F, Ansari M, Kalwak K, Bader P, Ifversen M. Impact of minimal residual disease on the outcome of hematopoietic stem cell transplantation for childhood acute lymphoblastic leukemia within the FORUM trial. Haematologica. 2026 Jan 1;111(1):122-134. doi: 10.3324/haematol.2025.287456. Epub 2025 Aug 7. PMID 40820816
- DERIVEDKalwak K, Moser LM, Potschger U, Bader P, Kleinschmidt K, Meisel R, Dalle JH, Yesilipek A, Balduzzi A, Krivan G, Goussetis E, Staciuk R, Sedlacek P, Pichler H, Svec P, Gabriel M, Gungor T, Bilic E, Buechner J, Renard M, Vettenranta K, Ifversen M, Diaz-de-Heredia C, Stein J, Toporski J, Bierings M, Peters C, Ansari M, Locatelli F. Comparable outcomes after busulfan- or treosulfan-based conditioning for allo-HSCT in children with ALL: results of FORUM. Blood Adv. 2025 Feb 25;9(4):741-751. doi: 10.1182/bloodadvances.2024014548.