NCT01949129

Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

Recruiting now Phase 2/Phase 3 Last updated 12 January 2024

What this trial tests

Phase 2/Phase 3 trial testing VP16 in Acute Lymphoblastic Leukaemia in 1,800 participants. Currently enrolling.

Timeline

1 April 2013

Primary endpoint
1 June 2025

1 April 2030

Quick facts

Lead sponsor	St. Anna Kinderkrebsforschung
Phase	Phase 2/Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,800
Start date	1 April 2013
Primary completion	1 June 2025
Estimated completion	1 April 2030
Sites	119 locations across Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, Croatia

Drugs / interventions tested

• VP16
• TBI
• Thiotepa — full drug profile →
• Treosulfan (TREOSULFAN) — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →
• Busulfan — full drug profile →
• ATG Thymoglobulin
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Grafalon

Conditions studied

• Acute Lymphoblastic Leukaemia — all drugs for Acute Lymphoblastic Leukaemia →

Sponsor

St. Anna Kinderkrebsforschung — full company profile →

Who can join

Adults 1 Month to 18, any sex, with Acute Lymphoblastic Leukaemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Overall Survival (OS) Stratum 1a (randomisation TBI+ chemo-conditioning vs. chemo-conditioning only)
  Time frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years
  Stratum 1 - randomisation related question was closed in December 2018; patients are in active follow-up: To show that a non total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu or Flu/Thio/Treo) results in a non-inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human leucocyte antigen (HLA) identical sibling donor (MSD
• Event free survival (EFS) Stratum 2 (mismatched donor transplantation)
  Time frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years
  EFS after allogeneic HSCT. EFS calculated from date of recruitment to disease progression or relapse, secondary neoplasm and death from any cause.
• Overall Survival (OS), Stratum 1b: MSD/MD without randomisation
  Time frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years
  To explore the impact of risk factors on the incidence of adverse events of special interest (AESIs) and on overall survival and event free survival in the entire MSD/MD cohort

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Indications for haematopoietic cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2022.
   Snowden JA, Sánchez-Ortega I, Corbacioglu S, Basak GW, et al · · 2022 · cited 235× · PMID 35589997 · DOI 10.1038/s41409-022-01691-w
2. Total Body Irradiation or Chemotherapy Conditioning in Childhood ALL: A Multinational, Randomized, Noninferiority Phase III Study.
   Peters C, Dalle JH, Locatelli F, Poetschger U, et al · · 2021 · cited 235× · PMID 33332189 · DOI 10.1200/jco.20.02529
3. The Role of Allogeneic Hematopoietic Stem Cell Transplantation in Pediatric Leukemia.
   Algeri M, Merli P, Locatelli F, Pagliara D. · · 2021 · cited 28× · PMID 34501237 · DOI 10.3390/jcm10173790
4. Treosulfan-fludarabine-thiotepa-based conditioning treatment before allogeneic hematopoietic stem cell transplantation for pediatric patients with hematological malignancies.
   Kalwak K, Mielcarek M, Patrick K, Styczynski J, et al · · 2020 · cited 24× · PMID 32203268 · DOI 10.1038/s41409-020-0869-6
5. Chimeric Antigen Receptor T-Cell Therapy in Paediatric B-Cell Precursor Acute Lymphoblastic Leukaemia: Curative Treatment Option or Bridge to Transplant?
   Buechner J, Caruana I, Künkele A, Rives S, et al · · 2021 · cited 20× · PMID 35145941 · DOI 10.3389/fped.2021.784024
6. Allogeneic Hematopoietic Stem Cell Transplantation for Children With Acute Lymphoblastic Leukemia: Shifting Indications in the Era of Immunotherapy.
   Truong TH, Jinca C, Mann G, Arghirescu S, et al · · 2021 · cited 13× · PMID 35004545 · DOI 10.3389/fped.2021.782785
7. Total body irradiation as part of conditioning regimens in childhood leukemia-long-term outcome, toxicity, and secondary malignancies.
   Gruen A, Exner S, Kühl JS, von Stackelberg A, et al · · 2022 · cited 10× · PMID 34282476 · DOI 10.1007/s00066-021-01810-4
8. Indications for haematopoietic cell transplantation and CAR-T for haematological diseases, solid tumours and immune disorders: 2025 EBMT practice recommendations.
   Greco R, Ruggeri A, McLornan DP, Snowden JA, et al · · 2025 · cited 9× · PMID 40926035 · DOI 10.1038/s41409-025-02701-3