Recruiting
Phase 2
Phase 3

Allogeneic Stem Cell Transplantation

Sponsor:

St. Anna Kinderkrebsforschung

Code:

NCT01949129

Conditions

Acute Lymphoblastic Leukaemia

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

VP16

TBI

Thiotepa

Treosulfan

Fludarabine

Study Details

Brief summary:

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

Acute Lymphoblastic Leukaemia

Study ID

NCT01949129

Start date

Apr, 2013

Status verified date

Jan, 2024

Completion date

Apr, 2030

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1800 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Flu/Thio/Treo

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

active comparator: TBI/VP16

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).

experimental: Flu/Thio/ivBu

Fludarabine/Thiotepa/iV Busulfan 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

experimental: Bu/VP16/Cy

Busulfan/VP16/Cyclophosphamide is an alternative conditioning arm that may optionally be used for HSCT with MSD/MD and MMD graft in patients aged 0-24 months. Patients undergoing MD HSCT will also receive ATG Thymo- or Grafalon.

Interventions

VP16

60 mg/kg BW,1 day in TBI/VP16 conditioning; 40 mg/kg BW in Bu/VP16/Cy conditioning

TBI

2 x 2Gy/day , 3 days (total 12Gy)

Thiotepa

2x5 mg/kg BW, 1 day

Treosulfan

14g/m² BS, 3 days

Fludarabine

30 mg/m² BS, 5 days

Busulfan

iV, dosage according therapeutic drug monitoring, 4 days

ATG Thymoglobulin

MD: ATG Thymo: 2,5mg/kg BW/d 3 days.

Cyclophosphamide

as part of conditioning 60 mg/kg BW 2 days or as GvHD Prophylaxis 50mg/kg BW/d 2 days with Mesna

Grafalon

MD: 15mg/kg BW/d 3 days MMD: 10mg/kg BW/d 3 days

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Christina Peters, Prof. MD PhD

+43140170christina.peters@stanna.at

Tijana Frank, MD, MScEng

+43140470tijana.frank@ccri.at

Locations

CHU Sainte-Justine Hematology-Oncology Division

Recruiting

Montreal, Canada

Contacts

Henrique Bittencourt, MD PhD

henrique.bittencourt.hsj@ssss.gouv.qc.ca

Principal Investigator:

Henrique Bittencourt, MD PhD

Hospital for Sick Children University of Toronto Division of Haematology/Oncology

Recruiting

Toronto, Canada

Contacts

Donna Wall, MD PhD

donna.wall@sickkids.ca

Principal Investigator:

Donna Wall, MD PhD

BC Children's Hospital

Recruiting

Vancouver, Canada

Contacts

Kirk Schultz, MD PhD

kschultz@mail.ubc.ca

Principal Investigator:

Kirk Schultz, MD PhD

More Information

Sponsor

St. Anna Kinderkrebsforschung

Last update posted

Jan 16, 2024

Last verified

Jan, 2024

Keywords

  • stem cell transplantation
  • children and adolescents
  • high risk acute lymphoblastic leukaemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Anna Kinderkrebsforschung on 2024-01-16.