ALL SCTped 2012 FORUM - Allogeneic Stem Cell Transplantation in Children and Adolescents with Acute Lymphoblastic Leukaemia

Phase 2/3

Not yet recruiting

• Conditions: Acute Lymphoblastic Leukaemia

• Registration Number: 2024-512657-24-00
• Lead Sponsor: St. Anna Childrens Cancer Research Institute GmbH

Brief Summary

Stratum 1 – randomised question (closed in December 2018, randomised patients 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) or an HLA matched donor (MD).

Stratum 1 – MSD/MD: 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 cohort (question 3 and 5).

Stratum 1 – MSD/MD in age-group 2-4 years: To explore incidence of adverse events of special interest (AESIs) and short-term overall survival and event free survival in the entire cohort receiving TBI/VP16 conditioning regimen.

Stratum 2 – MMD: To explore event free survival (EFS) after HSCT from HLA mismatched donors using mismatched unrelated donors (MMD), mismatched cord blood or HLA haplo-identical family members.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-09
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 1108

Inclusion Criteria

All patients with ALL (except for patients with mature B-ALL) who fulfil the following criteria:

Age at diagnosis ≤ 18 years OR age at HSCT ≤ 21 years

Indication for allogeneic HSCT

Complete remission (CR) before SCT

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

Whole protocol and/or its essential parts are refused either by the 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; renal impairment (< 30% of normal glomerular filtration rate); severe pulmonary, hepatic or cardiac impairment due to toxicity or infection

Karnofsky / Lansky score < 50%

Subjects unwilling or unable to comply with the study procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stratum 1: Overall Survival (OS)		Stratum 1: Overall Survival (OS)
Stratum 2: Event Free Survival (EFS)		Stratum 2: Event Free Survival (EFS)

Secondary Outcome Measures

Name	Time	Method
Stratum 1: EFS		Stratum 1: EFS
Stratum 2: OS		Stratum 2: OS
Stratum 1 and 2: Cumulative Incidence of Treatment-related mortality (TRM)		Stratum 1 and 2: Cumulative Incidence of Treatment-related mortality (TRM)
Stratum 1 and 2: Cumulative Incidence of Relapse		Stratum 1 and 2: Cumulative Incidence of Relapse
Stratum 1 and 2: Toxicity: acute and late		Stratum 1 and 2: Toxicity: acute and late
Stratum 1 and 2: Acute Graft versus Host Disease (aGVHD) and chronic GVHD (cGvHD)		Stratum 1 and 2: Acute Graft versus Host Disease (aGVHD) and chronic GVHD (cGvHD)
Stratum 1 and 2: Secondary malignancies		Stratum 1 and 2: Secondary malignancies

Trial Locations

Locations (61)

St. Anna Kinderspital GmbH; 🇦🇹 Vienna, Austria

Medical University Of Graz; 🇦🇹 Graz, Austria

Medizinische Universitaet Innsbruck; 🇦🇹 Innsbruck, Austria

Centre Hospitalier Universitaire De Liege; 🇧🇪 Liege, Belgium

Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Sint-Lambrechts-Woluwe, Belgium

Fakultni Nemocnice V Motole; 🇨🇿 Prague, Czechia

Rigshospitalet; 🇩🇰 Copenhagen Oe, Denmark

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St. Anna Kinderspital GmbH

🇦🇹Vienna, Austria

Herbert Pichler

Site contact

+431401703100

herbert.pichler@stanna.at