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

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

Interventions

DRUG

VP16

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

RADIATION

TBI

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

DRUG

Thiotepa

2x5 mg/kg BW, 1 day

DRUG

Treosulfan

14g/m² BS, 3 days

DRUG

Fludarabine

30 mg/m² BS, 5 days

DRUG

Busulfan

iV, dosage according therapeutic drug monitoring, 4 days

DRUG

ATG Thymoglobulin

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

DRUG

Cyclophosphamide

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

DRUG

Grafalon

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

Sponsors & Collaborators

• ALL SCTped Forum

  collaborator OTHER

• European Society for Blood and Marrow Transplantation

  collaborator NETWORK

• ALL-BFM Study Group

  collaborator NETWORK

• Assistance Publique - Hôpitaux de Paris

  collaborator OTHER

• Dutch Childhood Oncology Group

  collaborator OTHER

• Swiss Pediatric Oncology Group

  collaborator OTHER

• Australian & New Zealand Children's Haematology/Oncology Group

  collaborator OTHER

• St. Anna Kinderkrebsforschung

  lead OTHER

Principal Investigators

• Christina Peters, Prof. MD PhD · St. Anna Kinderspital, Vienna, Austria

• Peter Bader, Prof. MD PhD · Goethe University

• Franco Locatelli, Prof. MD PhD · Ospedale Pediatrico Bambino Gesù, Rome, Italy

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2025-06-30

Completion

2030-04-30

Countries

• Argentina
• Australia
• Austria
• Belarus
• Belgium
• Canada
• Chile
• Croatia
• Czechia
• Denmark
• Finland
• France
• Germany
• Greece
• Hungary
• Israel
• Italy
• Malaysia
• Mexico
• Netherlands
• New Zealand
• Norway
• Poland
• Romania
• Saudi Arabia
• Slovakia
• Slovenia
• Spain
• Sweden
• Switzerland
• Turkey (Türkiye)

Study Locations