ALL-SCT BFM International- HSCT in Children and Adolescents With ALL

Summary

With this protocol the ALL-SCT BFM international study group wants

* to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD).
* to evaluate the efficacy of hematopoietic stem cell transplantation (HSCT)from mismatched family or unrelated donors (MMD) as compared to HSCT from matched sibling donors or matched donors.
* to determine whether therapy has been carried out according to the main HSCT protocol recommendations. The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only.
* to prospectively evaluate and compare the incidence of acute and chronic Graft-versus-Host-Disease (GvHD) after HSCT from matched sibling donor (MSD), from matched donor (MD) and from mismatched donor (MMD).

Conditions

• Lymphoblastic Leukemia, Acute, Childhood;

Interventions

DRUG

VP16

patients with MSD receive as conditioning VP16 60mg/kg/d on day -3

RADIATION

TBI

patients with a MSD receive TBI (12Gy in 6 fractions) as conditioning

DRUG

VP16, ATG

patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive VP16 60mg/kg/d on day -3 and ATG fresenius 20mg/kg/d on day -3,-2,-1

RADIATION

TBI

patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive TBI (12Gy in 6 fractions)

DRUG

Fludarabine, OKT3, Treosulfan, Thiotepa

patients with a MMD (haploidentical or cord blood) receive Fludarabine 30mg/m²/d on day -9 to -5, ATG fresenius 20mg/kg/d on day -3,-2,-1, Treosulfan 14g/m²/d on day -7 to -5 and Thiotepa 2x5mg/kg/d on day -4

DRUG

VP16, ATG

patients with MMD-transplantation (8/10)receive VP16 60mg/kg/d on day -4, ATG from day -3 to day-1 20mg/kg/d

RADIATION

TBI

patients with a MMD-transplantation (8/10) receive 12 Gy in 6 fractions

Sponsors & Collaborators

• St. Anna Kinderkrebsforschung

  lead OTHER

Principal Investigators

• Christina Peters Peters, Prof MD PHD · St. Anna Kinderkrebsforschung

• Petr Sedlacek, Prof. MD · Department of Paediatric Haematology and Oncology. HSCT Unit Prague

• Marianne Ifversen, MD · Paediatric Clinic II, Rigshospitalet Copenhagen

• Jean-Hugues Dalle, Prof. MD · HSCT Unit Robert Debré Hospital Paris

• Jerry Stein, Prof. MD · Schneider Children's Medical Center, Israel

• Adriana Balduzzi, MD · Ospedale San Gerardo Monza

• Marc Bierings, MD · Wilhelmina Children's Hospital Utrecht

• Jacek Wachowiak, MD, Prof. · Department of Paediatric Oncology, Haematology and Transplantology, University of Medical Sciences Poznan

• Sabina Sufliarska, MD · HSCT Unit, University Children's Hospital Bratislava

• Jacek Toporski, MD · Department of Paediatric Oncology Lund

• Sema Anak, Prof MD · Paediatric HSCT Unit, Istanbul School of Medicine

• Akif Yesilipek, MD Prof · Dep. of Paediatric Haematology-Oncology and HSCT, Akdeniz University School of Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-01-31

Primary Completion

2011-09-30

Completion

2016-09-30

Countries

• Austria
• Czechia
• Denmark
• France
• Israel
• Italy
• Netherlands
• Poland
• Slovakia
• Sweden
• Turkey (Türkiye)

Study Locations