ALL-SCT BFM International- HSCT in Children and Adolescents With ALL (ALL-SCT-BFMi)

June 25, 2015 updated by: Prof. Christina Peters, St. Anna Kinderkrebsforschung

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with high risk or relapsed acute lymphoblastic leukaemia (ALL) have a worse prognosis compared to all other patients with ALL. For these patients additional therapy approaches are required after they have achieved remission with multimodal chemotherapy. Allogeneic haematopoetic stem cell transplantation shows promising results mainly due to an immunological antileukaemic control by the graft-versus-leukaemia effect but treatment related mortality and morbidity remains a serious problem.

Study Type

Interventional

Enrollment (Anticipated)

405

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Universitätsklinik für Kinder- und Jugendheilkunde, Klin. Abt. f. Hämato-Onkologie
      • Innsbruck, Austria, 6020
        • Universitätsklinik für Kinder- und Jugendheilkunde
      • Vienna, Austria, A-1090
        • St. Anna Children's Hospital
  • Czech Republic
      • Prague, Czech Republic, 15006
        • Department of Paediatric Haematology and Oncology HSCT-Unit
  • Denmark
      • Copenhagen, Denmark, 4074
        • Pediatric Clinic II, Rigshospitalet
  • France
      • Paris, France, 75935
        • Pediatric Immuno-Hematology Unit Robert Debré Hospital
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Petach-Tikva, Israel, 49202
        • Schneider Children's Medical Center of Israel
  • Italy
      • Monza, Italy, 20052
        • Clinica Pediatrica dell'Universita di Milano Bicocca, Hospitale San Gerardo
  • Netherlands
      • Leiden, Netherlands, 2300
        • Leiden University Hospital
      • Nijmegen, Netherlands, 6500
        • Radboud University - Nijmegen Medical Centre
      • Utrecht, Netherlands, 3584
        • Department of Paediatric Haematology and Oncology, Wilhelmina Children's Hospital
  • Poland
      • Bydgoszcz, Poland, 85-094
        • University Hospital, Collegium Medicum UMK, Pediatric Hematology and Oncology
      • Cracow, Poland, 30-663
        • Department of Transplantation, University Children's Hospital
      • Lublin, Poland, 20-093
        • Children's University Hospital - Hematology - Oncology
      • Poznan, Poland, 60-572
        • Department of Pediadric Oncology, Hematology and Transplantology, University of Medical Sciences
      • Wroclaw, Poland, 50-345
        • Wroclaw Medical University, Dept. of Children Hematology and Oncology
  • Slovakia
      • Bratislava, Slovakia, 833 40
        • Department of Pediatric Bone Marrow Transplantation Unit, University Childrens´ Hospital
  • Sweden
      • Lund, Sweden, 221-85
        • Department of Pediatric Oncology, Lund University Hospital
  • Turkey
      • Ankara, Turkey, 06018
        • Department of Pediatrics, Gülhane Military Medical Academy
      • Ankara, Turkey, 06100
        • Dept. of Paediatrics - BMT Unit, School of Medicine, University of Ankara
      • Antalya, Turkey, 07070
        • Department of Pediatric Hematology-Oncology and Pediatric Stem Cell Transplantation, Akdeniz University School of Medicine
      • Istanbul, Turkey, 343990
        • Department of Pediatric Hematology, Oncology and BMT, Istanbul School of Medicine
      • Izmir, Turkey, 35100
        • Pediatric BMT Centre, Ege University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age at time of initial diagnosis or relapse diagnosis, respectively under or equal 18 years
  • indication for allogeneic hematopoietic stem cell transplantation(HSCT)
  • complete remission before hematopoietic stem cell transplantation (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 hematopoietic stem cell transplantation (HSCT)
  • hematopoietic stem cell transplantation (HSCT) is performed in a study participating centre.

Exclusion Criteria:

  • age at time of initial diagnosis or relapse diagnosis, respectively above 18 years
  • no indication for allogeneic HSCT
  • no complete remission before SCT
  • no written consent of the parents (legal guardian) and, if necessary, the minor patient via Informed Consent Form
  • pregnancy
  • secondary malignancy
  • previous HSCT
  • HSCT is not performed in a study participating centre.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MSD - Matched Sibling Donor
patients with a MSD receive a conditioning of TBI (12 Gy, 6 fractions) and VP16 60mg/kg for one day (-3)
Drug: VP16
patients with MSD receive as conditioning VP16 60mg/kg/d on day -3
Other Names:
  • Etoposid
Radiation: TBI
patients with a MSD receive TBI (12Gy in 6 fractions) as conditioning
Other Names:
  • Total body irradiation
Radiation: TBI
patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive TBI (12Gy in 6 fractions)
Other Names:
  • total body irradiation
Radiation: TBI
patients with a MMD-transplantation (8/10) receive 12 Gy in 6 fractions
Other Names:
  • TBI: total body irradiation
Other: MD - Matched Donor
patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive TBI (12Gy in 6 fractions), VP16 60mg/kg/d on day -3 and ATG fresenius 20mg/kg/d on day -3,-2,-1
Radiation: TBI
patients with a MSD receive TBI (12Gy in 6 fractions) as conditioning
Other Names:
  • Total body irradiation
Radiation: TBI
patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive TBI (12Gy in 6 fractions)
Other Names:
  • total body irradiation
Radiation: TBI
patients with a MMD-transplantation (8/10) receive 12 Gy in 6 fractions
Other Names:
  • TBI: total body irradiation
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
Other Names:
  • Etoposid, Antithymoglobuline
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
Other Names:
  • ATG: Antithymoglobuline
  • VP16: Etoposid
Other: MMD - Mismatched Donor
Patients with a MMD receive stem cells either from cord blood, a haploidentical donor (parent) or from a non-related donor with a match less or equal 8/10
Radiation: TBI
patients with a MSD receive TBI (12Gy in 6 fractions) as conditioning
Other Names:
  • Total body irradiation
Radiation: TBI
patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive TBI (12Gy in 6 fractions)
Other Names:
  • total body irradiation
Radiation: TBI
patients with a MMD-transplantation (8/10) receive 12 Gy in 6 fractions
Other Names:
  • TBI: total body irradiation
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
Other Names:
  • Etoposid, Antithymoglobuline
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
Other Names:
  • ATG: Antithymoglobuline
  • VP16: Etoposid
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
Other Names:
  • ATG: Antithymoglobuline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event free survival
Time Frame: 10 years
Event-free and overall survival after allogeneic HSCT
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients with GvHD acute and chronic Graft-versus-Host-Disease (GvHD)
Time Frame: 10 years
evaluation of the incidence and severity of acute Grade I-IV graft versus Host disease and of limited or extensive chronic graft versus host disease
10 years
occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT
Time Frame: 10 years
evaluation of organ dysfunctions according to WHO Toxicity score
10 years
occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT
Time Frame: 10 years
evaluation of growth retardation and endocrine dysfunction
10 years
occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT
Time Frame: 10 years
Evaluation of incidence of aseptic bone necrosis.
10 years
occurrence and course of subsequent malignancies after chemotherapy with subsequent allogeneic HSCT
Time Frame: 10 years
Evaluation of incidence of secondary cancer after total body irradiation and/or chemotherapy
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Anna Kinderkrebsforschung

Investigators

  • Study Chair: Christina Peters Peters, Prof MD PHD, St. Anna Kinderkrebsforschung
  • Principal Investigator: Petr Sedlacek, Prof. MD, Department of Paediatric Haematology and Oncology. HSCT Unit Prague
  • Principal Investigator: Marianne Ifversen, MD, Paediatric Clinic II, Rigshospitalet Copenhagen
  • Principal Investigator: Jean-Hugues Dalle, Prof. MD, HSCT Unit Robert Debré Hospital Paris
  • Principal Investigator: Jerry Stein, Prof. MD, Schneider Children's Medical Center, Israel
  • Principal Investigator: Adriana Balduzzi, MD, Ospedale San Gerardo Monza
  • Principal Investigator: Marc Bierings, MD, Wilhelmina Children's Hospital Utrecht
  • Principal Investigator: Jacek Wachowiak, MD, Prof., Department of Paediatric Oncology, Haematology and Transplantology, University of Medical Sciences Poznan
  • Principal Investigator: Sabina Sufliarska, MD, HSCT Unit, University Children's Hospital Bratislava
  • Principal Investigator: Jacek Toporski, MD, Department of Paediatric Oncology Lund
  • Principal Investigator: Sema Anak, Prof MD, Paediatric HSCT Unit, Istanbul School of Medicine
  • Principal Investigator: Akif Yesilipek, MD Prof, Dep. of Paediatric Haematology-Oncology and HSCT, Akdeniz University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

September 1, 2011

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

August 23, 2011

First Submitted That Met QC Criteria

August 25, 2011

First Posted (Estimate)

August 26, 2011

Study Record Updates

Last Update Posted (Estimate)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT 2005-005106-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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