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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Prof. Christina Peters, Children's Cancer Research Institute, Austria
ClinicalTrials.gov Identifier:
NCT01423500
First received: August 23, 2011
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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).

Condition Intervention Phase
Lymphoblastic Leukemia, Acute, Childhood;
Drug: VP16
Radiation: TBI
Drug: VP16, ATG
Drug: Fludarabine, OKT3, Treosulfan, Thiotepa
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia

Resource links provided by NLM:


Further study details as provided by St. Anna Kinderkrebsforschung:

Primary Outcome Measures:
  • Event free survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    Event-free and overall survival after allogeneic HSCT


Secondary Outcome Measures:
  • number of patients with GvHD acute and chronic Graft-versus-Host-Disease (GvHD) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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

  • occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    evaluation of organ dysfunctions according to WHO Toxicity score

  • occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    evaluation of growth retardation and endocrine dysfunction

  • occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Evaluation of incidence of aseptic bone necrosis.

  • occurrence and course of subsequent malignancies after chemotherapy with subsequent allogeneic HSCT [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Evaluation of incidence of secondary cancer after total body irradiation and/or chemotherapy


Estimated Enrollment: 405
Study Start Date: January 2007
Estimated Study Completion Date: September 2016
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Etoposid
Radiation: TBI
patients with a MSD receive TBI (12Gy in 6 fractions) as conditioning
Other Name: Total body irradiation
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
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 Name: Etoposid, Antithymoglobuline
Radiation: TBI
patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive TBI (12Gy in 6 fractions)
Other Name: total body irradiation
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
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 Name: ATG: 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:
  • VP16: Etoposid
  • ATG: Antithymoglobuline
Radiation: TBI
patients with a MMD-transplantation (8/10) receive 12 Gy in 6 fractions
Other Name: TBI: total body irradiation

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.

  Eligibility

Ages Eligible for Study:   3 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423500

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

Additional Information:
Publications:
Responsible Party: Prof. Christina Peters, MD, PhD, Children's Cancer Research Institute, Austria
ClinicalTrials.gov Identifier: NCT01423500     History of Changes
Other Study ID Numbers: EudraCT 2005-005106-23
Study First Received: August 23, 2011
Last Updated: August 19, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: The Israel National Institute for Health Policy Research and Health Services Research
Netherlands: Medical Ethics Review Committee (METC)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Sweden: Medical Products Agency
Turkey: Ministry of Health

Keywords provided by St. Anna Kinderkrebsforschung:
ALL
HSCT
children
adolescents

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Etoposide
Etoposide phosphate
Fludarabine
Fludarabine phosphate
Treosulfan
Alkylating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014