ALL-SCT BFM International- HSCT in Children and Adolescents With ALL (ALL-SCT-BFMi)
This study is ongoing, but not recruiting participants.
Sponsor:
Children's Cancer Research Institute, Austria
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: September 30, 2011
Last verified: September 2011
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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 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 MSD, from MD and from MMD.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoblastic Leukemia, Acute, Childhood; |
Drug: VP16 Radiation: TBI Drug: VP16, ATG Drug: Fludarabine, OKT3, Treosulfan, Thiotepa Drug: VP16, ATG |
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:
Drug Information available for:
Thiotepa
Fludarabine
Etoposide
Fludarabine phosphate
Etoposide phosphate
Antilymphocyte Serum
U.S. FDA Resources
Further study details as provided by Children's Cancer Research Institute, Austria:
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:
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 HSCT
- complete remission 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:
- 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
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 | |
| Department of Pediatrics, Gülhane Military Medical Academy | |
| Ankara, Turkey, 06018 | |
| Dept. of Paediatrics - BMT Unit, School of Medicine, University of Ankara | |
| Ankara, Turkey, 06100 | |
| 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
Children's Cancer Research Institute, Austria
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: | September 30, 2011 |
| 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 Children's Cancer Research Institute, Austria:
|
ALL HSCT children adolescents |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Antilymphocyte Serum Thiotepa Fludarabine monophosphate Etoposide Etoposide phosphate Fludarabine |
Treosulfan Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 23, 2013