ALL-SCT BFM International- HSCT in Children and Adolescents With ALL
- Conditions
- Lymphoblastic Leukemia, Acute, Childhood;
- Interventions
- Registration Number
- NCT01423500
- Lead Sponsor
- St. Anna Kinderkrebsforschung
- Brief 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).
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 405
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MMD - Mismatched Donor Fludarabine, OKT3, Treosulfan, Thiotepa 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 MMD - Mismatched Donor TBI 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 MSD - Matched Sibling Donor TBI patients with a MSD receive a conditioning of TBI (12 Gy, 6 fractions) and VP16 60mg/kg for one day (-3) MMD - Mismatched Donor VP16, ATG 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 MSD - Matched Sibling Donor VP16 patients with a MSD receive a conditioning of TBI (12 Gy, 6 fractions) and VP16 60mg/kg for one day (-3) MD - Matched Donor VP16, ATG 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 MD - Matched Donor TBI 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
- Primary Outcome Measures
Name Time Method Event free survival 10 years Event-free and overall survival after allogeneic HSCT
- Secondary Outcome Measures
Name Time Method number of patients with GvHD acute and chronic Graft-versus-Host-Disease (GvHD) 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
occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT 10 years Evaluation of incidence of aseptic bone necrosis.
occurrence and course of subsequent malignancies after chemotherapy with subsequent allogeneic HSCT 10 years Evaluation of incidence of secondary cancer after total body irradiation and/or chemotherapy
Trial Locations
- Locations (24)
Pediatric Immuno-Hematology Unit Robert Debré Hospital
🇫🇷Paris, France
Leiden University Hospital
🇳🇱Leiden, Netherlands
Department of Pediatric Oncology, Lund University Hospital
🇸🇪Lund, Sweden
Pediatric Clinic II, Rigshospitalet
🇩🇰Copenhagen, Denmark
Clinica Pediatrica dell'Universita di Milano Bicocca, Hospitale San Gerardo
🇮🇹Monza, Italy
Department of Pediatrics, Gülhane Military Medical Academy
🇹🇷Ankara, Turkey
Pediatric BMT Centre, Ege University
🇹🇷Izmir, Turkey
Universitätsklinik für Kinder- und Jugendheilkunde, Klin. Abt. f. Hämato-Onkologie
🇦🇹Graz, Austria
Children's University Hospital - Hematology - Oncology
🇵🇱Lublin, Poland
Department of Paediatric Haematology and Oncology HSCT-Unit
🇨🇿Prague, Czech Republic
Radboud University - Nijmegen Medical Centre
🇳🇱Nijmegen, Netherlands
Schneider Children's Medical Center of Israel
🇮🇱Petach-Tikva, Israel
Department of Transplantation, University Children's Hospital
🇵🇱Cracow, Poland
Department of Pediatric Bone Marrow Transplantation Unit, University Childrens´ Hospital
🇸🇰Bratislava, Slovakia
St. Anna Children's Hospital
🇦🇹Vienna, Austria
Department of Paediatric Haematology and Oncology, Wilhelmina Children's Hospital
🇳🇱Utrecht, Netherlands
Dept. of Paediatrics - BMT Unit, School of Medicine, University of Ankara
🇹🇷Ankara, Turkey
Department of Pediatric Hematology-Oncology and Pediatric Stem Cell Transplantation, Akdeniz University School of Medicine
🇹🇷Antalya, Turkey
Universitätsklinik für Kinder- und Jugendheilkunde
🇦🇹Innsbruck, Austria
Rambam Medical Center
🇮🇱Haifa, Israel
University Hospital, Collegium Medicum UMK, Pediatric Hematology and Oncology
🇵🇱Bydgoszcz, Poland
Department of Pediadric Oncology, Hematology and Transplantology, University of Medical Sciences
🇵🇱Poznan, Poland
Wroclaw Medical University, Dept. of Children Hematology and Oncology
🇵🇱Wroclaw, Poland
Department of Pediatric Hematology, Oncology and BMT, Istanbul School of Medicine
🇹🇷Istanbul, Turkey