Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia
This study is ongoing, but not recruiting participants.
Sponsor:
Children's Cancer Research Institute, Austria
Collaborator:
International BFM Study Group
Information provided by (Responsible Party):
Prof. Christina Peters, Children's Cancer Research Institute, Austria
ClinicalTrials.gov Identifier:
NCT01423747
First received: August 25, 2011
Last updated: October 25, 2012
Last verified: October 2012
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Purpose
With this protocol the ALL-SZT BFM international study group wants
to evaluate whether haematopoetic stem cell transplantation (HSCT) from matched family or unrelated matched donors (MD) is equivalent to the HSCT from matched sibling donors (MSD).
to evaluate the efficacy of HSCT from mismatched family or unrelated mismatched donors (MMD) as compared to HSCT from MSD and MD.
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 |
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 and overall survival after allogeneic HSCT [ Time Frame: 14 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- occurrence of acute and chronic GvHD [ Time Frame: 14 years ] [ Designated as safety issue: No ]Evaluation of the incidence and severity of acute Grade I-IV GvHD and of limited or extensive chronic GvHD
- occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT [ Time Frame: 14 years ] [ Designated as safety issue: No ]valuation of organ dysfunctions according to WHO Toxicity score
- occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT [ Time Frame: 14 ] [ 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: 14 years ] [ Designated as safety issue: No ]Evaluation of incidence of aseptic bone necrosis
- occurrence and course of secondary malignancies after chemotherapy with subsequent allogeneic HSCT [ Time Frame: 14 years ] [ Designated as safety issue: No ]Evaluation of incidence of secondary cancer after total body irradiation and/or chemotherapy
| Estimated Enrollment: | 400 |
| Study Start Date: | July 2003 |
| 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 mismatched donor 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 20mg/kd/d on day -3 to day -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 Name: Etoposid, Antithymoglobuline
Radiation: TBI
patients with a MMD-transplantation (8/10) receive 12 Gy in 6 fractions
Other Name: 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 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 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: NCT01423747
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 Kinderspital | |
| Vienna, Austria, 1090 | |
| Germany | |
| Charité Campus Virchow- Klinikum, Klinikum der Pädiatrie, Onkologie/Hämatologie/KMT | |
| Berlin, Germany, 13353 | |
| Klinik und Poliklinik für Kinderheilkunde, Hämatologie, Onkologie | |
| Dresden, Germany, 01307 | |
| Universitätsklinikum Düsseldorf, Klinik f. Kinderonkologie, Hämatologie u. Immunologie | |
| Düsseldorf, Germany, 40001 | |
| Klinik für Kinder und Jugendliche der Universität Erlangen-Nürnberg | |
| Erlangen, Germany, 91054 | |
| Universitätsklinikum Essen, Zentrum für Kinderheilkunde, Abt. für Hämatologie/Onkologie | |
| Essen, Germany, 45122 | |
| Klinik für Kinderheilkunde III, Hämatologie und Onkologie, Johann Wolfgang Goethe Universität | |
| Frankfurt am Main, Germany, 60590 | |
| Universitätsklinikum Freiburg, Zentrum für Kinderheilkunde und Jugendmedizin, Klinik IV: Päd. Hämatologie und Onkologie | |
| Freiburg, Germany, 79106 | |
| Zentrum für Kinderheilkunde, Abt. Hämatologie und Onkologie | |
| Giessen, Germany, 35385 | |
| Klinkum der Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg, Uni. Klinik un Poliklinik für Kinder- und Jugendmedizin | |
| Halle, Germany, 06097 | |
| Universitätsklinikum Hamburg-Eppendorf, Kinderklinik, Abt. für Hämatologie und Onkologie | |
| Hamburg, Germany, 20246 | |
| Med. Hochschule Hannover, Päd. Hämatologie und Onkologie | |
| Hannover, Germany, 30625 | |
| Universitätskinderklinik, Päd. Hämatologie, Onkologie und Immunologie | |
| Heidelberg, Germany, 69120 | |
| Klinik für Knochenmarktransplantation | |
| Idar-Oberstein, Germany, 55743 | |
| Klinik für Kinder- und Jugendmedizin | |
| Jena, Germany, 07724 | |
| Universitätsklinikum Kiel, Klinik für Allgemeine Pädiatrie | |
| Kiel, Germany, 24105 | |
| Klinikum der Universität München, Dr. von Haunersches Kinderspital, Abt. für Hämatologie / Onkologie | |
| München, Germany, 80337 | |
| Städt. Krankenhaus München-Schwabing, Universitätskinderklinik der TU | |
| München, Germany, 80804 | |
| Universitätsklinikum Münster, Klinik und Poliklinik für Kinderheilkunde, päd. Hämatologie / Onkologie | |
| Münster, Germany, 48149 | |
| Univ.-Klinik für Kinderheilkunde und Jugendmedizin | |
| Tübingen, Germany, 72076 | |
| Universitätskinderklinik | |
| Ulm, Germany, 89075 | |
| Universitätsklinik, päd. Onkologie/Stammzelltransplantation | |
| Würzburg, Germany, 97080 | |
Sponsors and Collaborators
Children's Cancer Research Institute, Austria
International BFM Study Group
Investigators
| Study Chair: | Arend v. Stackelberg, MD, PhD | ALL-REZ BFM Study Center Berlin Germany |
| Study Chair: | Martin Schrappe, MD, Prof. | ALL BFM study center Kiel, Germany |
More Information
Additional Information:
Publications:
| Responsible Party: | Prof. Christina Peters, MD, PHD, Children's Cancer Research Institute, Austria |
| ClinicalTrials.gov Identifier: | NCT01423747 History of Changes |
| Other Study ID Numbers: | ALL-SZT- BFM 2003 |
| Study First Received: | August 25, 2011 |
| Last Updated: | October 25, 2012 |
| Health Authority: | Austria: Federal Ministry for Health Family and Youth |
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 16, 2013