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

Phase 3
Conditions
Lymphoblastic Leukemia, Acute, Childhood;
Interventions
Drug: VP16
Drug: VP16, ATG
Drug: Fludarabine, OKT3, Treosulfan, Thiotepa
Radiation: TBI
Registration Number
NCT01423747
Lead Sponsor
St. Anna Kinderkrebsforschung
Brief Summary

With this protocol the ALL-SZT BFM international study group wants

to evaluate whether hematopoietic 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 haematopoietic stem cell transplantation (HSCT) from mismatched family or unrelated mismatched donors (MMD) as compared to HSCT from matched sibling donor (MSD) and matched donor (MD).

to determine whether therapy has been carried out according to the main haematopoietic stem cell transplantation (HSCT) protocol recommendations. The standardisation of the treatment options during haematopoietic stem cell transplantation (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 haematopoietic stem cell transplantation (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
400
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.
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
MSD - matched sibling donorVP16patients with a MSD receive a conditioning of total body irradiation (TBI) (12 Gy, 6 fractions) and VP16 60mg/kg for one day (-3)
MSD - matched sibling donorTBIpatients with a MSD receive a conditioning of total body irradiation (TBI) (12 Gy, 6 fractions) and VP16 60mg/kg for one day (-3)
MD - matched donorVP16, ATGpatients with a HLA (Human Leukocyte Antigen) matched unrelated Donor (9/10 oder 10/10) receive total body irradiation (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 donorTBIpatients with a HLA (Human Leukocyte Antigen) matched unrelated Donor (9/10 oder 10/10) receive total body irradiation (TBI) (12Gy in 6 fractions), VP16 60mg/kg/d on day -3 and ATG fresenius 20mg/kg/d on day -3,-2,-1
MMD - mismatched DonorFludarabine, OKT3, Treosulfan, ThiotepaPatients 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
MMD - mismatched DonorVP16, ATGPatients 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
MMD - mismatched DonorTBIPatients 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
Primary Outcome Measures
NameTimeMethod
Event-free and overall survival after allogeneic haematopoietic stem cell transplantation (HSCT)14 years
Secondary Outcome Measures
NameTimeMethod
occurrence of acute and chronic Graft-versus-Host-Disease (GvHD)14 years

Evaluation of the incidence and severity of acute Grade I-IV Graft-versus-Host-Disease (GvHD) and of limited or extensive chronic GvHD

occurrence and course of late effects after chemotherapy with subsequent allogeneic hematopoietic stem cell transplantation (HSCT)14 years

Evaluation of incidence of aseptic bone necrosis

occurrence and course of secondary malignancies after chemotherapy with subsequent allogeneic hematopoietic stem cell transplantation (HSCT)14 years

Evaluation of incidence of secondary cancer after total body irradiation (TBI) and/or chemotherapy

Trial Locations

Locations (24)

Universitätskinderklinik

🇩🇪

Ulm, Germany

Universitätsklinikum Düsseldorf, Klinik f. Kinderonkologie, Hämatologie u. Immunologie

🇩🇪

Düsseldorf, Germany

Universitätsklinik für Kinder- und Jugendheilkunde, Klin. Abt. f. Hämato-Onkologie

🇦🇹

Graz, Austria

St. Anna Kinderspital

🇦🇹

Vienna, Austria

Med. Hochschule Hannover, Päd. Hämatologie und Onkologie

🇩🇪

Hannover, Germany

Klinik und Poliklinik für Kinderheilkunde, Hämatologie, Onkologie

🇩🇪

Dresden, Germany

Klinik für Kinder und Jugendliche der Universität Erlangen-Nürnberg

🇩🇪

Erlangen, Germany

Universitätsklinikum Essen, Zentrum für Kinderheilkunde, Abt. für Hämatologie/Onkologie

🇩🇪

Essen, Germany

Universitätsklinik für Kinder- und Jugendheilkunde

🇦🇹

Innsbruck, Austria

Charité Campus Virchow- Klinikum, Klinikum der Pädiatrie, Onkologie/Hämatologie/KMT

🇩🇪

Berlin, Germany

Universitätsklinikum Kiel, Klinik für Allgemeine Pädiatrie

🇩🇪

Kiel, Germany

Klinikum der Universität München, Dr. von Haunersches Kinderspital, Abt. für Hämatologie / Onkologie

🇩🇪

München, Germany

Univ.-Klinik für Kinderheilkunde und Jugendmedizin

🇩🇪

Tübingen, Germany

Universitätsklinik, päd. Onkologie/Stammzelltransplantation

🇩🇪

Würzburg, Germany

Zentrum für Kinderheilkunde, Abt. Hämatologie und Onkologie

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Giessen, Germany

Klinik für Kinderheilkunde III, Hämatologie und Onkologie, Johann Wolfgang Goethe Universität

🇩🇪

Frankfurt am Main, Germany

Universitätsklinikum Freiburg, Zentrum für Kinderheilkunde und Jugendmedizin, Klinik IV: Päd. Hämatologie und Onkologie

🇩🇪

Freiburg, Germany

Klinkum der Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg, Uni. Klinik un Poliklinik für Kinder- und Jugendmedizin

🇩🇪

Halle, Germany

Universitätsklinikum Hamburg-Eppendorf, Kinderklinik, Abt. für Hämatologie und Onkologie

🇩🇪

Hamburg, Germany

Universitätskinderklinik, Päd. Hämatologie, Onkologie und Immunologie

🇩🇪

Heidelberg, Germany

Klinik für Knochenmarktransplantation

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Idar-Oberstein, Germany

Klinik für Kinder- und Jugendmedizin

🇩🇪

Jena, Germany

Städt. Krankenhaus München-Schwabing, Universitätskinderklinik der TU

🇩🇪

München, Germany

Universitätsklinikum Münster, Klinik und Poliklinik für Kinderheilkunde, päd. Hämatologie / Onkologie

🇩🇪

Münster, Germany

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