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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT01949129

Studienbeginn:
April 2013

Letztes Update:
16.01.2024

Wirkstoff:
VP16, Thiotepa, Treosulfan, Fludarabine, Busulfan, ATG Thymoglobulin, Cyclophosphamide, Grafalon

Indikation (Clinical Trials):
Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphoid

Geschlecht:
Alle

Altersgruppe:
Kinder (0-17)

Phase:
-

Sponsor:
St. Anna Kinderkrebsforschung

Collaborator:
ALL SCTped Forum, European Society for Blood and Marrow Transplantation, ALL-BFM Study Group, Assistance Publique - Hôpitaux de Paris, Dutch Childhood Oncology Group, Swiss Pediatric Oncology Group, Australian & New Zealand Children's Haematology/Oncology Group

Studienleiter

Christina Peters, Prof. MD PhD
Study Chair
St. Anna Kinderspital, Vienna, Austria
Peter Bader, Prof. MD PhD
Study Chair
Goethe University
Franco Locatelli, Prof. MD PhD
Study Chair
Ospedale Pediatrico Bambino Gesù, Rome, Italy

Kontakt

Christina Peters, Prof. MD PhD
Kontakt:
Phone: +43140170
Phone (ext.): 3106
E-Mail: christina.peters@stanna.at» Kontaktdaten anzeigen

Studienlocations
(3 von 119)

Uniklinik RWTH Aachen, Kinder- und Jugendmedizin
52074 Aachen
GermanyAktiv, nicht rekrutierend» Google-Maps
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum
13353 Berlin
(Berlin)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Bonn, Abteilung für Pädiatrische Hämatologie und Onkologie
53113 Bonn
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Düsseldorf, Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immunologie
40225 Düsseldorf
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Erlangen, Kinder- und Jugendklinik
1054 Erlangen
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Essen, Klinik für Kinderheilkunde III
45122 Essen
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Klinikum der Johann Wolfgang Goethe-Universität, Klinik für Kinder- und Jugendmedizin (KKJM)
60590 Frankfurt am Main
(Hessen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin
79106 Freiburg
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Gießen, Zentrum für Kinder- und Jugendmedizin
35392 Gießen
(Hessen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsmedizin Greifswald, Klinik und Poliklinik für Kinder- und Jugendmedizin
17475 Greifswald
(Mecklenburg-Vorpommern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Kinder- und Jugendmedizin
06120 Halle
(Sachsen-Anhalt)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Pädiatrische Hämatologie und Onkologie
20246 Hamburg
(Hamburg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Medizinische Hochschule Hannover, Zentrum Kinderheilkunde und Jugendmedizin
30625 Hannover
(Niedersachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Heidelberg, Zentrum für Kinder- und Jugendmedizin
69120 Heidelberg
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Jena, Sektion für Stammzelltransplantation
07745 Jena
(Thüringen)
GermanyAktiv, nicht rekrutierend» Google-Maps
UKSH - Universitätsklinikum Schleswig-Holstein, Klinik für Allgemeine Pädiatrie
24105 Kiel
(Schleswig-Holstein)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsmedizin Leipzig, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie
04103 Leipzig
(Sachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Klinikum der Universität München, Dr. von Haunersches Kinderspital
80337 München
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Städt. Krankenhaus München Schwabing, Universitätskinderklinik der TU München
80804 München
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin
48149 Münster
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Regensburg, Klinik und Poliklinik für Kinder- und Jugendmedizin
93053 Regensburg
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinik für Kinder- und Jugendmedizin Tübingen
72076 Tübingen
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin
89075 Ulm
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitäts-Kinderklinik Würzburg
97080 Würzburg
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Hospital Sor Maria Ludovica, Department Hematology Stem Cell Transplant Unit
1651 La Plata
ArgentinaRekrutierend» Google-Maps
Ansprechpartner:
Alcira Fynn, MD PhD
E-Mail: alcirafynn@hotmail.com

Formisano Sandra, MD PhD
E-Mail: sandraformisano@yahoo.com.ar» Ansprechpartner anzeigen
Children's Cancer Centre The Royal Children's Hospital
3052 Melbourne
AustraliaAktiv, nicht rekrutierend» Google-Maps
Princess Margaret Hospital for Children
6008 Perth
AustraliaAktiv, nicht rekrutierend» Google-Maps
Sydney Children's Hospital
2031 Randwick
AustraliaAktiv, nicht rekrutierend» Google-Maps
Lady Cilento Children's Hospital
4101 South Brisbane
AustraliaAktiv, nicht rekrutierend» Google-Maps
The Children's Hospital at Westmead Oncology Unit
2145 Sydney
AustraliaAktiv, nicht rekrutierend» Google-Maps
Universitätsklinik für Kinder- und Jugendheilkunde, Abt. f. Hämato-Onkologie
8036 Graz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Wolfgang Schwinger, MD PhD
E-Mail: wolfgang.schwinger@medunigraz.at» Ansprechpartner anzeigen
Universitätsklinik für Kinder- und Jugendheilkunde
6020 Innsbruck
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Gabriele Kropshofer, MD PhD
E-Mail: gabriele.kropshofer@tirol-kliniken.at» Ansprechpartner anzeigen
Cliniques Universitaires Saint-Luc (UCL) Hématologie et oncologie pédiatrique
1200 Brussels
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Benedicte Brichard, MD PhD
E-Mail: benedicte.brichard@uclouvain.be» Ansprechpartner anzeigen
Centre Hospitalier Universitaire de Liège Domaine Universitaire du Sart Tilman
Liège
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Marie Françoise Dresse, MD PhD
E-Mail: marie.francoise.dresse@chrcitadelle.be» Ansprechpartner anzeigen
Alberta Children's Hospital Division of Pediatric Oncology
Calgary
CanadaAktiv, nicht rekrutierend» Google-Maps
Montreal Children's Hospital
Montral
CanadaAktiv, nicht rekrutierend» Google-Maps
Department of Pediatric Hematology and Oncology Teaching Hospital Motol, 2nd Medical School, Charles University
150 06 Prague
CzechiaRekrutierend» Google-Maps
Ansprechpartner:
Petr Sedlacek, MD PhD
E-Mail: petr.sedlacek@fnmotol.cz» Ansprechpartner anzeigen
Paediatric Stem Cell Transplant and Immune Deficiency, Dept. for children and adolescents 4072, Rigshospitalet
2100 Copenhagen
DenmarkRekrutierend» Google-Maps
Ansprechpartner:
Marianne Ifversen, MD PhD
E-Mail: ifversen@rh.regionh.dk» Ansprechpartner anzeigen
Division of Hematology-Oncology and Stem Cell Transplantation, Hospital for Children and Adolescents, Univ. of Helsinki
00029 HUS Helsinki
FinlandRekrutierend» Google-Maps
Ansprechpartner:
Kim Vettenranta, MD PhD
E-Mail: kim.vettenranta@hus.fi» Ansprechpartner anzeigen
CHU Clermont-Ferrand
63003 Clermont-Ferrand
FranceAktiv, nicht rekrutierend» Google-Maps
CHU Grenoble - Clinique Universitaire de Pédiatrie, Hôpital Couple Enfant
38043 Grenoble
FranceAktiv, nicht rekrutierend» Google-Maps
CHRU Lille, Service d'Hématologie Pédiatrique
59037 Lille
FranceAktiv, nicht rekrutierend» Google-Maps
IHOP / Lyon, Service Hématologie et d'Oncologie pédiatrique
69372 Lyon
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital la Timone Adulte
13385 Marseille
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital Arnaud de Villeneuve
34295 Montpellier
FranceAktiv, nicht rekrutierend» Google-Maps
CHU Nancy - Hopital d'Enfants
54500 Nancy
FranceAktiv, nicht rekrutierend» Google-Maps
CHU Nantes, Service d'onco hémato pédiatrie
44093 Nantes
FranceAktiv, nicht rekrutierend» Google-Maps
Hôpital Robert Debré
75019 Paris
FranceAktiv, nicht rekrutierend» Google-Maps
CHU de Rennes, Serive d'Onco-Pédiatrie
35203 Rennes
FranceAktiv, nicht rekrutierend» Google-Maps
CHU de Rouen, Hopital des Enfants, Service d' Immuno-Hématologie Oncologie Pédiatrique
76031 Rouen
FranceAktiv, nicht rekrutierend» Google-Maps
CHU Strasbourg, Service d'hématologie et d'oncologie pédiatrique
67098 Strasbourg
FranceAktiv, nicht rekrutierend» Google-Maps
Saint Sophia Children's Hospital BMT Unit
11527 Athens
GreeceRekrutierend» Google-Maps
Ansprechpartner:
Evgenios Goussetis, MD
E-Mail: evgoussetis@gmail.com

Dikaia Eleni Ioannidou, MD
E-Mail: elda.ioannidou@gmail.com» Ansprechpartner anzeigen
National Institute of Haematology and Infectious Disease, Hospital of Southern Pest, Paediatric Bone Marrow Transplantation Unit
1097 Budapest
HungaryRekrutierend» Google-Maps
Ansprechpartner:
Gergely Krivan, MD PhD
E-Mail: krivang@hu.inter.net» Ansprechpartner anzeigen
Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi di Bologna
40138 Bologna
ItalyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Fraia Melchionda, MD
E-Mail: fraia.melchionda@aosp.bo.it» Ansprechpartner anzeigen
Ospedale Mayer di Firenze SODc Tumori Pediatrici e TMO
50139 Florence
ItalyZurückgezogen» Google-Maps
A.O.R.N. Santobono Pausilipon, Dipartimento di Oncoematologia
80123 Napoli
ItalyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Francesco Paolo Tambaro, MD
E-Mail: fp.tambaro@gmail.com» Ansprechpartner anzeigen
Azienda Ospedaliero Universitaria Pisana U.O. di Oncoematologia Pediatrica A.O.
56126 Pisa
ItalyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Gabriella Casazza, MD PhD
E-Mail: g.casazza@libero.it» Ansprechpartner anzeigen
Ospedale Infantile Regina Margherita SC Oncoematologia e Centro Trapianti
10126 Torino
ItalyAbgebrochen» Google-Maps
Starship Children's Hospital
1142 Auckland
New ZealandAktiv, nicht rekrutierend» Google-Maps
University Hospital No.1, Collegium Medicum UMK, department of Paediatrics, Oncology, Hematology and Paediatric Transplantology
Bydgoszcz
PolandRekrutierend» Google-Maps
Ansprechpartner:
Mariusz Wysocki, MD PhD
E-Mail: tsk@cm.umk.pl» Ansprechpartner anzeigen
University Children's Hospital in Krakow, Department of Transplantation
Kraków
PolandZurückgezogen» Google-Maps
Children's University Hospital, Dept. Pediatric Hematology, Oncology, and Transplantology
Lublin
PolandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Jerzy R. Kowalczyk, MD
E-Mail: jerzy.kowalczyk@dsk.lublin.pl» Ansprechpartner anzeigen
Poznan University of Medical Sciences, Department of Pediatric Onology, Hematology & HSCT
Poznań
PolandRekrutierend» Google-Maps
Ansprechpartner:
Jacek Wachowiak, MD PhD
E-Mail: jacek.wachowiak@plusnet.pl» Ansprechpartner anzeigen
University of Medicine and Pharmacy V. BABES, Emergency Children's Hospital LOUIS TURCANU, III. Clinic of Pediatrics , Department of Onco-hematology and Bone Marrow Transplantation
Timişoara
RomaniaRekrutierend» Google-Maps
Ansprechpartner:
Cristian Jinca, MD PhD
E-Mail: cristian_jinca@yahoo.com» Ansprechpartner anzeigen
Queen Silvia Children's Hospital, Department of Pediatric Oncology (Avdelnig 321-322)
41685 Göteborg
SwedenRekrutierend» Google-Maps
Ansprechpartner:
Cecilia Langenskiöld, MD
E-Mail: cecilia.langenskiold@vgregion.se» Ansprechpartner anzeigen
Skane University Hospital, Dept. of Pediatrics, Section for Hematology and Oncology
22185 Lund
SwedenRekrutierend» Google-Maps
Ansprechpartner:
Dominik Turkiewicz, MD
E-Mail: dominik.turkiewicz@skane.se» Ansprechpartner anzeigen
University Children's Hospital, Dept. of Women's & Children's Health Section for Pediatrics
75185 Uppsala
SwedenRekrutierend» Google-Maps
Ansprechpartner:
Natalja Jackman, MD PhD
E-Mail: natalja.jackman@akademiska.se» Ansprechpartner anzeigen
Ankara University School of Medicine Pediatric Stem Cell Transplantation Unit
06100 Ankara
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Mehmet Ertem, MD PhD

Elif Ince, MD
E-Mail: elifunal@msn.com» Ansprechpartner anzeigen
Akdeniz University School of Medicine Pediatric Stem Cell Transplantation Unit
Antalya
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Alphan Kupesiz, MD PhD
E-Mail: akupesiz@akdeniz.edu.tr» Ansprechpartner anzeigen
Bahcelievler Medicalpark Hospital Pediatric Stem Cell Transplantation Unit
Istanbul
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Tunc Fisgin, MD PhD
E-Mail: Tunc.fisgin@medicalparc.com.tr» Ansprechpartner anzeigen
Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit
Istanbul
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Gulsun Karasu, MD PhD
E-Mail: gulsuntezcan@gmail.com» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

Acute and late side effects of TBI in combination with other chemotherapeutic are manifold to

the growing organism and include severe organ dysfunction/failure due to toxicity. Although

transplant associated mortality was reduced after HSCT in the last decade due to better HLA

matching, infection prevention and control, the burden of late complications is still a

matter of concern. Growth retardation, hormonal dysfunction, sterility and the risk of

secondary cancer are the late consequences of TBI in children. However, so far no prospective

study has demonstrated similar outcomes in paediatric ALL using chemo-conditioning regimen

before HSCT. The reason for that is manifold: only a minority of children with ALL qualifies

for allogeneic HSCT as most patients are cured with sole modern chemotherapy approaches.

Those with dismal prognosis are treated in HSCT centres offering a care to patients with

different diseases. Therefore it is nearly impossible to answer the complex outcome questions

in single centres or even in single countries. International cooperation is essential to

allow prospective investigation within comparable patient cohorts.

The trial was initiated to investigate whether chemotherapy based conditioning could replace

TBI in pediatric patients with acute lymphoblastic leukemia (ALL) undergoing allogeneic

hematopoietic stem cell transplantation (HSCT). It was registered and approved as a

prospective, randomized, controlled, open-label, international, multicenter, phase III,

non-inferiority trial. Pediatric patients with acute lymphoblastic leukemia (ALL) aged ≤18

years at diagnosis and 4-21 years at HSCT in complete remission pre-HSCT, and with an

HLA-compatible related (MSD) or unrelated donor (MD) were randomly assigned to myeloablative

conditioning with fractionated 12 Gy TBI and etoposide versus fludarabine (Flu), thiotepa

(Thio), and either busulfan (Bu) or treosulfan (Treo). The decision to use the

irradiation-free conditioning or Flu/Thio/Treo or Flu/Thio/ivBu was country specific.

Patients aged < 4 years received irradiation-free conditioning. Patients with a mismatched

donor (MMD) were stratified according to the donor's stem cell source (cordblood,

haploidentical tx or bone marrow/peripheral blood stem cells).

The stopping rule was applied on March 31, 2019 following a suspension of random assignment

in December 2018 after the chemoconditioning was proven to be significantly inferior to TBI.

As a result, TBI/VP16 conditioning remains the standard for patients older than 4 years with

MSD/MD, but the age limit for TBI/VP16-based conditioning may be optionally lowered to 2

years.The use of Flu/Thio/Treo or Flu/Thio/ivBu conditioning in this age group is made at

centre level based on individual patient assessment. Alternatively, patients aged 0-2 years

may receive Bu/VP16/Cy at the discretion of the treating physician.

The MSD/MD randomised patients remain in a follow-up to explore the impact of risk factors on

the incidence of Adverse Events of Special Interest (AESIs) and on overall survival and event

free survival in the entire MSD/MD cohort.

In MMD patients, event free survival (EFS) after HSCT from HLA mismatched donors using

mismatched unrelated donors (MMD), mismatched cord blood or HLA haplo-identical family

members is observed

Ein-/Ausschlusskriterien

Inclusion Criteria:

Patients with ALL (except for patients with B-ALL) who fulfil the following criteria:

- age at diagnosis ≤ 18 years. Age at HSCT ≤ 21 years

- indication for allogeneic HSCT

- complete remission (CR) 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:

- patients who do not fulfil the inclusion criteria

- Non Hodgkin-Lymphoma

- the whole protocol or essential parts are declined either by patient himself/herself

or the respective legal guardian

- no consent is given for saving and propagation of anonymous medical data for study

reasons

- severe concomitant disease that does not allow treatment according to the protocol at

the investigator's discretion (e.g. malformation syndromes, cardiac malformations,

metabolic disorders)

- Karnofsky / Lansky score < 50%

- subjects unwilling or unable to comply with the study procedures

Studien-Rationale

Primary outcome:

1. Overall Survival (OS) Stratum 1a (randomisation TBI+ chemo-conditioning vs. chemo-conditioning only) (Time Frame - first: 18 months after inclusion of first patient, afterwards annually up to 10 years):
Stratum 1 - randomisation related question was closed in December 2018; patients are in active follow-up: To show that a non total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu or Flu/Thio/Treo) results in a non-inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human leucocyte antigen (HLA) identical sibling donor (MSD) or a HLA matched donor (MD). The primary endpoint is the OS calculated from the date of the randomisation. Death from any cause will be considered an event.

2. Event free survival (EFS) Stratum 2 (mismatched donor transplantation) (Time Frame - first: 18 months after inclusion of first patient, afterwards annually up to 10 years):
EFS after allogeneic HSCT. EFS calculated from date of recruitment to disease progression or relapse, secondary neoplasm and death from any cause.

3. Overall Survival (OS), Stratum 1b: MSD/MD without randomisation (Time Frame - first: 18 months after inclusion of first patient, afterwards annually up to 10 years):
To explore the impact of risk factors on the incidence of adverse events of special interest (AESIs) and on overall survival and event free survival in the entire MSD/MD cohort

Secondary outcome:

1. EFS (Stratum 1a and 1b) (Time Frame - first: 18 months after inclusion of first patient, afterwards annually up to 10 years):
EFS calculated from date of randomization (1a) or recruitment (1b) to disease progression or relapse, secondary neoplasm and death from any cause. Patients lost to follow-up without event will be censored at the date of their last follow-up evaluation.

2. TRM (Time Frame - first: 18 months after inclusion of first patient, afterwards annually up to 10 years):
Cumulative Incidence of Treatment-related mortality (TRM) for Stratum 1 and 2.

3. Relapse/progression (Time Frame - first: 18 months after inclusion of first patient, afterwards annually up to 10 years):
Cumulative Incidence of Relapse for Stratum 1a, 1b and 2.

4. Acute and late toxicity for Stratum 1a, 1b and 2 (Time Frame - first: 18 months after inclusion of first patient, afterwards annually up to 10 years):
according a preselection out of CTC3

5. OS (Stratum 2) (Time Frame - first: 18 months after inclusion of first patient, afterwards annually up to 10 years):
The primary endpoint is the OS calculated from the date of the recruitment . Death from any cause will be considered an event.

Studien-Arme

  • Experimental: Flu/Thio/Treo
    Fludarabine/Thiotepa/Treosulfan is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients with: MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon. MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon. MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide
  • Active Comparator: TBI/VP16
    TBI (Total Body Irradiation) / VP16 is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients older than 48 months with: MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon. MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon. MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide. Patients aged 24-48 months may optionally receive Total Body Irradiation (TBI).
  • Experimental: Flu/Thio/ivBu
    Fludarabine/Thiotepa/iV Busulfan is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients with: MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon. MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon. MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide
  • Experimental: Bu/VP16/Cy
    Busulfan/VP16/Cyclophosphamide is an alternative conditioning arm that may optionally be used for HSCT with MSD/MD and MMD graft in patients aged 0-24 months. Patients undergoing MD HSCT will also receive ATG Thymo- or Grafalon.

Geprüfte Regime

  • VP16 (Etoposide):
    60 mg/kg BW,1 day in TBI/VP16 conditioning; 40 mg/kg BW in Bu/VP16/Cy conditioning
  • TBI:
    2 x 2Gy/day , 3 days (total 12Gy)
  • Thiotepa (Thio):
    2x5 mg/kg BW, 1 day
  • Treosulfan (Treo):
    14g/m² BS, 3 days
  • Fludarabine (Flu):
    30 mg/m² BS, 5 days
  • Busulfan (Bu):
    iV, dosage according therapeutic drug monitoring, 4 days
  • ATG Thymoglobulin (ATG Thymo):
    MD: ATG Thymo: 2,5mg/kg BW/d 3 days.
  • Cyclophosphamide (Cy):
    as part of conditioning 60 mg/kg BW 2 days or as GvHD Prophylaxis 50mg/kg BW/d 2 days with Mesna
  • Grafalon (Anti-human T-lymphocyte immunoglobulin):
    MD: 15mg/kg BW/d 3 days MMD: 10mg/kg BW/d 3 days

Quelle: ClinicalTrials.gov


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