International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

NCT04043494 | Recruiting Phase 3 DMC

• 2 other identifiers: UKM17_00232017-001691-39
• Study Type: interventional
• Target: 683
• Locations: 21 countries
• Sites: 228

Brief Summary

Primary objectives:

• Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm)
• Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02)

Conditions

Lymphoblastic Lymphoma, Childhood

Outcome Measures

Primary Outcomes (2)

• Cumulative incidence of relapse with involvement of the CNS (CNS-relapse, pCICR)

  The time to relapse is defined as the time from randomization to the first relapse or the date of last follow-up. Other events (non-response, progressive disease, relapse, second malignancy or death before and in CR) will be taken into account as competing events.

  through study completion, maximal 7.25 years

• Estimated probability of event-free survival (pEFS)

  The pEFS is defined as the time from randomization to the first event (non-response, progressive disease, relapse, second malignancy or death from any cause) or date of last follow-up.

  through study completion, maximal 7.25 years

Secondary Outcomes (7)

• Survival (pOS)

  through study completion, maximal 7.25 years

• Frequency of treatment-related toxicity overall and in specific protocol elements, randomized arms and during follow up

  through study completion, maximal 7.25 years

• Frequency of treatment-related mortality overall and in specific protocol elements, randomized arms and during follow up

  through study completion, maximal 7.25 years

• Frequency of adverse events of interest and severe adverse events overall

  through study completion, maximal 7.25 years

• Rate of evaluable patients for risk group stratification

  during recruitment

Study Arms (8)

SR I/II: R1 into protocol Ia-Pred

OTHER

1. cytoreductive prephase with prednisone 2. standard induction phase (protocol Ia-prednisone) 3. consolidation phase (protocol Ib) 4. non-HR extra-compartment phase (protocol M) 5. maintenance therapy

Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Daunorubicin; Drug: 6-Mercaptopurine; Drug: Methotrexate; Drug: PEG asparaginase; Drug: Prednisone; Drug: Prednisolone; Drug: Vincristine

SR I/II: R1 into protocol Ia-Dexa

EXPERIMENTAL

1. cytoreductive prephase with prednisone 2. experimental induction phase (protocol Ia-dexamethasone) 3. consolidation phase (protocol Ib) 4. non-HR extra-compartment Phase (protocol M) 5. maintenance therapy

Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Daunorubicin; Drug: 6-Mercaptopurine; Drug: Methotrexate; Drug: PEG asparaginase; Drug: Prednisone; Drug: Prednisolone; Drug: Vincristine

SR: R1 into protocol Ia-Pred

OTHER

1. cytoreductive prephase with prednisone 2. standard induction phase (protocol Ia-prednisone) 3. consolidation phase (protocol Ib) 4. non-HR extra-compartment phase (protocol M) 5. reintensification phase (protocol II) 6. maintenance therapy

Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Daunorubicin; Drug: Doxorubicin; Drug: 6-Mercaptopurine; Drug: Methotrexate; Drug: PEG asparaginase; Drug: Prednisone; Drug: Prednisolone; Drug: Thioguanine; Drug: Vincristine

SR: R1 into protocol Ia-Dexa

EXPERIMENTAL

1. cytoreductive prephase with prednisone 2. experimental induction phase (protocol Ia-dexamethasone) 3. consolidation phase (protocol Ib) 4. non-HR extra-compartment phase (protocol M) 5. reintensification phase (protocol II) 6. maintenance therapy

Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Daunorubicin; Drug: Doxorubicin; Drug: 6-Mercaptopurine; Drug: Methotrexate; Drug: PEG asparaginase; Drug: Prednisone; Drug: Prednisolone; Drug: Thioguanine; Drug: Vincristine

HR: R1 into "Pred" and R2 into non-HR extra-compartment phase

OTHER

1. cytoreductive prephase with prednisone 2. standard induction phase (protocol Ia-prednisone) 3. consolidation phase (protocol Ib) 4. non-HR extra-compartment phase (protocol M) 5. reintensification phase (protocol II) 6. maintenance therapy

Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Daunorubicin; Drug: Doxorubicin; Drug: 6-Mercaptopurine; Drug: Methotrexate; Drug: PEG asparaginase; Drug: Prednisone; Drug: Prednisolone; Drug: Thioguanine; Drug: Vincristine

HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase

EXPERIMENTAL

1. cytoreductive prephase with prednisone 2. experimental induction phase (protocol Ia-dexamethasone) 3. consolidation phase (protocol Ib) 4. non-HR extra-compartment phase (protocol M) 5. reintensification phase (protocol II) 6. maintenance therapy

Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Daunorubicin; Drug: Doxorubicin; Drug: 6-Mercaptopurine; Drug: Methotrexate; Drug: PEG asparaginase; Drug: Prednisone; Drug: Prednisolone; Drug: Thioguanine; Drug: Vincristine

HR: R1 into "Pred" and R2 into HR extra-compartment phase

EXPERIMENTAL

1. cytoreductive prephase with prednisone 2. standard induction phase (protocol Ia-prednisone) 3. consolidation phase (protocol Ib\*) 4. HR extra-compartment phase (intensified protocol M) 5. reintensification phase (protocol II) 6. maintenance therapy

Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Daunorubicin; Drug: Doxorubicin; Drug: Ifosfamide; Drug: 6-Mercaptopurine; Drug: Methotrexate; Drug: PEG asparaginase; Drug: Prednisone; Drug: Prednisolone; Drug: Thioguanine; Drug: Vincristine; Drug: Vindesine

HR: R1 into "Dexa" and R2 into HR extra-compartment phase

EXPERIMENTAL

1. cytoreductive prephase with prednisone 2. experimental induction phase (protocol Ia-dexamethasone) 3. consolidation phase (protocol Ib\*) 4. HR extra-compartment phase (intensified protocol M) 5. reintensification phase (protocol II) 6. maintenance therapy

Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Daunorubicin; Drug: Doxorubicin; Drug: Ifosfamide; Drug: 6-Mercaptopurine; Drug: Methotrexate; Drug: PEG asparaginase; Drug: Prednisone; Drug: Prednisolone; Drug: Thioguanine; Drug: Vincristine; Drug: Vindesine

Interventions

Cyclophosphamide DRUG

Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase; HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase; HR: R1 into "Pred" and R2 into HR extra-compartment phase; HR: R1 into "Pred" and R2 into non-HR extra-compartment phase; SR I/II: R1 into protocol Ia-Dexa; SR I/II: R1 into protocol Ia-Pred; SR: R1 into protocol Ia-Dexa; SR: R1 into protocol Ia-Pred

Cytarabine DRUG

No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2). Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase; HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase; HR: R1 into "Pred" and R2 into HR extra-compartment phase; HR: R1 into "Pred" and R2 into non-HR extra-compartment phase; SR I/II: R1 into protocol Ia-Dexa; SR I/II: R1 into protocol Ia-Pred; SR: R1 into protocol Ia-Dexa; SR: R1 into protocol Ia-Pred

Dexamethasone DRUG

Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase; HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase; HR: R1 into "Pred" and R2 into HR extra-compartment phase; HR: R1 into "Pred" and R2 into non-HR extra-compartment phase; SR I/II: R1 into protocol Ia-Dexa; SR: R1 into protocol Ia-Dexa; SR: R1 into protocol Ia-Pred

Daunorubicin DRUG

Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase; HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase; HR: R1 into "Pred" and R2 into HR extra-compartment phase; HR: R1 into "Pred" and R2 into non-HR extra-compartment phase; SR I/II: R1 into protocol Ia-Dexa; SR I/II: R1 into protocol Ia-Pred; SR: R1 into protocol Ia-Dexa; SR: R1 into protocol Ia-Pred

Doxorubicin DRUG

Part of standard chemotherapy

HR: R1 into "Dexa" and R2 into HR extra-compartment phase; HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase; HR: R1 into "Pred" and R2 into HR extra-compartment phase; HR: R1 into "Pred" and R2 into non-HR extra-compartment phase; SR: R1 into protocol Ia-Dexa; SR: R1 into protocol Ia-Pred

Ifosfamide DRUG

Part of the experimental therapy in Randomization R2 (Intensified Protocol M)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase; HR: R1 into "Pred" and R2 into HR extra-compartment phase

6-Mercaptopurine DRUG

Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase; HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase; HR: R1 into "Pred" and R2 into HR extra-compartment phase; HR: R1 into "Pred" and R2 into non-HR extra-compartment phase; SR I/II: R1 into protocol Ia-Dexa; SR I/II: R1 into protocol Ia-Pred; SR: R1 into protocol Ia-Dexa; SR: R1 into protocol Ia-Pred

Methotrexate DRUG

Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase; HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase; HR: R1 into "Pred" and R2 into HR extra-compartment phase; HR: R1 into "Pred" and R2 into non-HR extra-compartment phase; SR I/II: R1 into protocol Ia-Dexa; SR I/II: R1 into protocol Ia-Pred; SR: R1 into protocol Ia-Dexa; SR: R1 into protocol Ia-Pred

PEG asparaginase DRUG

Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib\* (Randomization R2)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase; HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase; HR: R1 into "Pred" and R2 into HR extra-compartment phase; HR: R1 into "Pred" and R2 into non-HR extra-compartment phase; SR I/II: R1 into protocol Ia-Dexa; SR I/II: R1 into protocol Ia-Pred; SR: R1 into protocol Ia-Dexa; SR: R1 into protocol Ia-Pred

Prednisone DRUG

Part of standard chemotherapy

HR: R1 into "Dexa" and R2 into HR extra-compartment phase; HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase; HR: R1 into "Pred" and R2 into HR extra-compartment phase; HR: R1 into "Pred" and R2 into non-HR extra-compartment phase; SR I/II: R1 into protocol Ia-Dexa; SR I/II: R1 into protocol Ia-Pred; SR: R1 into protocol Ia-Dexa; SR: R1 into protocol Ia-Pred

Prednisolone DRUG

No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2

HR: R1 into "Dexa" and R2 into HR extra-compartment phase; HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase; HR: R1 into "Pred" and R2 into HR extra-compartment phase; HR: R1 into "Pred" and R2 into non-HR extra-compartment phase; SR I/II: R1 into protocol Ia-Dexa; SR I/II: R1 into protocol Ia-Pred; SR: R1 into protocol Ia-Dexa; SR: R1 into protocol Ia-Pred

Thioguanine DRUG

Part of standard chemotherapy

HR: R1 into "Dexa" and R2 into HR extra-compartment phase; HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase; HR: R1 into "Pred" and R2 into HR extra-compartment phase; HR: R1 into "Pred" and R2 into non-HR extra-compartment phase; SR: R1 into protocol Ia-Dexa; SR: R1 into protocol Ia-Pred

Vincristine DRUG

Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase; HR: R1 into "Dexa" and R2 into non-HR extra-compartment phase; HR: R1 into "Pred" and R2 into HR extra-compartment phase; HR: R1 into "Pred" and R2 into non-HR extra-compartment phase; SR I/II: R1 into protocol Ia-Dexa; SR I/II: R1 into protocol Ia-Pred; SR: R1 into protocol Ia-Dexa; SR: R1 into protocol Ia-Pred

Vindesine DRUG

Part of the experimental therapy in Randomization R2 (Intensified Protocol M)

HR: R1 into "Dexa" and R2 into HR extra-compartment phase; HR: R1 into "Pred" and R2 into HR extra-compartment phase

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• newly diagnosed lymphoblastic lymphoma
• age \<18 years
• patient enrolled in a participating center
• written informed consent of patient (\>14 years of age or according to local law and regulation) and parents to trial participation and transfer and processing of data
• willingness of patients and the investigator/pathologist to provide adequate slides/blocks for reference (molecular) pathology and international pathology panel and/or fresh or fresh frozen samples for genetic risk group stratification if these samples are available after standard diagnostic procedures.

You may not qualify if:

• lymphoblastic lymphoma as secondary malignancy
• non-lymphoma related relevant medical, psychiatric or social conditions incompatible with trial treatment, including among others
• prior organ transplant
• severe immunodeficiency
• demyelinating Charcot-Marie Tooth syndrome
• serious acute or chronic infections, such as HIV, VZV and tuberculosis
• urinary tract infection, cystitis, urinary outflow obstruction, severe renal impairment (creatinine clearance less than 20 ml/min)
• severe hepatic impairment (bilirubin \>3 times ULN, transaminases \>10 times ULN)
• myocardial insufficiency, severe arrhythmias
• ulcers of the oral cavity and known active gastrointestinal ulcer disease
• known hypersensitivity to any IMP and to any excipient (listed in section 6.1 of the respective SmPC)
• steroid pre-treatment with ≥ 1 mg/kg/d for more than two weeks during the last month before diagnosis
• vaccination with live vaccines within 2 weeks before start of protocol treatment
• treatment started according to another protocol or pre-treatment with cytostatic drugs
• participation in another clinical trial that interferes with the protocol, except NHL-BFM Registry 2012 and trials with different endpoints, involving aspects of supportive treatment, which can run parallel to LBL 2018 without influencing the outcome of this trial (e.g. trials on antiemetics, antibiotics, strategies for psychosocial support)

Sponsors & Collaborators

• Deutsche Krebshilfe e.V., Bonn (Germany): collaborator
• University Hospital Muenster: lead

Study Sites (228)

Univ.Klinik für Kinder- und Jugendheilkunde Graz, Klin. Abteilung für pädiatrische Hämato-Onkologie

Graz, 8036, Austria

RECRUITING

Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck, Universitätsklinik für Pädiatrie I

Innsbruck, 6020, Austria

RECRUITING

Kepler Universitätsklinikum, Med Campus IV / Onkologie

Linz, 4020, Austria

RECRUITING

LKH Salzburg, Universitätsklinik für Kinder- und Jugendheilkunde, Kinderonkologie

Salzburg, 5020, Austria

RECRUITING

St. Anna Kinderspital

Vienna, 1090, Austria

RECRUITING

Hôpital Universitaire des Enfants Reine Fabiola (ULB), Pédiatrie hémato-oncologie

Brussels, 1020, Belgium

RECRUITING

University Hospital Brussels, Pediatrische oncologie

Brussels, 1090, Belgium

RECRUITING

Cliniques Universitaires Saint-Luc (UCL), Hématologie et oncologie pédiatrique

Brussels, 1200, Belgium

RECRUITING

UZ Antwerpen Kinderhemato-oncologie

Edegem, 2650, Belgium

RECRUITING

University Hospital Gent Pediatrische hemato-oncologie

Ghent, 9000, Belgium

RECRUITING

University Hospitals Leuven, Kinderhemato-oncologie

Leuven, 3000, Belgium

RECRUITING

CHR Citadelle Hémato - oncologie pédiatrique

Liège, 4000, Belgium

RECRUITING

CHR Citadelle Hémato - oncologie pédiatrique

Montegnée, 4000, Belgium

RECRUITING

Hong Kong Children's Hospital

Hong Kong, China

RECRUITING

Dept. of Pediatric Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University Cernopolni

Brno, 662 63, Czechia

RECRUITING

Dept. of Pediatric Hematology and Oncology. University Hospital Motol and 2nd Medical School, Charles University

Prague, 160 06, Czechia

RECRUITING

University Hospital Aalborg, Nord, Department of Pediatrics

Aalborg, 9000, Denmark

RECRUITING

Aarhus University Hospital, Department of Pediatrics

Aarhus, 8200, Denmark

RECRUITING

Børneonkologisk afsnit 5054, BørneUngeKlinikken, Juliane Marie Centret, Rigshospitalet

Copenhagen, 2100 Ø, Denmark

RECRUITING

H.C. Andersens Children Hospital, Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Helsinki University Hospital, Department of Pediatric Hematology and Oncology

Helsinki, 00029 HUS, Finland

RECRUITING

Kuopio University Hospital, Department of Pediatric Hematology and Oncology

Kuopio, 70029 KYS, Finland

RECRUITING

University Hospital of Oulu, Paediatric Haematology and Oncology

Oulu, 90029 OYS, Finland

RECRUITING

Tampere University Hospital, Paediatric Haematology and Oncology

Tampere, 33521 Tampere, Finland

RECRUITING

Turku University Hospital, Paediatric and Adolescent Haematology and Oncology

Turku, 20521 Turku, Finland

RECRUITING

Service d'oncolologie, Hématologie pédiatrique. CHU Amiens, Avenue René Laënnec - SALOUEL

Amiens, 80054, France

NOT YET RECRUITING

Pôle Femme Mère Enfant ; Unité d'Hématologie/Oncologie pédiatrique, CHU Angers

Angers, 49033, France

NOT YET RECRUITING

Hématologie Oncologie pédiatrique, CHRU Besançon

Besançon, 25030, France

NOT YET RECRUITING

Hôpital de Enfants, Unité Onco-Hématologie Pédiatrique, Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

NOT YET RECRUITING

Département de Pédiatrie et Génétique Médicale CHRU Morvan

Brest, 29609, France

NOT YET RECRUITING

Unité d'hémato-immuno-oncologie pédiatrique. Centre Hospitalier Universitaire niveau 1 - bâtiment FEH

Caen, 14033, France

NOT YET RECRUITING

Unité Onco- Hématologie Pédiatrique CHU Estaing 1 place Lucie-Aubrac

Clermont-Ferrand, 63303, France

NOT YET RECRUITING

Service Immuno-Hématologie Oncologie Pédiatrique

Dijon, 21079, France

NOT YET RECRUITING

Service onco hématologie pédiatrique CHU de Grenoble site Nord - Hôpital Couple enfant

Grenoble, 38043, France

NOT YET RECRUITING

Unité d'hématologie pédiatrique CHRU de Lille - Hôpital Jeanne de Flandre

Lille, 59037, France

NOT YET RECRUITING

Service d'Hématologie - Oncologie pédiatrique CHU Limoges - Hôpital de la mère et de l'enfant

Limoges, 87042, France

NOT YET RECRUITING

Service d'immuno-hématologie pédiatrique et de transplantation de moelle osseuse, CHU de Lyon HCL - GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP

Lyon, 69373, France

NOT YET RECRUITING

Service de Pédiatrie et hématologie pédiatrique, CHU de Marseille - Hôpital de la Timone

Marseille, 13385, France

NOT YET RECRUITING

UAM Hématologie et Oncologie Pédiatrique, CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

NOT YET RECRUITING

Service d'hématologie et oncologie pédiatriques, Hôpital enfant-adolescent, CHU NANTES

Nantes, 44093, France

NOT YET RECRUITING

Service d'hémato-oncologie pédiatrique CHU NICE - Hôpital l'Archet 2

Nice, 06200, France

NOT YET RECRUITING

service d'oncologie pédiatrique, institut Curie

Paris, 75005, France

NOT YET RECRUITING

Service Hémato-immuno- oncologie- CHU PARIS Armand Trousseau

Paris, 75012, France

NOT YET RECRUITING

Service d' hémato-immunologie CHU Paris - Hôpital Robert Debré

Paris, 75019, France

NOT YET RECRUITING

Service Oncologie-Hématologie pédiatrique CHU de Poitiers

Poitiers, 86000, France

NOT YET RECRUITING

Service d'Hémato-Oncologie Pédiatrique- American Hospital

Reims, 51100, France

NOT YET RECRUITING

Pôle pédiatrie Hémato-cancérologie pédiatrique- CHU RENNES - Hôpital sud

Rennes, 35203, France

NOT YET RECRUITING

Service d'Hemato-Oncologie Pediatrique CHU Rouen

Rouen, 76031, France

NOT YET RECRUITING

service d'oncologie pédiatrique, hopital Félix Guyon

Saint-Denis, 97405, France

NOT YET RECRUITING

Pôle mère enfant-Unité Hématologie - Oncologie pédiatrique - CHU Hôpital NORD

Saint-Priest-en-Jarez, 42270, France

NOT YET RECRUITING

Service d'Onco-Hematologie Pediatrique CHU STRASBOURG -Hôpital de Hautepierre

Strasbourg, 67098, France

NOT YET RECRUITING

Service Pédiatrie - Hématologie Immunologie Oncologie - CHU Toulouse

Toulouse, 31059, France

NOT YET RECRUITING

Service d'hémato-oncologie pédiatrique- CHU de Nancy - Hôpital de Brabois Enfant

Vandœuvre-lès-Nancy, 54511, France

NOT YET RECRUITING

Dépt de Pédiatrie Gustave Roussy

Villejuif, 94805, France

NOT YET RECRUITING

Universitätsklinikum Aachen .Klinik für Kinder - und Jugendmedizin Hämatologie / Onkologie

Aachen, 52057, Germany

RECRUITING

Klinikum Augsburg ,Schwäbisches Kinderkrebszentrum. I. Klinik für Kinder und Jugendliche Hämatologie / Onkologie

Augsburg, 86156, Germany

RECRUITING

HELIOS Klinikum Berlin-Buch, Kinderklinik, Pädiatrische Hämatologie und Onkologie

Berlin, 13125, Germany

RECRUITING

Charité Campus Virchow-Klinikum, Zentrum für Kinder- und Jugendmedizin- Abt. Hämatologie / Onkologie

Berlin, 13353, Germany

RECRUITING

Evangelisches Krankenhaus Bielefeld GmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie

Bielefeld, 33617, Germany

RECRUITING

Zentrum für Kinderheilkunde der Universität Bonn, Abt. Päd. Hämatologie / Onkologie

Bonn, 55113, Germany

RECRUITING

Städtisches Klinikum Braunschweig gGmbH, Zentrum für Kinder- und Jugendmedizin

Braunschweig, 38126, Germany

RECRUITING

Klinikum Bremen-Mitte gGmbH, Prof.-Hess-Kinderklinik,Pädiatrische Onkologie und Hämatologie

Bremen, 28177, Germany

RECRUITING

Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie

Chemnitz, 09116, Germany

NOT YET RECRUITING

Klinikum der Universität zu Köln, Klinik für Kinder- und Jugendmedizin, Abt. Kinderonkologie und -hämatologie

Cologne, 50924, Germany

NOT YET RECRUITING

Carl-Thiem-Klinikum, Kinderklinik, Station 5e

Cottbus, 03048, Germany

RECRUITING

Vestische Kinderklinik, Universität Witten / Herdecke

Datteln, 45711, Germany

RECRUITING

Klinikum Dortmund gGmbH, Klinik für Kinder- und Jugendmedizin, Station K1, Abt. Päd. Onkologie / Hämatologie

Dortmund, 44137, Germany

RECRUITING

Universitätsklinik Carl Gustav Carus der TU Dresden, Klinik für Kinder- und Jugendmedizin

Dresden, 01307, Germany

RECRUITING

Universitätsklinikum Düsseldorf, Zentrum für Kinder- und Jugendmedizin, Klinik für Päd. Hämatologie und Onkologie

Düsseldorf, 40225, Germany

RECRUITING

HELIOS Klinikum Erfurt GmbH, Klinik für Kinder- und Jugendmedizin, Päd. Onkologie / Hämatologie

Erfurt, 99089, Germany

RECRUITING

Universitätsklinikum Erlangen, Klinik für Kinder- und Jugendmedizin, Pädiatrische Onkologie / Hämatologie

Erlangen, 91054, Germany

RECRUITING

Universitätsklinikum Essen, Zentrum für Kinder- und Jugendmedizin, Hämatologie / Onkologie

Essen, 45122, Germany

RECRUITING

Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie

Frankfurt, 60590, Germany

RECRUITING

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

Freiburg im Breisgau, 79106, Germany

RECRUITING

Universitätsklinikum Gießen und Marburg, Standort Gießen, Zentrum für Kinderhämatologie und -onkologie

Giessen, 35385, Germany

RECRUITING

Georg-August-Universität Universitäts-Kinderklinik, Pädiatrie I

Göttingen, 37075, Germany

RECRUITING

Universitätsklinikum Greifswald KdöR, Klinik und Poliklinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Onkologie und Hämatologie

Greifswald, 17475, Germany

RECRUITING

Universitätsklinikum Halle (Saale), Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie

Halle, 06120, Germany

RECRUITING

Universitätsklinikum Hamburg Eppendorf, Zentrum für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie

Hamburg, 20246, Germany

RECRUITING

Medizinische Hochschule Hannover, Kinderheilkunde, Päd. Hämatologie / Onkologie

Hanover, 30625, Germany

RECRUITING

Universitäts-Kinderklinik Heidelberg, Abt. Hämatologie / Onkologie

Heidelberg, 69120, Germany

RECRUITING

Gemeinschaftskrankenhaus Herdecke, Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie

Herdecke, 58313, Germany

RECRUITING

Universitätskliniken für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie, Geb. 9

Homburg, 66421, Germany

RECRUITING

Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin

Jena, 07745, Germany

RECRUITING

Städtisches Klinikum Karlsruhe gGmbH, Kinderklinik, Station S 24

Karlsruhe, 76133, Germany

RECRUITING

Klinikum Kassel Gesundheit Nordhessen Holding AG, Klinik für pädiatrische Hämatologie und Onkologie

Kassel, 34125, Germany

RECRUITING

Universitätsklinikum Schleswig Holstein Campus Kiel, Klinik für Allgemeine Pädiatrie, Päd. Onkologie / Hämatologie

Kiel, 24105, Germany

RECRUITING

Gemeinschaftsklinikum Mittelrhein Kemperhof, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie

Koblenz, 56073, Germany

RECRUITING

HELIOS Klinikum Krefeld, Zentrum für Kinder- und Jugendmedizin, Päd. Hämatologie/Onkologie

Krefeld, 47805, Germany

RECRUITING

Universitätsklinikum Leipzig, Klinik für Kinder und Jugendliche, Abt. Päd. Hämatologie / Onkologie

Leipzig, 04103, Germany

RECRUITING

Universitätsklinikum Schleswig Holstein Campus Lübeck, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie

Lübeck, 23538, Germany

RECRUITING

Universitätsklinikum Magdeburg A. ö. R., Kinderklinik, Päd. Hämatologie / Onkologie

Magdeburg, 39120, Germany

RECRUITING

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Zentrum für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie

Mainz, 55101, Germany

RECRUITING

Klinikum Mannheim gGmbH, Universitäts-Kinderklinik, Päd. Onkologie /Hämatologie

Manheim, 68167, Germany

RECRUITING

Johannes Wesling Klinikum Minden, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie, Station E 22

Minden, 32429, Germany

RECRUITING

Klinikum der LMU, Dr. von Haunersches Kinderspital, Pädiatrische Hämatologie / Onkologie

München, 80337, Germany

RECRUITING

Klinikum Schwabing, Kinderklinik der TU Päd. Hämatologie / Onkologie, Station 24d

München, 80804, Germany

RECRUITING

Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie

Münster, 48149, Germany

RECRUITING

Diakonie Neuendettelsau, Kliniken Hallerwiese / Cnopf'sche Kinderklinik, Pädiatrische Hämatologie /Onkologie

Nuremberg, 90419, Germany

RECRUITING

Klinikum Oldenburg AöR, Zentrum für Kinder- und Jugendmedizin, Abt. Hämatologie / Onkologie

Oldenburg, 26133, Germany

RECRUITING

Universitätsklinikum Regensburg, Klinik für Kinder- und Jugendmedizin, Abt. Päd. Hämatologie, Onkologie, SZT

Regensburg, 93053, Germany

RECRUITING

Universitätsklinikum Rostock, Kinder- und Jugendklinik, Päd. Hämatologie und Onkologie

Rostock, 18057, Germany

RECRUITING

Asklepios Klinik St. Augustin GmbH, Kinder- und Jugendmedizin, Kinder-Hämatologie und Onkologie

Sankt Augustin, 53757, Germany

RECRUITING

HELIOS Kliniken Schwerin GmbH, Klinik für Kinder- und Jugendmedizin, Station A1

Schwerin, 19049, Germany

RECRUITING

Klinikum Stuttgart, Olgahospital Zentrum für Kinder- und Jugendmedizin Pädiatrie 5 (Onkologie, Hämatologie, Immunologie)

Stuttgart, 70174, Germany

RECRUITING

Klinikum Mutterhaus der Borromäerinnen gGmbH, Pädiatrische Abteilung

Trier, 54290, Germany

WITHDRAWN

Universitätsklinik Tübingen, Klinik für Kinderheilkunde und Jugendmedizin, Päd. Hämatologie / Onkologie

Tübingen, 72076, Germany

RECRUITING

Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie

Ulm, 89081, Germany

RECRUITING

Universitätskinderklinik Würzburg, Päd. Onkologie und Hämatologie

Würzburg, 97080, Germany

RECRUITING

2nd Dep. of Pediatrics, Semmelweis Univ

Budapest, Hungary

NOT YET RECRUITING

Heim Pal Children Hospital

Budapest, Hungary

NOT YET RECRUITING

Dep. of Pediatrics, Univ. of Debrecen

Debrecen, Hungary

NOT YET RECRUITING

Children's Treating Center, Miskolc

Miskolc, Hungary

NOT YET RECRUITING

Dep. of Pediatrics, University of Pecs

Pécs, Hungary

NOT YET RECRUITING

Dep. of Pediatrics, Univ. of Szeged

Szeged, Hungary

NOT YET RECRUITING

Our Lady's Children's Hospital Crumlin

Dublin, Ireland

NOT YET RECRUITING

Children's Hospital at Soroka Medical Center

Beersheba, Israel

NOT YET RECRUITING

Ruth Rappaport Children's Hospital, Rambam Medical Center

Haifa, Israel

NOT YET RECRUITING

Children's Hospital at Hadassah, Ein Kerem Medical Center

Jerusalem, Israel

NOT YET RECRUITING

Schneider Children's hospital, Rabin Medical Center

Petah Tikva, Israel

NOT YET RECRUITING

Edmond and Lily Safra Children's Hospital, Sheba Medical Center

Ramat Gan, Israel

NOT YET RECRUITING

Dana Children's Hospital, Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

NOT YET RECRUITING

Azienda Ospedaliero Universitaria Delle Marche

Ancona, 60126, Italy

NOT YET RECRUITING

University Hospital Consorziale Policlinico

Bari, 70124, Italy

RECRUITING

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, 24127, Italy

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria Di Bologna IRCCS

Bologna, 40138, Italy

RECRUITING

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Brescia, 25123, Italy

RECRUITING

ARNAS G. Brotzu

Cagliari, 09121, Italy

RECRUITING

Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania

Catania, 95123, Italy

NOT YET RECRUITING

University Hospital Of Ferrara

Cona, 44124, Italy

NOT YET RECRUITING

U. O. di Pediatria- Azienda Ospedaliera Annunziata

Cosenza, 87100, Italy

WITHDRAWN

Dipartimento di Medicina Clinica e Sperimentale Sezione di Pediatria - Università di Ferrara

Ferrara, 44100, Italy

WITHDRAWN

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence, 50139, Italy

RECRUITING

Giannina Gaslini Institute For Scientific Hospitalization And Care

Genova, 16147, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

Azienda Ospedaliero Universitaria di Modena

Modena, 41124, Italy

WITHDRAWN

Fondazione IRCCS San Gerardo Dei Tintori

Monza, 20900, Italy

RECRUITING

S.C. Ematologia Oncologica- Ospedale "Pausilipon"

Naples, 80123, Italy

WITHDRAWN

L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon

Naples, 80129, Italy

RECRUITING

Azienda Ospedale-Università Padova

Padova, 35128, Italy

RECRUITING

ARNAS Civico Di Cristina Benfratelli

Palermo, 90127, Italy

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria di Parma

Parma, 43126, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana

Perugia, 06129, Italy

NOT YET RECRUITING

Azienda Sanitaria Locale Di Pescara

Pescara, 65124, Italy

NOT YET RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

RECRUITING

Azienda Unità Sanitaria della Romagna

Rimini, 48121, Italy

RECRUITING

Sezione Ematologia- Dipart. Biotecnico Cellulare ed Ematologia- Università "La Sapienza"

Roma, 00161, Italy

WITHDRAWN

Ospedale Pediatrico Bambino Gesù

Roma, 00165, Italy

NOT YET RECRUITING

Casa Sollievo Della Sofferenza

San Giovanni Rotondo, 71013, Italy

RECRUITING

Oncologia Pediatrica,- Ospedale "R. Silvestrini"

San Sisto, 06080, Italy

WITHDRAWN

Azienda Ospedaliera Universitaria Città Della Salute E Della Scienza Di Torino

Torino, 10126, Italy

RECRUITING

Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo

Trieste, 34137, Italy

RECRUITING

Azienda Socio Sanitaria Territoriale Dei Sette Laghi

Varese, 21100, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, 37126, Italy

RECRUITING

Princess Maxima Centre for Pediatric Oncology

Utrecht, 3584CS, Netherlands

NOT YET RECRUITING

Haukeland University Hospital in Bergen

Bergen, Norway

RECRUITING

University Hospital Northern Norway

Tromsø, Norway

RECRUITING

St Olavs Hospital in Trondheim

Trondheim, Norway

RECRUITING

Department of Pediatric Oncology and Hematology, Medical University of Bialystok

Bialystok, 15-247, Poland

NOT YET RECRUITING

Department of Pediatric Hematology and Oncology, Nicolaus Copernicus University

Bydgoszcz, 85-094, Poland

NOT YET RECRUITING

Department of Pediatric Hematology and Oncology, Center of Pediatrics and Oncology in Chorzów

Chorzów, 41-500, Poland

NOT YET RECRUITING

Department of Pediatrics, Hematology, Oncology and Endocrinology, Medical University of Gdansk

Gdansk, 20-211, Poland

NOT YET RECRUITING

Department of Pediatric Oncology and Hematology, Center of Pediatrics in Kielce

Kielce, 25-736, Poland

NOT YET RECRUITING

Department of Pediatric Oncology/Hematology, Institute of Pediatrics, Medical College Jagiellonian University

Krakow, 30-663, Poland

NOT YET RECRUITING

Department of Pediatrics, Oncology, Hematology and Diabetology, Institute of Pediatrics, Medical University of Lodz

Lodz, 91-138, Poland

NOT YET RECRUITING

Department of Pediatric Hematology, Oncology and Transplantology, Medical University of Lublin

Lublin, 20-093, Poland

NOT YET RECRUITING

Department of Pediatric Oncology and Hematology, Provincial Specialist Children's Hospital

Olsztyn, 10-561, Poland

NOT YET RECRUITING

Department of Pediatric Oncology, Hematology and Transplantology, Poznan University of Medical Sciences

Poznan, 60-572, Poland

NOT YET RECRUITING

Department of Paediatric Oncology and Haematology, University of Rzeszów, Department of Pediatrics

Rzeszów, 35-301, Poland

NOT YET RECRUITING

Department of Pediatrics, Children Hematology nad Oncology, Pomeranian Medical University

Szczecin, 71-242, Poland

NOT YET RECRUITING

Department of Pediatrics, Hematology and Oncology, Medical University of Warsaw

Warsaw, 00-576, Poland

NOT YET RECRUITING

Department of Pediatric Oncology, Children's Memorial Health Institute

Warsaw, 04-576, Poland

NOT YET RECRUITING

Department of Bone Marrow Transplantation, Children Oncology and Hematology, Wroclaw Medical University

Wroclaw, 50-556, Poland

NOT YET RECRUITING

Department of Pediatric Hematology and Oncology, Silesian Medical University in Katowice

Zabrze, 41-800, Poland

NOT YET RECRUITING

Centro Hospitalar e Universitário de Coimbra

Coimbra, 3000-602, Portugal

NOT YET RECRUITING

Instituto Português de Oncologia - Francisco Gentil - Libosa

Lisbon, 1099-023, Portugal

NOT YET RECRUITING

Instituto Português de Oncologia - Francisco Gentil - Porto

Porto, 4200-072, Portugal

NOT YET RECRUITING

National Center for Pediatric Hematology, Oncology and Immunology Moscow

Moscow, 117198, Russia

RECRUITING

Oncological center of regional Children's Hospital

Yekaterinburg, Russia

RECRUITING

Department of pediatric oncology and hematology, Children´s Faculty Hospital

Banská Bystrica, 974 09, Slovakia

NOT YET RECRUITING

Department of pediatric hematology and oncology, National Institute of Children's Diseases

Bratislava, 833 40, Slovakia

NOT YET RECRUITING

Department of pediatric hematology and oncology, Children´s University Hospital

Košice, 04011, Slovakia

NOT YET RECRUITING

Hospital General Universitario de Alicante

Alicante, 03010, Spain

RECRUITING

Hospital Universitario Torrecárdenas

Almería, 04009, Spain

RECRUITING

Hospital Materno-Infantil de Badajoz

Badajoz, 06010, Spain

RECRUITING

Hospital Universitario Cruces

Barakaldo, 48903, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

Hospital Universitario Donostia

Donostia / San Sebastian, 20014, Spain

RECRUITING

Hospital Sant Joan de Déu

Esplugues de Llobregat, 08950, Spain

RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

RECRUITING

Complejo Hospitalario Universitario Insular Materno Infantil

Las Palmas de Gran Canaria, 35016, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

RECRUITING

Hospital Infantil Universitario Niño Jesús

Madrid, 28009, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Regional Universitario de Málaga

Málaga, 29010, Spain

RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

RECRUITING

Hospital Universitari Son Espases

Palma de Mallorca, 07120, Spain

RECRUITING

Hospital Virgen del Camino

Pamplona, 31008, Spain

RECRUITING

Complejo Hospitalario Universitario de Vigo

Pontevedra, 36036, Spain

RECRUITING

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, 38010, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, 390008, Spain

RECRUITING

Hospital Clínico Universitario de Santiago

Santiago de Compostela, 15706, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Hospital Virgen de la Salud

Toledo, 45004, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

RECRUITING

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

RECRUITING

Barncancercentrum, Drottning Silvias Barn och Ungdomssjukhus, Sahlgrenska Universitetssjukhuset

Gothenburg, 416 85, Sweden

RECRUITING

Barnonkologiska enheten, Barn och Ungdomsmedicinska kliniken, Universitetssjukhuset i Linköping

Linköping, 581 85, Sweden

RECRUITING

Barnonkologi, Skåne Universitetssjukhus

Lund, 221 85, Sweden

RECRUITING

Barncanceravdelningen Astrid Lindgrens Barnsjukhus, Nya Karolinska Universitetssjukhuset

Stockholm, 171 76, Sweden

RECRUITING

Barnonkologiska avdelningen, Barn 3, Norrlands Universitetssjukhus

Umeå, 901 85, Sweden

RECRUITING

Barnavdelningen för blod- och tumörsjukdomar 95A, Akademiska sjukhuset

Uppsala, 752 39, Sweden

RECRUITING

Kantonsspital Aarau

Aarau, 5001, Switzerland

NOT YET RECRUITING

Universitäts-Kinderspital beider Basel (UKBB)

Basel, 4056, Switzerland

NOT YET RECRUITING

Ospedale San Giovanni

Bellinzona, 6500, Switzerland

NOT YET RECRUITING

Inselspital Bern, University of Bern

Bern, 3010, Switzerland

NOT YET RECRUITING

HUG Hôpitaux Universitaires de Genève

Geneva, 1211, Switzerland

NOT YET RECRUITING

CHUV - Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

NOT YET RECRUITING

Luzerner Kantonspital - Kinderspital Luzern

Lucerne, 6000, Switzerland

NOT YET RECRUITING

Ostschweizer Kinderspital

Sankt Gallen, 9006, Switzerland

NOT YET RECRUITING

Universitäts-Kinderspital Zürich

Zurich, 8032, Switzerland

NOT YET RECRUITING

Related Publications (1)

• Khanam T, Sandmann S, Seggewiss J, Ruether C, Zimmermann M, Norvil AB, Bartenhagen C, Randau G, Mueller S, Herbrueggen H, Hoffmann P, Herms S, Wei L, Woeste M, Wuensch C, Gowher H, Oschlies I, Klapper W, Woessmann W, Dugas M, Burkhardt B. Integrative genomic analysis of pediatric T-cell lymphoblastic lymphoma reveals candidates of clinical significance. Blood. 2021 Apr 29;137(17):2347-2359. doi: 10.1182/blood.2020005381.

  PMID: 33152759 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Cyclophosphamide; Cytarabine; Dexamethasone; Daunorubicin; Doxorubicin; Ifosfamide; Mercaptopurine; Methotrexate; pegaspargase; Prednisone; Prednisolone; Thioguanine; Vincristine; Vindesine

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates; Oxazines; Sulfhydryl Compounds; Sulfur Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Aminopterin; Pterins; Pteridines; Pregnadienediols; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Birgit Burkhardt, Prof. Dr. Dr.

  University Hospital Muenster, Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgit Burkhardt, Prof. Dr. Dr.

CONTACT

+49 251 83 55696; LBL2018@ukmuenster.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: August 2, 2019
• Study Start: August 23, 2019
• Primary Completion (Estimated): April 22, 2030
• Study Completion (Estimated): April 22, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); IE (1); RU (2); SL (3); ES (30); DK (4); SE (6); DE (55); HU (6); CZ (2); FR (29); BE (8); NL (1); AU (5); CH (9); IT (33); PT (3); PL (16); IL (6); NO (3); FI (5)