International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma (NCT04043494) — China Trial Details

Condition(s) studied

Lymphoblastic Lymphoma, Childhood

Investigational drug(s) / intervention(s)

Cyclophosphamide →Cytarabine →Dexamethasone →Daunorubicin →Doxorubicin →Ifosfamide →6-MercaptopurineMethotrexate →PEG asparaginasePrednisone →Prednisolone →ThioguanineVincristine →Vindesine →

Cyclophosphamide: 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)

Cytarabine: 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)

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

Daunorubicin: 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)

Doxorubicin: Part of standard chemotherapy

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

6-Mercaptopurine: 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)

Methotrexate: 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)

PEG asparaginase: 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)

Prednisone: Part of standard chemotherapy

Prednisolone: 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

Thioguanine: Part of standard chemotherapy

Vincristine: 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)

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

Study 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)

Eligibility

Sex

ALL

Min age

—

Max age

18 Years

Healthy volunteers

No

Inclusion criteria: * 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. Exclusion criteria: * 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) * evidence of pregnancy or lactation period * sexually active adolescents not willing to use highly effective contraceptive method (pearl index \< 1) until 12 months after end of cytostatic therapy

Primary outcome measure(s)

Cumulative incidence of relapse with involvement of the CNS (CNS-relapse, pCICR) — through study completion, maximal 7.25 years
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.
Estimated probability of event-free survival (pEFS) — through study completion, maximal 7.25 years
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.

Trial sites (228)

Facility	City	Region	Status
Univ.Klinik für Kinder- und Jugendheilkunde Graz, Klin. Abteilung für pädiatrische Hämato-Onkologie	Graz	Austria	Recruiting
Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck, Universitätsklinik für Pädiatrie I	Innsbruck	Austria	Recruiting
Kepler Universitätsklinikum, Med Campus IV / Onkologie	Linz	Austria	Recruiting
LKH Salzburg, Universitätsklinik für Kinder- und Jugendheilkunde, Kinderonkologie	Salzburg	Austria	Recruiting
St. Anna Kinderspital	Vienna	Austria	Recruiting
Hôpital Universitaire des Enfants Reine Fabiola (ULB), Pédiatrie hémato-oncologie	Brussels	Belgium	Recruiting
University Hospital Brussels, Pediatrische oncologie	Brussels	Belgium	Recruiting
Cliniques Universitaires Saint-Luc (UCL), Hématologie et oncologie pédiatrique	Brussels	Belgium	Recruiting
UZ Antwerpen Kinderhemato-oncologie	Edegem	Belgium	Recruiting
University Hospital Gent Pediatrische hemato-oncologie	Ghent	Belgium	Recruiting
University Hospitals Leuven, Kinderhemato-oncologie	Leuven	Belgium	Recruiting
CHR Citadelle Hémato - oncologie pédiatrique	Liège	Belgium	Recruiting
CHR Citadelle Hémato - oncologie pédiatrique	Montegnée	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	Czechia	Recruiting
Dept. of Pediatric Hematology and Oncology. University Hospital Motol and 2nd Medical School, Charles University	Prague	Czechia	Recruiting
University Hospital Aalborg, Nord, Department of Pediatrics	Aalborg	Denmark	Recruiting
Aarhus University Hospital, Department of Pediatrics	Aarhus	Denmark	Recruiting
Børneonkologisk afsnit 5054, BørneUngeKlinikken, Juliane Marie Centret, Rigshospitalet	Copenhagen	Denmark	Recruiting
H.C. Andersens Children Hospital, Odense University Hospital	Odense	Denmark	Recruiting
Helsinki University Hospital, Department of Pediatric Hematology and Oncology	Helsinki	Finland	Recruiting
Kuopio University Hospital, Department of Pediatric Hematology and Oncology	Kuopio	Finland	Recruiting
University Hospital of Oulu, Paediatric Haematology and Oncology	Oulu	Finland	Recruiting
Tampere University Hospital, Paediatric Haematology and Oncology	Tampere	Finland	Recruiting
Turku University Hospital, Paediatric and Adolescent Haematology and Oncology	Turku	Finland	Recruiting
Service d'oncolologie, Hématologie pédiatrique. CHU Amiens, Avenue René Laënnec - SALOUEL	Amiens	France	Not Yet Recruiting
Pôle Femme Mère Enfant ; Unité d'Hématologie/Oncologie pédiatrique, CHU Angers	Angers	France	Not Yet Recruiting
Hématologie Oncologie pédiatrique, CHRU Besançon	Besançon	France	Not Yet Recruiting
Hôpital de Enfants, Unité Onco-Hématologie Pédiatrique, Groupe Hospitalier Pellegrin	Bordeaux	France	Not Yet Recruiting
Département de Pédiatrie et Génétique Médicale CHRU Morvan	Brest	France	Not Yet Recruiting
Unité d'hémato-immuno-oncologie pédiatrique. Centre Hospitalier Universitaire niveau 1 - bâtiment FEH	Caen	France	Not Yet Recruiting
Unité Onco- Hématologie Pédiatrique CHU Estaing 1 place Lucie-Aubrac	Clermont-Ferrand	France	Not Yet Recruiting
Service Immuno-Hématologie Oncologie Pédiatrique	Dijon	France	Not Yet Recruiting
Service onco hématologie pédiatrique CHU de Grenoble site Nord - Hôpital Couple enfant	Grenoble	France	Not Yet Recruiting
Unité d'hématologie pédiatrique CHRU de Lille - Hôpital Jeanne de Flandre	Lille	France	Not Yet Recruiting
Service d'Hématologie - Oncologie pédiatrique CHU Limoges - Hôpital de la mère et de l'enfant	Limoges	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	France	Not Yet Recruiting
Service de Pédiatrie et hématologie pédiatrique, CHU de Marseille - Hôpital de la Timone	Marseille	France	Not Yet Recruiting
UAM Hématologie et Oncologie Pédiatrique, CHU de Montpellier - Hôpital Arnaud de Villeneuve	Montpellier	France	Not Yet Recruiting
Service d'hématologie et oncologie pédiatriques, Hôpital enfant-adolescent, CHU NANTES	Nantes	France	Not Yet Recruiting

+ 188 more sites — see the full list on the official registry below.

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