International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorUniversity Hospital Muenster

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

683 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Sponsors and collaborators

University Hospital Muenster

Lead sponsor

Deutsche Krebshilfe e.V., Bonn (Germany)

Collaborator