International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

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

Interventions

DRUG

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)

DRUG

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)

DRUG

Dexamethasone

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

DRUG

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)

DRUG

Doxorubicin

Part of standard chemotherapy

DRUG

Ifosfamide

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

DRUG

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)

DRUG

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)

DRUG

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)

DRUG

Prednisone

Part of standard chemotherapy

DRUG

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

DRUG

Thioguanine

Part of standard chemotherapy

DRUG

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)

DRUG

Vindesine

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

Sponsors & Collaborators

• Deutsche Krebshilfe e.V., Bonn (Germany)

  collaborator OTHER

• University Hospital Muenster

  lead OTHER

Principal Investigators

• Birgit Burkhardt, Prof. Dr. Dr. · University Hospital Muenster, Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-23

Primary Completion

2030-04-22

Completion

2030-04-22

Countries

• Austria
• Belgium
• China
• Czechia
• Denmark
• Finland
• France
• Germany
• Hungary
• Ireland
• Israel
• Italy
• Netherlands
• Norway
• Poland
• Portugal
• Russia
• Slovakia
• Spain
• Sweden
• Switzerland

Study Locations