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International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

ConditionLymphoblastic Lymphoma, Childhood
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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)

  • 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)

  • Dexamethasone

    Drug

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

  • 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)

  • Doxorubicin

    Drug

    Part of standard chemotherapy

  • Ifosfamide

    Drug

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

  • 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)

  • 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)

  • 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)

  • Prednisone

    Drug

    Part of standard chemotherapy

  • 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

  • Thioguanine

    Drug

    Part of standard chemotherapy

  • 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)

  • Vindesine

    Drug

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

Treatment groups

683 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: SR I/II: R1 into protocol Ia-PredOther 9 interventions
Group B: SR I/II: R1 into protocol Ia-DexaExperimental treatment 10 interventions
Group C: SR: R1 into protocol Ia-PredOther 12 interventions
Group D: SR: R1 into protocol Ia-DexaExperimental treatment 12 interventions
Group E: HR: R1 into "Pred" and R2 into non-HR extra-compartment phaseOther 12 interventions
Group F: HR: R1 into "Dexa" and R2 into non-HR extra-compartment phaseExperimental treatment 12 interventions
Group G: HR: R1 into "Pred" and R2 into HR extra-compartment phaseExperimental treatment 14 interventions
Group H: HR: R1 into "Dexa" and R2 into HR extra-compartment phaseExperimental treatment 14 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
through study completion, maximal 7.25 years
2

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.

Time frame
through study completion, maximal 7.25 years

Secondary outcomes

1

Survival (pOS)

Survival (pOS) is defined as time from diagnosis to death due to any cause or to the date of last contact for patients alive

Time frame
through study completion, maximal 7.25 years
2

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

Time frame
through study completion, maximal 7.25 years
3

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

Time frame
through study completion, maximal 7.25 years
4

Frequency of adverse events of interest and severe adverse events overall

Time frame
through study completion, maximal 7.25 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Muenster

Lead sponsor

Deutsche Krebshilfe e.V., Bonn (Germany)

Collaborator

Source ClinicalTrials.gov
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