OncoMatch

OncoMatch/Clinical Trials/NCT04043494

International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

Is NCT04043494 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments for lymphoblastic lymphoma, childhood.

Phase 3RecruitingUniversity Hospital MuensterNCT04043494Data as of Jun 2026Location: International · 21 countries

Treatment: Cyclophosphamide · Cytarabine · Dexamethasone · Daunorubicin · Doxorubicin · Ifosfamide · 6-Mercaptopurine · Methotrexate · PEG asparaginase · Prednisone · Prednisolone · Thioguanine · Vincristine · VindesinePrimary 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)

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Extracted eligibility criteria

Treatments studied

Chemotherapy

CyclophosphamideCytarabineDaunorubicinDoxorubicinIfosfamideMethotrexateThioguanineVincristineVindesine

Other

Dexamethasone6-MercaptopurinePEG asparaginasePrednisonePrednisolone

Cancer type

Acute Lymphoblastic Leukemia

Non-Hodgkin Lymphoma

Demographics

Ages ≤ 18

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: steroid

Exception: pre-treatment with ≥ 1 mg/kg/d for more than two weeks during the last month before diagnosis

steroid pre-treatment with ≥ 1 mg/kg/d for more than two weeks during the last month before diagnosis

Cannot have received: cytostatic drugs

pre-treatment with cytostatic drugs

Lab requirements

Kidney function

severe renal impairment (creatinine clearance less than 20 ml/min) [excluded]

Liver function

severe hepatic impairment (bilirubin >3 times ULN, transaminases >10 times ULN) [excluded]

Cardiac function

myocardial insufficiency, severe arrhythmias [excluded]

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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT04043494 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 18 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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