International study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine

Brief summary (registry, in English)

To show that it is possible to cure at least 75% of patients belonging to the SR group with Vinblastine-monotherapy for 24 months.

What you commit to

• Study type: Interventional · Phase 3
• Planned participants: 137
• 106 sites in 8 countries
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers under 18 with newly diagnosed ALK-positive anaplastic large cell lymphoma (ALCL) in the standard risk group.

Age

Under 18 years

Sex

All sexes

Disease stage

Newly diagnosed ALK-positive ALCL, standard risk group: stage I not completely resected, or stage II or stage III, MDD negative.

Earlier treatment

Before the study, only one intrathecal triple therapy with Methotrexate, Cytarabine and Prednisolone (or Hydrocortisone) is required. Other chemotherapy is not allowed, except a possible short pre-phase of up to 5 days of steroids with up to 3 doses of Vinblastine (and up to 2 doses of Cyclophosphamide).

Biomarker or test result

ALK-positive ALCL, MDD negative.

Main reasons for not taking part

• Disease that got worse during a pre-phase treatment before joining
• Steroids for more than 2 days or chemotherapy before the screening sample for MDD was taken
• Pregnancy or breastfeeding
• Cannot take Vinblastine: allergy to Vinblastine or other vinca-alkaloids, low white blood cells not caused by ALCL, or severe uncontrolled infection
• Other medical, mental health, family or social conditions that prevent treatment according to the protocol

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (106)

Sites in registry order. Save your city in your profile to sort them by distance.

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