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Taking people in DenmarkPhase 3

Vinblastine alone for children and teens with a lymphoma

Tests vinblastine alone in young people with a standard risk lymphoma.

Key facts

Who runs it
GPOH gGmbH
Where
Aalborg, Aarhus N, Copenhagen Oe, and Odense C, DenmarkSee the 4 sitesAlso in 7 other countries, 102 sites
Registry title
International study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine
Status
Recruiting
Phase
Phase 3
People taking part
137 people, planned
Started
5 Feb 2020
Expected to end
6 Jan 2028
Type of study
Interventional
Record updated
21 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Stratification into the standard risk group (SR) by screening: Newly diagnosed ALK-positive ALCL, Stage I not completely resected, or stage II or stage III, MDD negative
  • Age < 18 years
  • Informed consent of the parents/legal guardians (and assent of the competent child) for study participation and data collection, storage and handling given before study entry
  • Participation in national / study group's reference pathology
  • Follow-up for at least 3 years after enrolment is expected
  • Application of a highly effective contraceptive method (Pearl index <1) in sexually active patients
  • Application of one intrathecal triple therapy with Methotrexate, Cytarabine and Prednisolone (or Hydrocortisone respectively) before start of the protocol treatment

Who cannot take part

  • Steroids for more than 2 days or chemotherapy pre-treatment before taking the screening sample for MDD
  • Chemotherapy pre-treatment before start of the study treatment except for: the obligatory initial intrathecal triple therapy with Methotrexate, Cytarabine and Prednisolone (or Hydrocortisone respectively), a possible clinically indicated pre-phase including up to 5 days of steroids combined with up to 3 doses of Vinblastine (and up to 2 doses of Cyclophosphamide)
  • Contraindications for the treatment with Vinblastine: hypersensitivity against VBL or other vinca-alkaloids, leukopenia, other than in the context of the ALCL, severe uncontrolled infection
  • Progressive disease during a possible clinically indicated pre-phase treatment before inclusion in the study
  • Other medical, psychiatric, familial or social condition prohibiting treatment according to the protocol
  • Pregnancy or lactation period

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • How old is the patient who may join a trial?
  • What type of cancer has the patient been diagnosed with?
  • Is this cancer newly diagnosed, or has it come back or not responded to treatment?
  • Is the patient pregnant or breastfeeding?

Where in Denmark

Also in 7 other countries, 102 sites

  • Aalborg University HospitalAalborg, DenmarkTaking people
  • Aarhus University HospitalAarhus N, DenmarkTaking people
  • RigshospitaletCopenhagen Oe, DenmarkTaking people
  • Odense University HospitalOdense C, DenmarkTaking people

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
International cooperative prospective study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine
Plain-language title
Vinblastine alone for children and teens with a lymphomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Fit questions
Built from 2022-501454-11-00, who can take part
Record updated
21 October 2026
Under construction, not live – International study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine (2022-501454-11-00) – Frontlight Research