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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002935-40-DE

Enrollment

106

Registered

2020-01-16

Start date

2020-08-17

Completion date

Unknown

Last updated

2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

standard risk ALK-positive anaplastic large cell lymphoma (ALCL)

Interventions

Trade Name: Velbe, different generics Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: VINBLASTINE CAS Number: 865-21-4 Concentration unit: mg/m2 milligram(s)/square meter Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Stratification into the standard risk group (SR) by screening: o Newly diagnosed ALK-positive ALCL o Stage I not completely resected, or stage II or stage III o MDD negative • Age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Progressive disease during a possible clinically indicated pre-phase treatment before inclusion in the study • 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 o the obligatory initial intrathecal triple therapy with Methotrexate, Cytarabine and Prednisolone (or Hydrocortisone respectively) o 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) • Pregnancy or lactation period • Contraindications for the treatment with Vinblastine: o hypersensitivity against VBL or other vinca-alkaloids o leukopenia, other than in the context of the ALCL o severe uncontrolled infection • Other medical, psychiatric, familial or social condition prohibiting treatment according to the protocol

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Secondary objectives and endpoints of the study are •To describe overall survival and treatment related mortality of 24 months Vinblastine monotherapy. Overall survival is the time from diagnosis to death of any cause or last follow-up. •To identify clinical, pathological and biological factors predictive of progressive disease during / after VBL therapy. The time of progressive disease is the time from diagnosis to progressive disease or a competing event (death from any cause, secondary malignancy) or last follow-up. •To estimate the rate of SR patients requiring multi-agent chemotherapy •To describe the toxicity of Vinblastine given for 24 months rated with CTCAE v4.03. •To describe the response after 3 weeks (on day 17-22), 3 months and 6 months of treatment (including a possible pre-phase) assessed by appropriate imaging methods ;Primary end point(s): Endpoint is the probability of event-free-survival (pEFS) at 3 years, with event-free-survival (EFS) defined as the time of diagnosis to the first event (progressive disease, nonresponse, secondary malignancy or death due to any cause) or last follow-up. ;Timepoint(s) of evaluation of this end point: 3 years post treatment;Main Objective: The primary objective of the study is to show that it is possible to cure at least 75% of patients belonging to the SR group with Vinblastine monotherapy for 24 months. Endpoint is the probability of event-free-survival (pEFS) at 3 years, with event-free-survival (EFS) defined as the time of diagnosis to the first event (progressive disease, nonresponse, secondary malignancy or death due to any cause) or last follow-up.	—

Measure

Time frame

Secondary Objective: Secondary objectives and endpoints of the study are •To describe overall survival and treatment related mortality of 24 months Vinblastine monotherapy. Overall survival is the time from diagnosis to death of any cause or last follow-up. •To identify clinical, pathological and biological factors predictive of progressive disease during / after VBL therapy. The time of progressive disease is the time from diagnosis to progressive disease or a competing event (death from any cause, secondary malignancy) or last follow-up. •To estimate the rate of SR patients requiring multi-agent chemotherapy •To describe the toxicity of Vinblastine given for 24 months rated with CTCAE v4.03. •To describe the response after 3 weeks (on day 17-22), 3 months and 6 months of treatment (including a possible pre-phase) assessed by appropriate imaging methods ;Primary end point(s): Endpoint is the probability of event-free-survival (pEFS) at 3 years, with event-free-survival (EFS) defined as the time of diagnosis to the first event (progressive disease, nonresponse, secondary malignancy or death due to any cause) or last follow-up. ;Timepoint(s) of evaluation of this end point: 3 years post treatment;Main Objective: The primary objective of the study is to show that it is possible to cure at least 75% of patients belonging to the SR group with Vinblastine monotherapy for 24 months. Endpoint is the probability of event-free-survival (pEFS) at 3 years, with event-free-survival (EFS) defined as the time of diagnosis to the first event (progressive disease, nonresponse, secondary malignancy or death due to any cause) or last follow-up.

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary objectives and endpoints of the study are •To describe overall survival and treatment related mortality of 24 months Vinblastine monotherapy. Overall survival is the time from diagnosis to death of any cause or last follow-up. •To identify clinical, pathological and biological factors predictive of progressive disease during / after VBL therapy. The time of progressive disease is the time from diagnosis to progressive disease or a competing event (death from any cause, secondary malignancy) or last follow-up. •To estimate the rate of SR patients requiring multi-agent chemotherapy •To describe the toxicity of Vinblastine given for 24 months rated with CTCAE v4.03. •To describe the response after 3 weeks (on day 17-22), 3 months and 6 months of treatment (including a possible pre-phase) assessed by appropriate imaging methods;Timepoint(s) of evaluation of this end point: 3 years post treatment or last follow up visit	—

Measure

Time frame

Secondary end point(s): Secondary objectives and endpoints of the study are •To describe overall survival and treatment related mortality of 24 months Vinblastine monotherapy. Overall survival is the time from diagnosis to death of any cause or last follow-up. •To identify clinical, pathological and biological factors predictive of progressive disease during / after VBL therapy. The time of progressive disease is the time from diagnosis to progressive disease or a competing event (death from any cause, secondary malignancy) or last follow-up. •To estimate the rate of SR patients requiring multi-agent chemotherapy •To describe the toxicity of Vinblastine given for 24 months rated with CTCAE v4.03. •To describe the response after 3 weeks (on day 17-22), 3 months and 6 months of treatment (including a possible pre-phase) assessed by appropriate imaging methods;Timepoint(s) of evaluation of this end point: 3 years post treatment or last follow up visit

—

Countries

Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Iceland, Japan, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom

Contacts

Public ContactKatharina Röllecke

Pädiatrisches Forschungsnetzwerk gGmbH

k.roellecke@forschung-paediatrie.de0049020174949613

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026