Treatment protocol for relapsed anaplastic large cell lymphoma of childhood and adolescence - Relapsed ALCL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003321-57-GB

Enrollment

Registered

2005-11-22

Start date

2005-12-23

Completion date

Unknown

Last updated

2020-07-27

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

Conditions

Anaplastic large cell lymphoma

Interventions

Trade Name: Methotrexate Product Name: Methotrexate Pharmaceutical Form: Injection* INN or Proposed INN: Methotrexate CAS Number: 59-05-2 Trade Name: Cytarabine Product Name: Cytarabine Pharmaceutica

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients meeting the following criteria are eligible to be enrolled in the study: · Progression or relapse of anaplastic large cell lymphoma diagnosed either by histomorphological or cytomorphological characterisation · slides of relapsed lymphoma available for national/international pathological and/or cytomorphology review · age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients listed below are not eligible for the study: · 2nd or subsequent relapse of ALCL · significant pre-treatment for 1st relapse (previous chemotherapy or radiotherapy within two months prior to starting the ALCL-Relapse protocol) · inadequate hepatic, renal and cardiac function · HIV infection or AIDS, severe immunodeficiency · previous organ transplantation · previous malignancy prior to anaplastic large cell lymphoma · pre-existing disease prohibiting chemotherapy as per instructions of the protocol · clinical condition prohibiting the conditioning regimen as per instruction of the protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to test the efficacy of a treatment strategy for relapsed anaplastic large cell lymphoma. Primary objectives of the study are: 1. to improve the probability of event free survival in children and adolescents with early progression of ALCL or a relapse of ALCL with CD3 positive immunophenotype 2. to test whether BEAM conditioning regimen (without TBI) with autologous stem cell transplantation is an effective treatment in patients with CD3 negative ALCL relapsing after the intensive phase of treatment 3. to test the impact of Vinblastine in patients with late relapse of an CD3 negative ALCL who have not received Vinblastine during firstline therapy ;Secondary Objective: Secondary objectives of the study are 1. to test the reproducibility of the newly introduced stratification criteria as outlined above 2. to control protocol adherence measured as the proportion of patients who are treated according to the protocol out of all patients who meet the inclusion criteria of the protocol 3. to monitor acute and late toxicity of the treatment. ;Primary end point(s): The endpoint for the primary objectives is the Event Free Survival (EFS), defined as the minimum time from the date of relapse/progression to a subsequent event (death from any cause, second relapse, progressive disease, secondary malignancy). EFS will be estimated using the Kaplan-Meier method. The end point for the assessment of the reproducibility of the newly introduced stratification criteria is the proportion of patients who are eligible for allogeneic SCT (early progression, or/and CD3 positive immunophenotype). The endpoint of the assessment of “control for protocol adherence” is the proportion of patients who are treated according to the protocol out of the total number ofl patients who meet the inclusion criteria of the protocol. A patient is judged to be treated according to the protocol if he is transplanted according to his risk classification (au	—

Measure

Time frame

Main Objective: The aim of the study is to test the efficacy of a treatment strategy for relapsed anaplastic large cell lymphoma. Primary objectives of the study are: 1. to improve the probability of event free survival in children and adolescents with early progression of ALCL or a relapse of ALCL with CD3 positive immunophenotype 2. to test whether BEAM conditioning regimen (without TBI) with autologous stem cell transplantation is an effective treatment in patients with CD3 negative ALCL relapsing after the intensive phase of treatment 3. to test the impact of Vinblastine in patients with late relapse of an CD3 negative ALCL who have not received Vinblastine during firstline therapy ;Secondary Objective: Secondary objectives of the study are 1. to test the reproducibility of the newly introduced stratification criteria as outlined above 2. to control protocol adherence measured as the proportion of patients who are treated according to the protocol out of all patients who meet the inclusion criteria of the protocol 3. to monitor acute and late toxicity of the treatment. ;Primary end point(s): The endpoint for the primary objectives is the Event Free Survival (EFS), defined as the minimum time from the date of relapse/progression to a subsequent event (death from any cause, second relapse, progressive disease, secondary malignancy). EFS will be estimated using the Kaplan-Meier method. The end point for the assessment of the reproducibility of the newly introduced stratification criteria is the proportion of patients who are eligible for allogeneic SCT (early progression, or/and CD3 positive immunophenotype). The endpoint of the assessment of “control for protocol adherence” is the proportion of patients who are treated according to the protocol out of the total number ofl patients who meet the inclusion criteria of the protocol. A patient is judged to be treated according to the protocol if he is transplanted according to his risk classification (au

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Countries

United Kingdom

Outcome results

None listed

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