ALCL-VBL: International clinical study for children and adolescents with ALK-positive anaplastic large cell lymphoma of standard risk
Summary description of the study
ALK-positive anaplastic large cell lymphoma (ALCL) is part of the non-Hodgkin lymphomas, which are cancerous conditions of the lymph nodes. ALCL is the third most common subgroup in this regard. Without treatment, lymphoma cells spread rapidly throughout the body, hence the need for treatment. This consists of a chemotherapeutic combination administered over several hospitalizations over a period of 5 to 6 months. ALCL-VBL is an international therapeutic optimization study examining ALK-positive anaplastic large cell lymphomas in children and adolescents. Its main objective is to ensure, with vinblastine, that patients in the standard risk group can benefit from a treatment that is at least as effective as the current standard treatment while significantly limiting side effects and risks of long-term effects.
(BASEC)
Intervention under investigation
The drug vinblastine is administered directly into a blood vessel once a week for the first 18 months, then every two weeks during the last six months. The treatment thus lasts a total of 24 months. Treatment with vinblastine can be done on an outpatient basis, meaning that hospitalization is only necessary in case of complications. During outpatient treatment, it is generally possible to attend school, continue training, studies, or professional activities.
Regular examinations are conducted during treatment, such as imaging tests, blood analyses, and clinical examinations. A follow-up will be conducted at the end of treatment.
(BASEC)
Disease under investigation
ALK-positive anaplastic large cell lymphoma
(BASEC)
• Patients under 18 years of age • Newly diagnosed with standard risk ALK-positive anaplastic large cell lymphoma • Written consent declaration for participation in the study (BASEC)
Exclusion criteria
• Pregnancy or breastfeeding • Contraindication for treatment with vinblastine • Chemotherapy already performed before the start of the study (with some exceptions) (BASEC)
Trial sites
Aarau, Basel, Bellinzona, Bern, Geneva, Lausanne, Luzern, St. Gallen, Zurich
(BASEC)
Sponsor
German Pediatric Oncology Group GPOH gGmbH Swiss Paediatric Oncology Group (SPOG)
(BASEC)
Contact
Contact Person Switzerland
PD Dr. med. Francesco Ceppi
+41 21 314 34 89
francesco.ceppi@clutterchuv.chCHUV - Centre hospitalier universitaire vaudois
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
12.12.2023
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
International cooperative prospective study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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