ALCL-VBL: International clinical study for children and adolescents with ALK-positive anaplastic large cell lymphoma of standard risk
Résumé de l'étude
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 étudiée
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)
Maladie en cours d'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)
Critères d'exclusion
• Pregnancy or breastfeeding • Contraindication for treatment with vinblastine • Chemotherapy already performed before the start of the study (with some exceptions) (BASEC)
Lieu de l’étude
Aarau, Bâle, Bellinzona, Berne, Genève, Lausanne, Luzern, St-Gall, Zurich
(BASEC)
Sponsor
German Pediatric Oncology Group GPOH gGmbH Swiss Paediatric Oncology Group (SPOG)
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
PD Dr. med. Francesco Ceppi
+41 21 314 34 89
francesco.ceppi@clutterchuv.chCHUV - Centre hospitalier universitaire vaudois
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
12.12.2023
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
International cooperative prospective study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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