ALCL-VBL: International clinical study for children and adolescents with ALK-positive anaplastic large cell lymphoma of standard risk
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
• Pregnancy or breastfeeding • Contraindication for treatment with vinblastine • Chemotherapy already performed before the start of the study (with some exceptions) (BASEC)
Luogo dello studio
Aarau, Basilea, Bellinzona, Berna, Ginevra, Losanna, Luzern, San Gallo, Zurigo
(BASEC)
Sponsor
German Pediatric Oncology Group GPOH gGmbH Swiss Paediatric Oncology Group (SPOG)
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
PD Dr. med. Francesco Ceppi
+41 21 314 34 89
francesco.ceppi@clutterchuv.chCHUV - Centre hospitalier universitaire vaudois
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Vaud
(BASEC)
Data di approvazione del comitato etico
12.12.2023
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
International cooperative prospective study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine (BASEC)
Titolo accademico
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Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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