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autologous human tumor-derived…

A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma

Ensayo de AGENUS INC en Linfoma folicular · Linfoma linfocitico pequeno.

Fase

Fase 2

Estado

Completado

Participantes

35

previstos

Centros

1

Fin del objetivo primario

jun 2005

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en mar 2000.

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objectives: * To document the efficacy of treatment with autologous lymphoma-derived HSPPC-96 of selected patients with indolent lymphoma. The efficacy endpoints are: * the rate of complete and partial responses * the time to progression. Secondary Objectives: * To evaluate the safety and tolerability of autologous tumor-derived heat-shock protein peptide complex (HSPPC-96) administered intradermally once weekly for four consecutive weeks, followed by HSPPC-96 administered once every two weeks. * To evaluate the feasibility of autologous HSPPC-96 preparation from lymphoma specimens. * To assess approximately the composition of the tissue source of the autologous HSPPC-96 for each patient. * To study the effect of autologous lymphoma-derived HSPPC-96 vaccine therapy on the expression of Fas ligand and TRAIL death proteins in peripheral blood lymphocytes of patients with indolent lymphoma.

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Ficha completa en ClinicalTrials.gov (NCT00081809), actualizada en sep 2023.