Conditions: Hodgkin Lymphoma
Keywords: Hodgkin's Lymphoma Hodgkin Lymphoma Hodgkin's Disease Hodgkin Disease Lymphoma Lymphoproliferative Disorders Neoplasms by Histological type Lymphatic Diseases Hemic and Lymphatic Diseases Recurrent Lymphoma Refractory Lymphoma Relapsed Lymphoma Classical Hodgkin Lymphoma Classical Hodgkin's Disease Nodular sclerosing Hodgkin Lymphoma Mixed-cellularity Hodgkin Lymphoma Lymphocyte-rich Hodgkin Lymphoma Lymphocyte depleted Hodgkin Lymphoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 57
Healthy volunteers: no

Brief summary:
This study will assess RAD001 in patients with refractory or relapsed Hodgkin Lymphoma that has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after gemcitabine- or vinorelbine- or vinblastine-based treatment.

Detailed description:

Arms:
arm 1: Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. All patients were assigned to a daily dose of everolimus 10 mg (two 5-mg tablets), selfadministered orally and continuously from Cycle 1 Day 1 (Visit 2) until progression of disease, unacceptable toxicity, death, or discontinuation from the study for any other reason.

A treatment cycle consisted of 28 days.

Interventions: intervention 1: Everolimus (RAD001)
Intervention descriptions: intervention 1: Everolimus (RAD001) 10 mg (two 5mg tablets) given orally once daily and packed in blisters.

Protocol document: