Study of RAD001 in Patients With Relapsed/Refractory Hodgkin Lymphoma That Has Progressed After High-dose Chemotherapy and Autologous Stem Cell Transplant and/or After Gemcitabine- or Vinorelbine- or Vinblastine-based Treatment.

Novartis

Status and phase: Completed; Phase 2

Conditions: Hodgkin Lymphoma

Treatments: Drug: Everolimus (RAD001)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01022996

CRAD001NUS65

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a history of classical Hodgkin's lymphoma that has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after gemcitabine- or vinorelbine- or vinblastine-based treatment
• Patients with at least one site of measurable disease measuring ≥ 2.0cm confirmed by PET and CT Scan (or MRI)
• Patients with adequate bone marrow, liver and renal function (confirmed by laboratory values)
• Patients with fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN

Exclusion criteria

• Previous treatment with mTOR inhibitors
• Prior allogeneic stem cell transplant
• Chemotherapy, monoclonal antibody therapy, major surgery or treatment with other investigational drugs within 4 weeks of starting study treatment
• Another malignancy within 3 years of study entry (except adequately treated non-melanoma skin cancer and carcinoma in situ of the cervix)
• Severe and/or uncontrolled medical conditions that could affect participation in this study
• Female patients who are pregnant or breastfeeding; patients who are not willing to use adequate birth control during the study and for 8 weeks after the last study treatment Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

RAD001

Experimental group

Description:

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.

Treatment:

Drug: Everolimus (RAD001)