Overview

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.

Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Everolimus
Gemcitabine
Sirolimus
Vinblastine
Vinorelbine
Criteria
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