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.
Completed · Phase 2
Conditions studied: Hodgkin Lymphoma
In brief
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.
Key facts
- Study ID
- NCT01022996
- Run by
- Novartis Pharmaceuticals
- People needed
- 57
- Starts
- 2009-12-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2016-05-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of California at Los Angeles UCLS School of Medicine — Los Angeles, California, United States
- Rocky Mountain Cancer Centers RMCC - Aurora — Greenwood Village, Colorado, United States
- MD Anderson Cancer Center - Orlando — Orlando, Florida, United States
- Emory University School of Medicine/Winship Cancer Institute Emory University Med School — Atlanta, Georgia, United States
- Lurie Children's Hospital of Chicago Robert H. Lurie Comp Cancer — Chicago, Illinois, United States
- Indiana University Simon Cancer Center — Indianapolis, Indiana, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Karmanos Cancer Institute Karmanos-1 — Detroit, Michigan, United States
- Mayo Clinic - Rochester Mayo Lymphoma Group — Rochester, Minnesota, United States
- Washington University School Of Medicine-Siteman Cancer Ctr StudyCoordinator:CLBH589B2201 — St Louis, Missouri, United States
- New York Presbyterian Hospital Weill Cornell Med Ctr — New York, New York, United States
- Duke University Medical Center Duke University Medical Ctr — Durham, North Carolina, United States
- University of Tennessee Cancer Institute Univ Tennessee Cancer — Memphis, Tennessee, United States
- University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3) — Houston, Texas, United States
- University of Wisconsin Comprehensive Cancer Center Clinical Science Center - H4 — Madison, Wisconsin, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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