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 |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | December 2009 |
End Date: | November 2014 |
An Open-label, Single-arm Phase II Study of RAD001 in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
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.
has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after
gemcitabine- or vinorelbine- or vinblastine-based treatment.
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
We found this trial at
16
sites
St. Louis, Missouri 63110
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1400 South Orange Avenue
Orlando, Florida 32806
Orlando, Florida 32806
(407) 648-3800
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
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Atlanta, Georgia 30322
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Madison, Wisconsin 53792
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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