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

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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.


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
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Madison, WI
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1400 South Orange Avenue
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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Orlando, FL
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Atlanta, GA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Chicago, IL
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Detroit, Michigan 48201
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Detroit, MI
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Durham, NC
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Greenwood Village, Colorado
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Houston, TX
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Los Angeles, CA
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Memphis, TN
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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New York, NY
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Rochester, Minnesota 55905
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Rochester, MN
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St. Louis, MO
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