A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma - NCT00655668-67214 (Clinical Trial 213357)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy213357.aspx
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| City: |
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Wichita |
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State:
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KS |
| Zip Code: |
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67214 |
| Conditions: |
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Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma |
| Purpose: |
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This is a Phase II, multicenter, single-arm, open-label study of oral lenalidomide
monotherapy administered to subjects with relapsed or refractory T-cell lymphoma. This
study will be conducted in two phases: a Treatment Phase and a Follow-up Phase.
Subjects who qualify for enrollment into the study will enter the Treatment Phase and
receive single-agent lenalidomide 25 mg once daily on Days 1-21 every 28 days (28-day
cycles). Subjects may continue participation in the Treatment Phase of the study for a
maximum duration of 24 months, or until disease progression or unacceptable AEs develop.
All subjects who discontinue the Treatment Phase for any reason will continue to be followed
until progression of disease or until next lymphoma treatment is given, whichever comes
first, during the Follow-up Phase.
Objectives:
Primary:
• To determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell
NHL. Efficacy will be assessed by measuring the response rate, tumor control rate, duration
of response, time to progression and progression free survival.
Secondary:
• To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed
or refractory T-cell NHL.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Must understand and voluntarily sign an informed consent form.
- Must be ≥ 18 years of age at the time of signing the informed consent form.
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Biopsy-proven T-cell non-Hodgkin's lymphoma, either:
- PTCL whatever the subtype, or
- CTCL, but only the subtype mycosis fungoides.
- Relapsed or refractory to previous therapy for T-cell NHL.
- Must have received at least one prior combination chemotherapy regimen. There is no
limit on the number of prior therapies.
Exclusion Criteria:
- CTCL of subtype Sézary syndrome. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 4, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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