Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of Alabama at Birmingham |
---|---|
Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00704691 |
The purpose of this study is to:
There are reports suggesting a therapeutic benefit of thalidomide in patients with refractory and/or relapsed NHL's which have led to the formal investigation of lenalidomide in the treatment of relapsed NHL's.
Condition | Intervention |
---|---|
Peripheral T-Cell Lymphomas Adult T-Cell Leukemia Adult T-Cell Lymphoma Peripheral T-Cell Lymphoma Unspecified Angioimmunoblastic T-Cell Lymphoma Anaplastic Large Cell Lymphoma T/Null Cell Systemic Type Cutaneous t-Cell Lymphoma With Nodal/Visceral Disease |
Drug: Lenalidomide |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open-Label, One Arm Pilot Investigation of Lenalidomide Therapy for Patients With Relapsed and/or Refractory, Peripheral T-Cell Lymphomas |
Estimated Enrollment: | 40 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Lenalidomide
Lenalidomide 25 mg as a daily oral dose days 1-21 followed by a 7 day rest period (28 day cycle) for 1-6 cycles
|
Peripheral T-cell lymphomas (PTCL's) represent a subgroup of Non-Hodgkin's lymphomas with poor prognostic features. Compared to aggressive B-cell lymphomas, PTCL's often present with more advanced disease and sustain less durable remissions following treatment with chemotherapy. With standard anthracycline-based regimens such as CHOP, PTCLs achieve inferior 5-year overall survival rates of around 40% compared to aggressive B-cell lymphomas whose 5-year overall survival rates reach 50-60%. While several salvage regimens have been established for B-cell lymphomas with moderate success, the guidelines for patients with relapsed and/or refractory PTCL's are less clear. Several reports suggest that the immunomodulatory drugs (IMiDs®) have clinical activity in this setting. The aim of this phase 2 study is to evaluate the activity of lenalidomide in relapsed and/or refractory PTCL's.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory test results within these ranges:
Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to therapy and again within 24 hours of prescribing lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex* condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix 1: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
* For patients who have latex allergies or whose partner(s) have latex allergies alternatives will be discussed.
Exclusion Criteria:
Contact: Alma DelGrosso, RN, BSN, OCN | (205) 934-0337 | Alma.DelGrosso@ccc.uab.edu |
United States, Alabama | |
University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 - 0104 | |
Principal Investigator: James Foran, M.D. |
Principal Investigator: | James Foran, M.D. | University of Alabama at Birmingham |
Responsible Party: | University of Alabama at Birmingham ( James Foran, M.D. ) |
Study ID Numbers: | F071108004, UAB 0663 |
Study First Received: | June 21, 2008 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00704691 |
Health Authority: | United States: Institutional Review Board |
Leukemia, Lymphoid Sezary syndrome Cutaneous T-cell lymphoma Sezary Syndrome Mycosis Fungoides Lymphoma, T-Cell, Peripheral Lymphoma, B-Cell Lymphoma, large-cell Mycoses Leukemia Lymphoma, T-Cell Lymphoma, Large-Cell, Anaplastic Lymphoma |
Peripheral T-cell lymphoma Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Leukemia-Lymphoma, Adult T-Cell Immunoblastic Lymphadenopathy Lenalidomide Lymphatic Diseases B-cell lymphomas Leukemia, T-Cell Anaplastic large cell lymphoma Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |