A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell CLL Following Second Line Therapy (THE CONTINUUM TRIAL) - NCT00774345-07601 (Clinical Trial 247962)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy247962.aspx
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| City: |
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Hackensack |
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State:
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NJ |
| Zip Code: |
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07601 |
| Conditions: |
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B-cell Chronic Lymphocytic Leukemia |
| Purpose: |
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The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective
as a maintenance therapy at improving further the quality of the response you achieved with
your last therapy and at prolonging the duration of your response. This study will compare
the effects (good and bad) of lenalidomide with the dummy drug.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
1. Must sign an informed consent form.
2. Age ≥ 18 years
3. Must be able to adhere to the study visit schedule and other protocol requirements.
4. Must have a documented diagnosis of B-cell CLL.
5. Must have been treated with a purine analog-containing regimen in the first and/or
second line induction therapy.
6. Must have achieved a minimum of partial response following completion of second-line
induction therapy.
7. Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of
≤2.
8. Must agree to follow pregnancy precautions as required by the protocol.
9. Must agree to receive counseling related to teratogenic and other risks of
lenalidomide.
10. Must agree not to donate blood, eggs or sperm as defined by the protocol
Exclusion Criteria:
1. Any medical condition, that would prevent the subject from signing the informed
consent form.
2. Active infections requiring systemic antibiotics.
3. Systemic infection that has not resolved > 2 months prior to initiating lenalidomide
4. Autologous or allogeneic bone marrow transplant as second line therapy.
5. Pregnant or lactating females.
6. Participation in any clinical study or having taken any investigational therapy
within 28 days.
7. Known presence of alcohol and/or drug abuse.
8. Central nervous system (CNS) involvement.
9. Prior history of malignancies, other than CLL, unless the subject has been free of
the disease for ≥3 years. Exceptions include the following:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
10. History of renal failure requiring dialysis.
11. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C
Virus (HCV) infection.
12. Prior therapy with lenalidomide.
13. Presence of specific hematology and/or chemistry abnormalities
14. Severe rash due to prior thalidomide treatment
15. Uncontrolled hyperthyroidism or hypothyroidism
16. Venous thromboembolism within one year
17. ≥ Grade-2 neuropathy
18. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia |
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| Study is available at: |
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Hackensack University Medical Center
Hackensack, NJ 07601
United States
Primary Contact:
Jimmy Nieves
Email: jimmynieves@humed.com
Phone: 201-336-8230
Secondary Contact:
Marcia Rios, MBA
Email: marios@celgene.com
Phone: 908-673-9267 |
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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 16, 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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