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Sponsors and Collaborators: |
Scripps Health Bristol-Myers Squibb Celgene Corporation |
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Information provided by: | Scripps Health |
ClinicalTrials.gov Identifier: | NCT00829647 |
Dasatinib and lenalidomide are both prescribed for use in patients with different cancers of the blood. This study is experimental because neither drug has been approved by the Food and Drug Administration for the treatment of chronic lymphocytic leukemia. There are few standard treatments when fludarabine is no longer effective in patients with CLL. Some patients have received additional combination therapy with fludarabine, Campath, bone marrow transplants or supportive care. Dasatinib and lenalidomide have been effective in high-risk CLL patients in other pilot mono therapy studies. The combination of dasatinib and lenalidomide has not been studied in humans before and this study is designed to test whether this combination is safe to use.
Condition | Intervention | Phase |
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Chronic Lymphocytic Leukemia |
Drug: dasatinib and lenalidomide |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of Combination Dasatinib and Lenalidomide in Purine Analogue-Failed Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 30 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Combination Lenalidomide and Dasatinib: Experimental
Combination lenalidomide and dasatinib
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Drug: dasatinib and lenalidomide
dasatinib will be started at 70mg/day po and lenalidomide will be started at 2.5mg/day po
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CLL is an incurable disease with current therapies. Modern chemoimmunotherapies, including combinations of rituximab and purine nucleoside analogues (fludarabine, cladribine, and pentostatin), offer the possibility for improved survival, but all patients will eventually relapse. Patients with relapsed or refractory disease will only experience diminishing benefits with additional lines of therapy. In addition, patients with high-risk CLL have poor responses to even first-line therapies. Lenalidomide and dasatinib have non-overlapping proposed mechanisms of action. Single agent phase II studies with lenalidomide and dasatinib have demonstrated responses in heavily pretreated and high-risk patients. For these reasons, we propose to treat patients with relapsed and/or refractory CLL to purine nucleoside analogue therapy with combination lenalidomide and dasatinib.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Relapsed and/or refractory disease to a purine nucleoside analogue (pentostatin, fludarabine, or cladribine). Relapse is defined as a patient who has previously achieved the clinicopathologic criteria for a CR or PR, but after a period of ≥ 6 months demonstrates evidence of disease progression.
Refractory is defined as a patient progressing on therapy or who cannot maintain at least a PR for ≥ 6 months (Appendix IV). The patient may have had therapy subsequent to receiving a purine nucleoside analogue, but must also have relapsed or been refractory to this most recent therapy (Appendix IV).
Laboratory test results within these ranges:
Disease free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast. Patients with low- and intermediate-risk prostate cancer who have had either local therapy (radiation or surgery) or are actively receiving hormonal therapy will also be allowed. Patients being observed with "watchful waiting" will be excluded.
Low- and intermediate-risk prostate cancer will be defined as PSA ≤ 20, Gleason score ≤ 7, and AJCC clinical stage of ≤ T2b.
Concomitant Medications
Exclusion Criteria:
Women who:
Concomitant Medications, any of the following should be considered for exclusion:
History of significant bleeding disorder unrelated to cancer, including:
Cardiac Symptoms; any of the following should be considered for exclusion:
Concurrent medical condition which may increase the risk of toxicity, including:
Contact: Darren Sigal, MD | 858-554-5269 | Sigal.darren@scrippshealth.org |
Contact: Amy Nancy, RN | 858-554-8533 | nance.amy@scrippshealth.org |
United States, California | |
Scripps Cancer Center | Recruiting |
La Jolla, California, United States, 92037 | |
Contact: Debbie Desino, RN 858-652-5465 Desino.Debbie@scrippshealth.org | |
Contact: Cheryl Blair-Hurst 858-652-5543 | |
Principal Investigator: Darren Sigal, MD | |
Sub-Investigator: Alan Saven, MD |
Principal Investigator: | Darren Sigal, MD | Staff Scripps Cancer Center |
Responsible Party: | Scripps Clinic Medical Group/ScrippsHealth ( Darren Sigal MD ) |
Study ID Numbers: | SCLL084993 |
Study First Received: | January 23, 2009 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00829647 History of Changes |
Health Authority: | United States: Food and Drug Administration |
CLL dasatinib lenalidomide |
sprycel revlimid CLL relapsed or refractory to fludarabine |
Leukemia, Lymphoid Immunoproliferative Disorders Lenalidomide Fludarabine monophosphate Protein Kinase Inhibitors Leukemia Lymphatic Diseases |
Chronic Lymphocytic Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Dasatinib Fludarabine Leukemia, B-Cell Lymphoproliferative Disorders Leukemia, B-cell, Chronic |
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Lenalidomide Enzyme Inhibitors Protein Kinase Inhibitors |
Pharmacologic Actions Leukemia Lymphatic Diseases Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Dasatinib Leukemia, B-Cell Lymphoproliferative Disorders |