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To determine what side effects and what clinical effects if any the administration of this investigational product, IDEC-152 (an antibody against CD23 which is an important protein on leukemia cells and certain cells in the body's immune system), has on the CLL patient population.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDEC-152 | Drug | 6 Dosing groups: 125mg/m2 weekly x 4, 250mg/m2 weekly x 4, 375mg/m2 weekly x 4, 500mg/m2 weekly x 4, 500mg/m2 3 times first week then weekly x 3, 500mg/m2 3 times per week x 4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL | 48 months | |
| Characterize the safety profile of IDEC-152 | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the pharmacokinetics and pharmacodynamics of IDEC-152 in patients with relapsed or refractory CLL | 48 months | |
| Evaluate the efficacy of IDEC-152 in patients with relapsed or refractory CLL | 48 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | La Jolla | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17671129 | Background | Byrd JC, O'Brien S, Flinn IW, Kipps TJ, Weiss M, Rai K, Lin TS, Woodworth J, Wynne D, Reid J, Molina A, Leigh B, Harris S. Phase 1 study of lumiliximab with detailed pharmacokinetic and pharmacodynamic measurements in patients with relapsed or refractory chronic lymphocytic leukemia. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4448-55. doi: 10.1158/1078-0432.CCR-06-1463. | |
| 18032710 |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C509683 | lumiliximab |
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| Baltimore |
| Maryland |
| United States |
| Research Site | New Hyde Park | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Columbus | Ohio | United States |
| Research Site | Houston | Texas | United States |
| Background |
| Pathan NI, Chu P, Hariharan K, Cheney C, Molina A, Byrd J. Mediation of apoptosis by and antitumor activity of lumiliximab in chronic lymphocytic leukemia cells and CD23+ lymphoma cell lines. Blood. 2008 Feb 1;111(3):1594-602. doi: 10.1182/blood-2007-03-082024. Epub 2007 Nov 21. |
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |