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| Sponsor: | Biogen Idec |
|---|---|
| Information provided by: | Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00319930 |
Purpose
The purpose of the study is to evaluate the effects of increasing doses of CNF1010 on pharmacodynamic markers and hematological response.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia |
Drug: CNF1010 (17-AAG) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Pharmacodynamic Study of Intravenously Administered CNF1010 (17-(Allylamino)-17-demethoxy-geldanamycin [17-AAG]) in Patients With ZAP-70 Positive B-Cell Chronic Lymphocytic Leukemia (CLL) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Diagnosis of B-cell CLL including
Intermediate or High risk, poor prognosis CLL refractory to fludarabine-based therapy as defined by one of the following:
OR
· CLL patients intolerant to fludarabine-based therapy. [Intolerance is defined as the development of any serious medical condition occurring after exposure to fludarabine that would restrict further use of the agent as treatment for the patient's CLL (i.e., autoimmune hemolytic anemia, myelosuppression, hypersensitivity)]
Laboratory parameters as follows:
Key Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| Ocoee, Florida, United States, 34761 | |
| United States, New York | |
| Albany, New York, United States, 12208 | |
| United States, Ohio | |
| Dayton, Ohio, United States, 45409 | |
| United States, South Carolina | |
| Greenville, South Carolina, United States, 29605 | |
| United States, Texas | |
| Tyler, Texas, United States, 75702 | |
| United States, Virginia | |
| Norfolk, Virginia, United States, 85258 | |
More Information
| Responsible Party: | Study MD, Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00319930 History of Changes |
| Other Study ID Numbers: | CNF1010-CLL-05001, 110CL101 |
| Study First Received: | April 27, 2006 |
| Last Updated: | March 4, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Chronic lymphocytic leukemia CLL ZAP-70 Hsp90 inhibitor |
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms |
Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |