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This protocol is being run to determine the best phase II dose and schedule of obatoclax in patients with previously untreated CLL.
Both 1 hour and 3 hour infusions of obatoclax every 3 weeks will be evaluated in ascending doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GX15-070MS | Experimental | GX15-070MS at various doses and schedules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GX15-070MS | Drug | A 60-minute or 3-hour IV infusion every 2-3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the response rate of previously-treated patients with CLL at the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Viallet, MD | Gemin X, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of CA- San Diego | La Jolla | California | 92093 | United States | ||
| Lombardi Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18931344 | Result | O'Brien SM, Claxton DF, Crump M, Faderl S, Kipps T, Keating MJ, Viallet J, Cheson BD. Phase I study of obatoclax mesylate (GX15-070), a small molecule pan-Bcl-2 family antagonist, in patients with advanced chronic lymphocytic leukemia. Blood. 2009 Jan 8;113(2):299-305. doi: 10.1182/blood-2008-02-137943. Epub 2008 Oct 17. |
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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 |
|---|---|
| C520962 | obatoclax |
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| GX15-070MS | Drug | GX15-070MS at various doses and schedules |
|
|
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Milton S Hershey Medical Center Penn State Cancer Institute | Hershey | Pennsylvania | 17033 | United States |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| 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 |