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Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.
This is a multi-center, open-label, Phase I study of Obatoclax administered in combination with bortezomib in 3-week cycles to patients with relapsed or refractory Mantle Cell Lymphoma. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described herein may be administered with the intent to treat the patients's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Mantle Cell Lymphoma are allowed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 30mg obatoclax, 1.0mg/m2 bortezomib |
|
| 2 | Experimental | obatoclax 30 mg, bortezomib 1.3 mg/m2 |
|
| 3 | Experimental | Obatoclax 45 mg, Bortezomib 1.3 mg/m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obatoclax mesylate | Drug | 30 mg, 45 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile | 4 weeks to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusion and growth factor requirements | 4 weeks to 2 years |
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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 |
|---|---|---|---|---|---|---|
| NW Georgia Oncology Centers | Marietta | Georgia | 30060 | United States | ||
| Northwestern University Feinberg School of Medicine |
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| Bortezomib | Drug | 1.0mg/m2, 1.3 mg/m2 |
|
| Chicago |
| Illinois |
| 60611 |
| United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Roswell Park Medical Center | Buffalo | New York | 14263 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C520962 | obatoclax |
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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