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Sponsored by: |
Ascenta Therapeutics |
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Information provided by: | Ascenta Therapeutics |
ClinicalTrials.gov Identifier: | NCT00286780 |
This is an open-label Phase 2 study to evaluate the safety and efficay of AT-101 in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia.
Condition | Intervention | Phase |
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Chronic Lymphocytic Leukemia |
Drug: AT-101 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment |
Official Title: | A Phase 2, Open Label Study of AT-101 in Combination With Rituximab in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia |
Enrollment: | 19 |
Study Start Date: | January 2006 |
Study Completion Date: | November 2007 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: AT-101
80 mg of AT-101 once daily for three days every other week, 375 mg/m2 of rituximab weekly for up to 12 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCSD Moores Cancer Center | |
San Diego, California, United States, 92093 |
Principal Investigator: | Thomas Kipps, MD, PhD | UCSD Moores Cancer Center |
Responsible Party: | Ascenta Therapeutics ( Brian Wood, Associate Director, Clinical Development ) |
Study ID Numbers: | AT-101-CS-008 |
Study First Received: | February 3, 2006 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00286780 History of Changes |
Health Authority: | United States: Food and Drug Administration |
AT101 AT-101 cancer |
lymphoctic lukemia Rituximab |
Leukemia, Lymphoid Immunoproliferative Disorders Immunologic Factors Contraceptive Agents Rituximab Contraceptive Agents, Female Contraceptive Agents, Male Gossypol acetic acid Gossypol Leukemia |
Lymphatic Diseases Chronic Lymphocytic Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Retinol acetate Antirheumatic Agents Leukemia, B-Cell Lymphoproliferative Disorders Leukemia, B-cell, Chronic Antineoplastic Agents, Phytogenic |
Leukemia, Lymphoid Immunologic Factors Contraceptive Agents Antineoplastic Agents Physiological Effects of Drugs Contraceptive Agents, Female Reproductive Control Agents Contraceptive Agents, Male Gossypol Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Antispermatogenic Agents |
Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Rituximab Gossypol acetic acid Pharmacologic Actions Lymphatic Diseases Neoplasms Antirheumatic Agents Lymphoproliferative Disorders Leukemia, B-Cell Antineoplastic Agents, Phytogenic Spermatocidal Agents |