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| Sponsor: | Ascenta Therapeutics |
|---|---|
| Information provided by: | Ascenta Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00440388 |
Purpose
This is a phase II clinical trial in patients who have not received systemic treatment for follicular non-Hodgkin's lymphoma. The study combines rituximab, an approved drug for this disease, with AT-101, an experimental drug. The hypothesis is that by adding AT-101 to the rituximab regimen, improvement to patients' response to the treatment will be observed verses rituximab alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Follicular Lymphoma |
Drug: AT-101 Drug: Rituximab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | An Open-Label, Multicenter, Phase II Study of AT-101 in Combination With Rituximab in Patients With Untreated, Grade I-II, Follicular Non-Hodgkin's Lymphoma |
| Estimated Enrollment: | 52 |
| Study Start Date: | October 2006 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Further Study Details provided by Ascenta.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate hematological function as indicated by:
Adequate hepatic and renal function as indicated by:
Exclusion Criteria:
Contacts and Locations
Show 28 Study Locations| Study Director: | Lance Leopold, MD | Ascenta Therapeutics, Inc. |
More Information
| Responsible Party: | Ascenta Therapeutics ( Jeffrey Brill, Associate Director, Clinical Development ) |
| Study ID Numbers: | AT-101-CS-203 |
| Study First Received: | February 23, 2007 |
| Last Updated: | December 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00440388 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
cancer lymphoma Non-Hodgkin's Non-Hodgkins |
AT-101 AT101 Rituxan Rituximab |
|
Immunologic Factors Contraceptive Agents Antineoplastic Agents Physiological Effects of Drugs Lymphoma, Follicular Contraceptive Agents, Female Reproductive Control Agents Contraceptive Agents, Male Gossypol Therapeutic Uses Antispermatogenic Agents Lymphoma Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Rituximab Gossypol acetic acid Pharmacologic Actions Lymphatic Diseases Neoplasms Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Antirheumatic Agents Antineoplastic Agents, Phytogenic Spermatocidal Agents |