|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 23 |
| 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: | Jeffrey Brill, Associate Director, Clinical Development, Ascenta Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00440388 History of Changes |
| Other Study ID Numbers: | AT-101-CS-203 |
| Study First Received: | February 23, 2007 |
| Last Updated: | August 24, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
cancer lymphoma Non-Hodgkin's Non-Hodgkins |
AT-101 AT101 Rituxan Rituximab |
|
Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Gossypol Gossypol acetic acid Rituximab Contraceptive Agents, Male |
Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antineoplastic Agents, Phytogenic Antineoplastic Agents Contraceptive Agents, Female Spermatocidal Agents Antispermatogenic Agents Immunologic Factors Antirheumatic Agents |