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NCT00081809 · ClinicalTrials.gov registry record · Phase 2
A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma
A Phase 2 study, sponsored by Agenus.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT00081809 is a Phase 2 study that has completed, run by Agenus. The registered enrollment target is 35 participants.
The verdict
NCT00081809, a Phase 2 study, has completed, sponsored by Agenus.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
Primary Objectives: * To document the efficacy of treatment with autologous lymphoma-derived HSPPC-96 of selected patients with indolent lymphoma. The efficacy endpoints are: * the rate of complete and partial responses * the time to progression. Secondary Objectives: * To evaluate the safety and tolerability of autologous tumor-derived heat-shock protein peptide complex (HSPPC-96) administered intradermally once weekly for four consecutive weeks, followed by HSPPC-96 administered once every two weeks. * To evaluate the feasibility of autologous HSPPC-96 preparation from lymphoma specimens. * To assess approximately the composition of the tissue source of the autologous HSPPC-96 for each patient. * To study the effect of autologous lymphoma-derived HSPPC-96 vaccine therapy on the expression of Fas ligand and TRAIL death proteins in peripheral blood lymphocytes of patients with indolent lymphoma.
Interventions
- DRUG autologous human tumor-derived HSPPC-96
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2000-03 |
| Est. Completion | 2005-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00081809
The ClinicalTrials.gov registry entry for NCT00081809 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Agenus, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which autologous human tumor-derived HSPPC-96 is the first listed.
NCT00081809 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00081809 about?
NCT00081809 is a clinical study titled "A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma". Primary Objectives: * To document the efficacy of treatment with autologous lymphoma-derived HSPPC-96 of selected patients with indolent lymphoma. The efficacy endpoints are: * the rate of complete and partial responses * the time to progression. Secondary Objectives: * To evaluate the safety and...
What is the current status of trial NCT00081809?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2000-03. Estimated completion is 2005-06.
What interventions are being tested in trial NCT00081809?
The interventions under investigation include: autologous human tumor-derived HSPPC-96 (DRUG).
Who is sponsoring clinical trial NCT00081809?
This trial is sponsored by Agenus, which has 24 total clinical trials registered on ClinicalTrials.gov.
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