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A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma

A Phase II Trial of Active Specific Immunotherapy in Patients With Indolent Lymphoma Using Autologous Lymphoma-Derived Heat Shock Protein-Peptide Complex (HSPPC-96)

NCT00081809•Agenus Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with previously treated or newly diagnosed follicular center cell grade I or grade II lymphoma, small lymphocytic lymphoma, MALT lymphoma, monocytoid B-cell lymphoma, Waldenstrom's macroglobulinemia, or marginal zone lymphoma with bidimensionally measurable disease;
•Part of the resected specimen must undergo routine pathologic examination to confirm the diagnosis of lymphoma. The remaining tissue must be used for the preparation of autologous HSPPC-96;
•Autologous HSPPC-96 vaccine must be successfully prepared and provided by the sponsor;
•A minimum of 2 grams of non-necrotic, resectable malignant lymphoma for HSPPC-96 preparation;
•Bidimensionally measurable disease in at least one location other than the resected lymphoid tissue;
•Life expectancy of at least 16 weeks;
•Zubrod performance status of less then or equal to 2;
•Adequate bone marrow function;
•Adequate hepatic function;
•Adequate renal function;
+8 more criteria

Exclusion Criteria

•Patients with active or prior history of central nervous system lymphoma;
•Patients with serious intercurrent medical illnesses, requiring hospitalization;
•Patients with a history of primary or secondary immunodeficiency (other than related to the malignant lymphoma because treatment is dependent on functional immune system) or patients taking immunosuppressive drugs such as systemic corticosteroids;
•Women who are pregnant or lactating;
•Patients participating in another clinical trial;
•Patients receiving growth factors of any kind, including G-CSF, GM-CSF, or Epogen;
•Patients with bulky disease, defined as greater than 10 cm in diameter;
•Patients with positive HIV antibody;
•Patients with more than 4 previous treatment regimens will be excluded.

Locations (1)

M.D. Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

March 1, 2000

Primary Completion Date

June 1, 2005

Completion Date

June 1, 2005

Last Updated

September 28, 2023

Enrollment

Estimated participants

Conditions

Lymphoma, FollicularLymphoma, Small Lymphocytic

Interventions

autologous human tumor-derived HSPPC-96

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma

Inclusion Criteria

Exclusion Criteria

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