Lymphoma, Follicular Clinical Trial
Official title:
A Phase II Trial of Active Specific Immunotherapy in Patients With Indolent Lymphoma Using Autologous Lymphoma-Derived Heat Shock Protein-Peptide Complex (HSPPC-96)
Verified date | September 2023 |
Source | Agenus Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | June 2005 |
Est. primary completion date | June 2005 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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; - Signed written informed consent; - Patients of child-bearing potential must practice contraception, which is adequate in the opinion of the Principal Investigator; - Patients of child-bearing potential must have a negative serum pregnancy test prior to entry into the study and must not be lactating; - Patients must be willing to be followed at the M. D. Anderson Cancer Center during the course of treatment and follow-up; - Electrocardiogram if none performed in the prior six months; - Patients must have no chemotherapy, immunotherapy, radiotherapy, or experimental anti-cancer therapy within six weeks prior to starting autologous HSPPC-96 administration; - Patients must have fully recovered from prior anti-cancer therapy; - Tumor measurements and staging no more than 4 weeks prior to receiving the first dose of autologous HSPPC-96. 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. |
Country | Name | City | State |
---|---|---|---|
United States | M.D. Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Agenus Inc. |
United States,
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01950273 -
Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab as First Line-treatment in Patients With Low Tumor Burden Follicular Lymphoma
|
Phase 1 | |
Completed |
NCT00930514 -
A Pharmacokinetic Study of Subcutaneous and Intravenous Rituximab in Participants With Follicular Lymphoma
|
Phase 1 | |
Completed |
NCT02472756 -
Open, Noninterventional Trial of MabThera in Combination With Chemotherapy (CVP, CHOP or FCM) in Patients With Relapsed/Refractory Follicular Lymphoma
|
N/A | |
Withdrawn |
NCT00319332 -
A Comparative Study Of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen
|
Phase 3 | |
Completed |
NCT00193492 -
A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma
|
Phase 2 | |
Withdrawn |
NCT00092274 -
Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma
|
Phase 1/Phase 2 | |
Completed |
NCT03087929 -
Follow-up Trial of Rituximab Interferon Transplant Trial: Study Drug-Rituximab and Alpha Interferon
|
N/A | |
Terminated |
NCT02413489 -
An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma
|
Phase 2 | |
Completed |
NCT00915096 -
Positron Emission Tomography (PET)-Scan in the Evaluation of High Tumor Burden Follicular Lymphoma
|
||
Recruiting |
NCT05849857 -
Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries
|
Phase 2 | |
Recruiting |
NCT05410418 -
Mosunetuzumab and Polatuzumab Vedotin for Untreated Follicular Lymphoma
|
Phase 2 | |
Terminated |
NCT01609036 -
An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Lymphoma
|
N/A | |
Completed |
NCT01234766 -
Bendamustine and Rituximab Followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma
|
Phase 2 | |
Completed |
NCT00849147 -
Bone Marrow Transplant From Partially Matched Donors and Nonmyeloablative Conditioning for Blood Cancers (BMT CTN 0603)
|
Phase 2 | |
Terminated |
NCT00384111 -
Phase 3 Study of Zevalin Following R-CVP in Previously Untreated Patients With Follicular Non Hodgkin's Lymphoma (NHL)
|
Phase 3 | |
Completed |
NCT03682796 -
Study of TRPH-222 in Patients With Relapsed and/or Refractory B-Cell Lymphoma
|
Phase 1 | |
Recruiting |
NCT04982471 -
Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
|
||
Active, not recruiting |
NCT02996773 -
Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine
|
Phase 1 | |
Terminated |
NCT00562965 -
Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)
|
Phase 3 | |
Active, not recruiting |
NCT00317096 -
FCM Versus R-FCM Followed by R-Maintenance or Observation Only
|
Phase 3 |