Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Follicular | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Small Lymphocytic | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous human tumor-derived HSPPC-96 | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
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