Clinical trial · Interventional
Oncoquest-L Vaccine in Patients With Previously Untreated Stage III or IV, Asymptomatic, Non-bulky Follicular Lymphoma
- 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)
This Phase II trial studies the overall tumor response of vaccine therapy in patientswith previously untreated Stage III or IV, asymptomatic, non-bulky follicular lymphoma. The vaccine contains an extract of the patient's own cancer cells and the immunostimulant protein, interleukin-2 (IL-2). It is hoped that when injected under the skin, the vaccine will enable the patient's immune system to recognize and destroy the cancer cells. The trial will also assess the safety of the vaccine, the time from vaccine treatment until the patient requires another type of anti-lymphoma treatment, progression-free survival, and the anti-tumor immune response.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oncoquest-L vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oncoquest-L vaccine
- description
- Patients will receive a total of 5 single injections of Oncoquest-L; the first 2 doses administered will be separated by a 2-week interval and the remaining 3 doses will be administered each at 1-month intervals. With each dose of Oncoquest-L vaccine, the vaccine will be administered subcutaneously at 2 different sites in the upper arms or upper legs, with alternation of the injection sites with each administration.
- interventionNames
- Biological: Oncoquest-L vaccine
Primary outcomes (1)
- measure
- Overall tumor response rate
- timeFrame
- Up to 2 years
- description
- Tumor measurements will be performed at enrollment (baseline); then, tumor measurements and response assessments will occur 4 weeks after the 5th vaccination. Thereafter, tumor measurements and response assessments will occur every 3 months during the 1st year and then every 6 months during the 2nd year until relapse or disease progression, whichever occurs first.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Follicular lymphoma (FL) grade 1, 2, or 3a diagnosed within 12 months of study enrollment 2. Age ≥ 18 years 3. Previously untreated Stage III or IV FL 4. A single peripheral lymph node of at least 1 x 1 cm in size accessible for excisional biopsy 5. Measurable or evaluable disease after obtaining tissue for vaccine production 6. Performance status (ECOG) of 0 or 1 7. Asymptomatic disease without B symptoms or severe pruritus 8. Low tumor burden as defined by the following criteria: * Normal lactic dehydrogenase * Largest tumor mass \< 7 cm * Involvement of \< 3 nodal sites with a diameter ≥ 3 cm * No clinically significant pleural effusion or ascites * Spleen size of ≤ 16 cm by CT scan * Circulating tumor cells \< 5.0 x 109/L * No clinically significant organ compression 9. Adequate hematopoietic parameters: * Absolute neutrophil count ≥ 1.5 x 109/L * Platelet count ≥ 100 x 109/L * Hemoglobin ≥ 10 g/dL 10. Serum creatinine ≤ 2 x upper limit of normal (ULN) 11. Total bilirubin ≤ 2 x ULN unless considered secondary to Gilbert's syndrome. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase ≤ 2 x ULN 12. Fertile patients must use effective contraception during and for 12 months after completion of therapy 13. For fertile female patients, a negative pregnancy test result at enrollment Exclusion Criteria: 1. Active HIV, hepatitis B, hepatitis C or other active infectious process 2. Pregnant or nursing women 3. Patients with previous history of malignancy within the past 2 years except curatively treated squamous or basal cell carcinoma of the skin or curatively treated carcinoma in situ of the cervix. 4. Any medical or psychiatric condition that in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment 5. Concurrent treatment with immunosuppressive therapy
References
Publications (0)
Data not yet available