Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT02194751
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02194751
Study Brief:
Protocol Section:
NCT02194751