Status:
NOT_YET_RECRUITING
Oncoquest-L Vaccine in Patients With Previously Untreated Stage III or IV, Asymptomatic, Non-bulky Follicular Lymphoma
Lead Sponsor:
XEME Biopharma Inc.
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ext...
Detailed Description
This is a single-arm open-label pilot Phase II study. Following informed consent, eligible subjects will undergo excisional biopsy of a lymphoma-containing lymph node for diagnosis and for generation ...
Eligibility Criteria
Inclusion
- Follicular lymphoma (FL) grade 1, 2, or 3a diagnosed within 12 months of study enrollment
- Age ≥ 18 years
- Previously untreated Stage III or IV FL
- A single peripheral lymph node of at least 1 x 1 cm in size accessible for excisional biopsy
- Measurable or evaluable disease after obtaining tissue for vaccine production
- Performance status (ECOG) of 0 or 1
- Asymptomatic disease without B symptoms or severe pruritus
- 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
- Adequate hematopoietic parameters:
- Absolute neutrophil count ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 10 g/dL
- Serum creatinine ≤ 2 x upper limit of normal (ULN)
- Total bilirubin ≤ 2 x ULN unless considered secondary to Gilbert's syndrome. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase ≤ 2 x ULN
- Fertile patients must use effective contraception during and for 12 months after completion of therapy
- For fertile female patients, a negative pregnancy test result at enrollment
Exclusion
- Active HIV, hepatitis B, hepatitis C or other active infectious process
- Pregnant or nursing women
- 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.
- Any medical or psychiatric condition that in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment
- Concurrent treatment with immunosuppressive therapy
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02194751
Start Date
July 1 2021
End Date
June 1 2026
Last Update
April 8 2021
Active Locations (1)
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1
Southeastern Regional Medical Center at CTCA
Newnan, Georgia, United States, 30265