Oncoquest-L Vaccine in Patients With Previously Untreated Stage III or IV, Asymptomatic, Non-bulky Follicular Lymphoma

Status unconfirmed · Phase 2

Conditions studied: Follicular Lymphoma

In brief

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.

Key facts

Study ID

NCT02194751

Run by

XEME Biopharma Inc.

People needed

30

Starts

2021-07-01

Expected to finish

2026-06-01

Last updated by the study team

2021-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Southeastern Regional Medical Center at CTCA — Newnan, Georgia, United States

Full record on ClinicalTrials.gov

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