Study on Oncoquest-L Vaccine for Patients with Untreated Stage III or IV, Asymptomatic, Non-bulky Follicular Lymphoma

Sponsor: XEME Biopharma Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02194751

Provider View

This clinical trial is testing a new vaccine made from a patient's own cancer cells to see if it can help the immune system fight follicular lymphoma, a type of blood cancer. The study will also check the safety of the vaccine and how long patients can go without needing other treatments.

Patient Parameters

Program Overview

This Phase II study is exploring a vaccine therapy for patients with Stage III or IV follicular lymphoma who have not yet received treatment and do not have symptoms. The vaccine is made from the patient's own cancer cells and a protein called interleukin-2 (IL-2) to help the immune system recognize and attack the cancer. The study will look at how well the vaccine works in shrinking tumors, its safety, and how long patients can go without needing other treatments. It will also measure the immune system's response to the vaccine.

Description

In this study, patients will first have a biopsy to remove a lymph node containing cancer cells. These cells will be used to create the Oncoquest-L vaccine. About 4 to 8 weeks after the biopsy, patients will start receiving the vaccine through injections under the skin. The first two doses are given two weeks apart, and the next three doses are given monthly. Doctors will use imaging tests to monitor the cancer's response to the vaccine at the start and one month after the last dose. Additional scans will be done every three months in the first year and every six months in the second year, or until the cancer progresses.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with follicular lymphoma (FL) grade 1, 2, or 3a within the last 12 months
  • Age 18 or older
  • Have not received any treatment for Stage III or IV FL
  • Have a lymph node at least 1 x 1 cm in size that can be biopsied
  • Have measurable or evaluable disease after tissue is taken for the vaccine
  • Good overall health with a performance status of 0 or 1
  • No symptoms like fever, weight loss, or severe itching
  • Low tumor burden, meaning:
    • Normal lactic dehydrogenase levels
    • Largest tumor is less than 7 cm
    • Less than 3 lymph nodes with a diameter of 3 cm or more
    • No significant fluid buildup in the chest or abdomen
    • Spleen size is 16 cm or less on a CT scan
    • Low number of circulating tumor cells
    • No significant organ compression
  • Adequate blood cell counts:
    • Neutrophil count of at least 1.5 x 109/L
    • Platelet count of at least 100 x 109/L
    • Hemoglobin level of at least 10 g/dL
  • Normal kidney function with serum creatinine levels within twice the normal limit
  • Normal liver function tests, unless due to Gilbert's syndrome
  • Fertile patients must use effective birth control during and for 12 months after treatment
  • Fertile female patients must have a negative pregnancy test at enrollment

Exclusion Criteria

  • Active infections like HIV, hepatitis B, or hepatitis C
  • Pregnant or breastfeeding women
  • History of another cancer in the past 2 years, except for certain skin or cervical cancers
  • Any medical or psychiatric condition that could affect the ability to tolerate treatment
  • Currently receiving immunosuppressive therapy

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