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

April 7, 2021 updated by: XEME Biopharma Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 of the Oncoquest-L vaccine. Patients will receive subcutaneous injections consisting of their autologous tumor-derived Oncoquest-L vaccine starting at approximately 4 to 8 weeks after the biopsy. The first two doses will be given at a 2-week interval and the remaining 3 doses at monthly intervals. Patients will be monitored for response by performing imaging studies at baseline and 1 month after the fifth vaccination (Week 19). Additional imaging studies will be performed every 3 months for the first year and every 6 months during the second year until relapse or disease progression whichever occurs sooner.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Southeastern Regional Medical Center at CTCA
        • Contact:
          • Karen Rados
          • Phone Number: 770-400-6629

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Oncoquest-L vaccine
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.
Biological: Oncoquest-L vaccine
Patients will receive a total of 5 single administrations 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. For each vaccination, a total of 1.0 mL of vaccine will be administered, divided into 2 subcutaneous injections of 0.5 mL each at 2 different injection sites.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall tumor response rate
Time Frame: Up to 2 years
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.
Up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of complete and partial tumor response rates
Time Frame: Up to 2 years
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.
Up to 2 years
Assessment of time until initiation of radiotherapy or systemic therapy
Time Frame: Up to 2 years
Up to 2 years
Safety evaluation will include frequency, severity, and relationship of adverse events to vaccination; vital signs (blood pressure, respiration, pulse, and temperature); and laboratory test results (including, hematology and clinical chemistry)
Time Frame: From the time of informed consent up to 2 years
Safety parameters (e.g., adverse events, vital signs, and laboratory test results) will be recorded from the time patient signs informed consent, at every clinic visit during study treatment, 4 weeks after the 5th vaccination, and thereafter every 3 months during the 1st year and then every 6 months during the 2nd year.
From the time of informed consent up to 2 years
Tests to measure tumor-specific antibody production and T cell and B cell responses to vaccination
Time Frame: From 8 weeks prior to the 1st vaccination to Week 19 following the 1st vaccination.
Antibody production will be reported as increased titers of antibodies, B cells will be expressed as % B cell populations, T cell responses will be expressed as increases of tumor-specific T cells and changes in expression and quantity of cytokines (proteins that indicate changes in the immune response). Blood samples will be collected within 8 weeks prior to the 1st vaccination (baseline); within 7 days prior to the 5th vaccination; and 4 weeks after the 5th vaccination.
From 8 weeks prior to the 1st vaccination to Week 19 following the 1st vaccination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
XEME Biopharma Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brion Randolph, MD, Southeastern Regional Medical Center at Cancer Treatment Centers of America

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • X13-21008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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