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Cancer Vaccine
Cancer Vaccine for Chronic Lymphocytic Leukemia
Phase 1
Waitlist Available
Led By Shuo Ma, MD, PhD
Research Sponsored by XEME Biopharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year.
Awards & highlights
Study Summary
This trial is testing a cancer vaccine to see if it is safe and effective in treating patients with previously untreated chronic lymphocytic leukemia.
Who is the study for?
Adults with untreated chronic lymphocytic leukemia (CLL) showing disease progression but not severe enough to require immediate treatment. Participants must have a certain level of white blood cells, be in good physical condition, and have normal kidney and liver function. Women who can bear children and sexually active men must use contraception. Those with other cancers, immune diseases, or infections that could affect the trial are excluded.Check my eligibility
What is being tested?
The trial is testing a new vaccine therapy called Oncoquest-CLL for CLL patients. It uses liposomes with cancer cell extracts and interleukin-2 to potentially stimulate the body's immune system to attack leukemia cells.See study design
What are the potential side effects?
Possible side effects may include reactions at the injection site, flu-like symptoms such as fever or chills due to immune activation, fatigue from the body's response to treatment, and potential autoimmune responses where the body attacks its own cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility in terms of vaccine delivery.
Feasibility in terms of vaccine production.
Incidence of adverse events graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Secondary outcome measures
Change in absolute lymphocyte count.
Change in lymphocyte doubling time.
Clinical response evaluated using IWCLL2008 guidelines.
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Oncoquest-CLL vaccine treatmentExperimental Treatment1 Intervention
Patients receive Oncoquest-CLL vaccine subcutaneously on Day 1 and 15, and then monthly for 3 months in the absence of disease progression or unacceptable toxicity.
Find a Location
Who is running the clinical trial?
XEME Biopharma Inc.Lead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,341 Total Patients Enrolled
Shuo Ma, MD, PhDPrincipal InvestigatorNorthwestern University
2 Previous Clinical Trials
53 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Patients must have evidence of disease progression as demonstrated by an increase of more than 50% in lymphocytosis since diagnosis and/or lymphadenopathy and a lymphocyte doubling time of more than 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Oncoquest-CLL vaccine treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available positions in this experimentation for participants?
"Unfortunately, the clinical trial information hosted on clinicialtrials.gov implies that this particular study is not accepting new enrollees at present. It was initially announced in October 2013 and modified most recently in April 2021; although it has ceased recruitment for now, there are 1523 other medical trials actively recruiting participants."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
How old are they?
65+
What site did they apply to?
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
What portion of applicants met pre-screening criteria?
Met criteria
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