A Vaccine Booster (GEO-CM04S1) for the Prevention of COVID-19 in Patients With Chronic Lymphocyti… (NCT05672355) | Clinical Trial Compass
SuspendedPhase 2
A Vaccine Booster (GEO-CM04S1) for the Prevention of COVID-19 in Patients With Chronic Lymphocytic Leukemia
Stopped: Resources
United States80 participantsStarted 2023-08-01
Plain-language summary
This phase II trial compares the effect of the GEO-CM04S1 vaccine with the current standard of care vaccine in preventing COVID-19 infections in patients with chronic lymphocytic leukemia (CLL). The GEO-CM04S1 vaccine uses a modified vaccinia virus (MVA) backbone that may be more effective at boosting COVID-19 immunity in patients with poor immune responses. MVA strongly induces T cell expansion (infection fighting blood cells) even in the background of a suppressed immune system, which is the case in the targeted CLL patient population. Using the GEO-CM04S1 vaccine may be more effective at preventing COVID-19 infection in patients diagnosed with CLL.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented informed consent of the participant and/or legally authorized representative
* Age: \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) =\< 1
* Histologically confirmed diagnosis of CLL according to World Health Organization (WHO) classification
* Prior COVID-19 Vaccination (2 or more Pfizer or Moderna) with last injection \>= 3 months prior
* Fully recovered from the acute toxic effects (except alopecia) to =\< Grade 1 to prior anti-cancer therapy
* White Blood Cells (WBC) \>= 1,000/mm\^3 (To be performed within 14 days prior to Day 1 of protocol therapy)
* Platelets \>= 50,000/mm\^3 (To be performed within 14 days prior to Day 1 of protocol therapy)
* Total bilirubin =\< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) (To be performed within 14 days prior to Day 1 of protocol therapy)
* Aspartate aminotransferase (AST) =\< 2.5 x ULN (To be performed within 14 days prior to Day 1 of protocol therapy)
* Alanine transaminase (ALT) =\< 2.5 x ULN (To be performed within 14 days prior to Day 1 of protocol therapy)
* Creatinine clearance \<1.5 ULN (To be performed within 14 days prior to Day 1 of protocol therapy)
* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (To be performed within 14 days prior to Day 1 of protocol therapy)
* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* Agreement by females and males of childbearing potenti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is currently suspended, can you find out why enrollment was paused and whether it's expected to resume — and does that affect whether this approach might still be worth considering for me?
2Because CLL can weaken the immune system's ability to respond to standard COVID-19 vaccines, is a specialized vaccine booster like GEO-CM04S1 something my care team thinks could be more appropriate for my situation than getting another standard booster?
3This is a Phase 2 trial focused on measuring T cell responses, which means it's still building the evidence base — what does that mean for what's currently known about how safe and effective this vaccine booster actually is for CLL patients?
4Given that the trial is measuring T cell response as its main outcome, can you explain what that means for real-world protection against COVID-19, and how confident researchers are that a stronger T cell response would translate into meaningful benefit for someone like me?
5Are there other ways to protect myself against COVID-19 right now — like antiviral medications or adjusted vaccination schedules — that my care team would recommend while this trial remains suspended?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.