NCT05672355 A Vaccine Booster (GEO-CM04S1) for the Prevention of COVID-19 in Patients With Chronic Lymphocytic Leukemia
| NCT ID | NCT05672355 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | City of Hope Medical Center |
| Condition | Chronic Lymphocytic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2029-01-12 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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.
Eligibility Criteria
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) =
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.