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NCT05417165 · ClinicalTrials.gov registry record · Phase 2
Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia
A Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Seema Bhat.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT05417165: Recruiting Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Seema Bhat.
NCT05417165 is a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that is actively recruiting participants, run by Seema Bhat. The registered enrollment target is 80 participants, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05417165, a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, is actively recruiting participants, sponsored by Seema Bhat.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial compares the effect of initial vaccination (PCV20 followed by PSV23) with yearly vaccinations of PSV23 to the standard 5 year vaccination in patients with chronic lymphocytic leukemia. At present chronic lymphocytic leukemia patients are poorly protected by anti-pneumococcal vaccination. Current vaccination schedule for chronic lymphocytic leukemia patients is based on general recommendations in immunocompromised patients (initial vaccination with PCV13 followed by one dose of PSV23 after an interval of two months, followed by revaccination at 5 years). Giving patients frequent immunization as compared to 5 year immunization may result in higher protective titers in patients.
Primary Outcome
Serotype to be measured are 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A 19 F and 23F using the enzyme-linked immunosorbent assay (ELISA) method.
Conditions Studied
Interventions
- BIOLOGICAL Pneumococcal 20-valent Conjugate Vaccine
- BIOLOGICAL Pneumococcal Polyvalent Vaccine
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2023-09-29 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 2 |
What NCT05417165 shows while recruiting
NCT05417165 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (56% lower).
The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Pneumococcal 20-valent Conjugate Vaccine is the first listed.
NCT05417165 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05417165 about?
NCT05417165 is a clinical study titled "Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia". This phase II trial compares the effect of initial vaccination (PCV20 followed by PSV23) with yearly vaccinations of PSV23 to the standard 5 year vaccination in patients with chronic lymphocytic leukemia. At present chronic lymphocytic leukemia patients are poorly protected by anti-pneumococcal vacc...
What is the current status of trial NCT05417165?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2023-09-29. Estimated completion is 2026-10-31.
What conditions does trial NCT05417165 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT05417165?
The interventions under investigation include: Pneumococcal 20-valent Conjugate Vaccine (BIOLOGICAL), Pneumococcal Polyvalent Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05417165?
This trial is sponsored by Seema Bhat, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05417165 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05417165's enrollment target sits among peer trials
80 74th of 187 higher than 113 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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