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NCT03771157 · ClinicalTrials.gov registry record · Early Phase 1
Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors
A Early Phase 1 study of Chronic Lymphocytic Leukemia (CLL) and Waldenstrom Macroglobulinemia (WM), sponsored by University of Rochester.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT03771157: Completed Early Phase 1 study of Chronic Lymphocytic Leukemia (CLL) and Waldenstrom Macroglobulinemia (WM), sponsored by University of Rochester.
NCT03771157 is a Early Phase 1 study of Chronic Lymphocytic Leukemia (CLL) and Waldenstrom Macroglobulinemia (WM) that has completed, run by University of Rochester. The registered enrollment target is 33 participants, below the 190-participant average among 29 other Chronic Lymphocytic Leukemia (CLL) trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03771157, a Early Phase 1 study of Chronic Lymphocytic Leukemia (CLL) and Waldenstrom Macroglobulinemia (WM), has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of the study is to assess the capability of a patient with Chronic Lymphocytic Leukemia (CLL) or Waldenström Macroglobulinemia (WM) to generate an immune response to the Shingrix vaccine under first-line BTK inhibitors.
Primary Outcome
Vaccine response, as determined by blood antibody levels to the varicella virus glycoprotein E subunit (anti-gE); Baseline is defined as pre-vaccination anti-gE titer in seropositive subjects, and the lower limit of detection in seronegative subjects
Conditions Studied
Interventions
- DRUG Shingrix vaccine
Study Locations (1)
New York
- University of Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2019-02-01 |
| Est. Completion | 2022-08-03 |
| Phase | Early Phase 1 |
What the finished NCT03771157 record still lists
NCT03771157 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 190-participant average among 29 other Chronic Lymphocytic Leukemia (CLL) trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Chronic Lymphocytic Leukemia (CLL) appearing as the primary indexed condition, and to 1 intervention - of which Shingrix vaccine is the first listed.
NCT03771157 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03771157 about?
NCT03771157 is a clinical study titled "Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors". The primary objective of the study is to assess the capability of a patient with Chronic Lymphocytic Leukemia (CLL) or Waldenström Macroglobulinemia (WM) to generate an immune response to the Shingrix vaccine under first-line BTK inhibitors.
What is the current status of trial NCT03771157?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 33 participants. The study started on 2019-02-01. Estimated completion is 2022-08-03.
What conditions does trial NCT03771157 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia (CLL), Waldenstrom Macroglobulinemia (WM).
What interventions are being tested in trial NCT03771157?
The interventions under investigation include: Shingrix vaccine (DRUG).
Who is sponsoring clinical trial NCT03771157?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03771157 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia (CLL)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03771157's enrollment target sits among peer trials
33 23rd of 29 higher than 7 of 29 other Chronic Lymphocytic Leukemia (CLL) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia (CLL) 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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