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NCT03454165 · ClinicalTrials.gov registry record · Phase 1
A Study of BNC105P Combined With Ibrutinib
A Phase 1 study of Chronic Lymphocytic Leukemia, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT03454165 is a Phase 1 study of Chronic Lymphocytic Leukemia that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 6 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03454165, a Phase 1 study of Chronic Lymphocytic Leukemia, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
A Phase I Trial of BNC105P in combination with BTK inhibitor ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia(CLL). This study proposes that ibrutinib will have far greater efficacy when it is combined with drugs that kill the CLL cells in peripheral circulation, thereby preventing them from returning to the protective lymph node niche. The study will establish the maximum tolerated dose(MTD) of the combination of BNC105P with ibrutinib, characterize the pharmacodynamic effects of BNC105P alone and in combination with ibrutinib in CLL cells, and provide preliminary assessment of the efficacy of the combination in CLL. The study consists of a Screening Period with baseline tumor assessment before BNC105P administration, a Treatment Period with up to six 21-day cycles and Follow-up Period. Subjects will receive a total of six cycles of therapy unless treatment is discontinued
Conditions Studied
Interventions
- COMBINATION_PRODUCT BNC105P
- COMBINATION_PRODUCT Ibrutinib
Study Locations (1)
New Hampshire
- Dartmouth-Hitchcock Medical Center - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-03-09 |
| Est. Completion | 2021-01-14 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03454165
The ClinicalTrials.gov registry entry for NCT03454165 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (97% lower). The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which BNC105P is the first listed.
NCT03454165 reports 1 study location spanning 1 distinct geographic area - top geographies include New Hampshire.
Frequently Asked Questions
What is clinical trial NCT03454165 about?
NCT03454165 is a clinical study titled "A Study of BNC105P Combined With Ibrutinib". A Phase I Trial of BNC105P in combination with BTK inhibitor ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia(CLL). This study proposes that ibrutinib will have far greater efficacy when it is combined with drugs that kill the CLL cells in peripheral circulation, thereby p...
What is the current status of trial NCT03454165?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2018-03-09. Estimated completion is 2021-01-14.
What conditions does trial NCT03454165 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT03454165?
The interventions under investigation include: BNC105P (COMBINATION_PRODUCT), Ibrutinib (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03454165?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03454165 being conducted?
This trial has 1 study location across New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.