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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: Completed Phase 1 study of Chronic Lymphocytic Leukemia, sponsored by Dartmouth-Hitchcock Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The number of relapsed refractory chronic lymphatic leukemia patients, in cohorts of 3-6, who develop treatment related adverse effects from combined therapy with BNC105P and ibrutinib. The treatment related adverse events will be defined based on CTCAE v 4.0
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 |
What the finished NCT03454165 record still lists
NCT03454165 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
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 NCT03454165's enrollment target sits among peer trials
6 184th of 187 higher than 3 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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