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NCT04018248 · ClinicalTrials.gov registry record · Phase 1
BR101801 in Adult Patients With Advanced Hematologic Malignancies(Phase I)
A Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, sponsored by Boryung Pharmaceutical Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 9
- Study locations
NCT04018248: Completed Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, sponsored by Boryung Pharmaceutical Co..
NCT04018248 is a Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma that has completed, run by Boryung Pharmaceutical Co.. The registered enrollment target is 26 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (86% lower). The trial reports 9 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04018248, a Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, has completed, sponsored by Boryung Pharmaceutical Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 9
- Study locations
Study Summary
This is a Phase I, multi-center, open-label, FIH study comprising of 2 study parts (Phase Ia, Phase Ib). The Phase Ia (dose escalation) part of the study is designed to determine the safety, tolerability, and maximum tolerated dose (MTD)/recommended dose for expansion (RP2D) of BR101801 in subjects with relapsed/refractory B cell lymphoma, chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL), and peripheral T cell lymphoma (PTCL). The Phase Ib (dose expansion) part of the study is designed to assess tumor response and safety in specific advanced relapsed/refractory Peripheral T-cell lymphoma(PTCL) at a dose of BR101801 identified in Phase Ia. Once the RP2D has been determined in Phase Ia (dose escalation), Phase Ib (dose expansion) will commence.
Primary Outcome
The recommended dose is determined by the number of patients who experience a dose limiting toxicity (DLT).
Conditions Studied
Interventions
- DRUG BR101801 (Phase Ia)
- DRUG BR101801 (Phase Ib)
Study Locations (9)
Other
- Inje University Busan Paik Hospital - Busan
- Asan Medical Center - Seoul
- Samsung Medical Center - Seoul
- Seoul national university hospital - Seoul
- Severance Hospital, Yonsei University Health System - Seoul
Gyeonggi-do
- National Cancer Center - Goyang-si
- Seoul National University Bundang Hospital - Seongnam-si
Michigan
- Henry Ford Hospital - Detroit
Jeollanam-do
- Chonnam National University Hwasun Hospital - Hwasun
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-04-21 |
| Est. Completion | 2023-09-21 |
| Phase | Phase 1 |
What the finished NCT04018248 record still lists
NCT04018248 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (86% lower).
The record links to 8 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which BR101801 (Phase Ia) is the first listed.
NCT04018248 lists 9 locations in 4 states (Other, Gyeonggi-do, Michigan).
Frequently Asked Questions
What is clinical trial NCT04018248 about?
NCT04018248 is a clinical study titled "BR101801 in Adult Patients With Advanced Hematologic Malignancies(Phase I)". This is a Phase I, multi-center, open-label, FIH study comprising of 2 study parts (Phase Ia, Phase Ib). The Phase Ia (dose escalation) part of the study is designed to determine the safety, tolerability, and maximum tolerated dose (MTD)/recommended dose for expansion (RP2D) of BR101801 in subjects...
What is the current status of trial NCT04018248?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2020-04-21. Estimated completion is 2023-09-21.
What conditions does trial NCT04018248 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, B-cell Lymphoma.
What interventions are being tested in trial NCT04018248?
The interventions under investigation include: BR101801 (Phase Ia) (DRUG), BR101801 (Phase Ib) (DRUG).
Who is sponsoring clinical trial NCT04018248?
This trial is sponsored by Boryung Pharmaceutical Co., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04018248 being conducted?
This trial has 9 study locations across Michigan, Gyeonggi-do, Jeollanam-do. 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 NCT04018248's enrollment target sits among peer trials
26 147th of 187 higher than 40 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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