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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04018248
The ClinicalTrials.gov registry entry for NCT04018248 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 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 (86% lower). The listed sponsor is Boryung Pharmaceutical Co., which has 1 total studies on file at ClinicalTrials.gov.
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 reports 9 study locations spanning 4 distinct geographic areas - top geographies include 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.
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