BR101801 in Adult Patients With Advanced Hematologic Malignancies( Phase I)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- B Cell Lymphoma
- Chronic Lymphocytic Leukemia
- Diffuse Large B Cell Lymphoma
- Follicular Lymphoma
- Marginal Zone Lymphoma
- Peripheral T Cell Lymphoma
- Small Lymphocytic Leukemia
- Waldenstrom Macroglobulinemia
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Phase Ia (Dose Escalation) Primary Objectives To assess the safety and tolerability of BR101801 in patients with relapsed/refractory B-cell lymphoma, CLL/SLL, and PTCL. To assess DLT and to determine the MTD and/or the RDE dose for BR101801 when administered orally on a daily schedule in 4-week cycl...
Phase Ia (Dose Escalation) Primary Objectives To assess the safety and tolerability of BR101801 in patients with relapsed/refractory B-cell lymphoma, CLL/SLL, and PTCL. To assess DLT and to determine the MTD and/or the RDE dose for BR101801 when administered orally on a daily schedule in 4-week cycles until disease progression. SecondaryObjectives To characterize the plasma and urine PK of BR101801. To assess the preliminary antitumor activity of BR101801. Phase Ib (Dose Expansion) Primary Objectives •To assess the safety and tolerability of BR101801 at the RDE dose in patients with relapsed and/or refractory B-cell lymphoma, CLL/SLL, and PTCL. SecondaryObjectives To assess clinical activity of BR101801 when administered orally on a daily schedule in 4-week cycles until disease progression. To assess the plasma PK of BR101801 OUTLINE: This is a Phase I, multi-center, open-label, FIH study. Safety monitoring committee (SMC) will be responsible for safety oversight.
Tracking Information
- NCT #
- NCT04018248
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: TM Kim, M.D, Ph.D Seoul National University Hospital Principal Investigator: SJ Kim, M.D, Ph.D Samsung Medical Center Principal Investigator: DH Yoon, M.D, Ph.D Asan Medical Center Principal Investigator: Jorge Chaves, M.D, Ph.D Northwest Medical Specialities, PLLC Principal Investigator: Emily Curran, M.D, Ph.D University of Cincinnati
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