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The objective of this phase II study is to evaluate the efficacy and safety of BR101801 in patients with peripheral T-cell lymphoma(PTCL).
This phase II study will evaluate the efficacy and safety of single-dose BR101801 once daily in patients with peripheral T-cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BR101801 (Bosmolisib) | Experimental | Patients will receive BR101801 capsules orally, QD in 28-day cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR101801 | Drug | Patients will receive 200mg capsules (100mg+100mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria | Up to 2 years | |
| Overall Survival (OS) | Up to 2 years | |
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Key Inclusion Criteria:
The ECOG performance status ≤ 2.
Life expectancy more than 3 months.
Patients with relapsed and/or refractory to standard therapy or are intolerance to standard therapy diagnosed with 2022 World Health Organization (WHO) classification
Patients currently requiring systemic therapy at the investigator's discretion.
Patients with a lesion measuring 1.5 cm or more in its longest transverse diameter, as determined by CT, PET/CT or MRI scans according to the 2014 Lugano criteria.
Key Exclusion Criteria:
The presence of overt leptomeningeal or active central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks.
Impaired cardiac function or clinically significant cardiac disease.
Patients with interstitial pneumonia or history of drug-induced interstitial pneumonia/pneumonitis.
For patients with lymphoma:
Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (>20 mg/day prednisone or equivalent).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shinyoung Oh | Contact | +82 2-708-8000 | syoh@boryung.co.kr |
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| Disease Control Rate (DCR) |
| Up to 2 years |
| Duration of Response (DOR) | Up to 2 years |
| Progression-free Survival (PFS) | Up to 2 years |
| Time to Tumor Progression (TTP) | Up to 2 years |
| Quality of life assessment Using the EQ-5D-5L assessment | European quality of life 5 dimensions questionnaire. The values is 0 to 1, whereby 0 indicates death and 1 perfect health | Every 2 cycles for up to 24 months (each cycle is 28 days) |
| Quality of life assessment Using EORTC QLQ-C30 assessment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QLQ-C30). All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. | Every 2 cycles for up to 24 months (each cycle is 28 days) |
| Plasma Concentration of BR101801 (Bosmolisib) | Blood samples were taken for the analyses of BR101801 in plasma at designated time points. | Cycle 2 Day 1 and Day 1 of Cycle 3 (each cycle is 28 days) |
| Adverse events | Approximately 24 months after a consent to the participation |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |