Peripheral T Cell Lymphoma
Conditions
Keywords
PTCL, Bosmolisib, BR101801, PI3K inhibitor, DNA-PK
Brief summary
The objective of this phase II study is to evaluate the efficacy and safety of BR101801 in patients with peripheral T-cell lymphoma(PTCL).
Detailed description
This phase II study will evaluate the efficacy and safety of single-dose BR101801 once daily in patients with peripheral T-cell lymphoma.
Interventions
DRUGBR101801
Patients will receive 200mg capsules (100mg+100mg)
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. The ECOG performance status ≤ 2. 2. Life expectancy more than 3 months. 3. Patients with relapsed and/or refractory to standard therapy or are intolerance to standard therapy diagnosed with 2022 World Health Organization (WHO) classification * Peripheral T-cell lymphoma, not otherwise specified * Nodal TFH cell lymphoma, angioimmunoblastic-type * Nodal TFH cell lymphoma, follicular-type * Nodal TFH cell lymphoma, NOS 4. Patients currently requiring systemic therapy at the investigator's discretion. 5. 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
1. 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. 2. Impaired cardiac function or clinically significant cardiac disease. 3. Patients with interstitial pneumonia or history of drug-induced interstitial pneumonia/pneumonitis. 4. For patients with lymphoma: * Systemic antineoplastic therapy (including cytotoxic chemotherapy, alfa-interferon \[INF\], and toxin immunoconjugates) or any experimental therapy within 3 weeks or 5 half lives, whichever is shorter, before the first dose of study treatment. * Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment. * Unconjugated monoclonal antibody therapies \< 6 weeks before the first dose of study treatment. 5. Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (\>20 mg/day prednisone or equivalent).
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | Every 2 cycles for up to 24 months (each cycle is 28 days) | European quality of life 5 dimensions questionnaire. The values is 0 to 1, whereby 0 indicates death and 1 perfect health |
| Quality of life assessment Using EORTC QLQ-C30 assessment | Every 2 cycles for up to 24 months (each cycle is 28 days) | 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. |
| Plasma Concentration of BR101801 (Bosmolisib) | Cycle 2 Day 1 and Day 1 of Cycle 3 (each cycle is 28 days) | Blood samples were taken for the analyses of BR101801 in plasma at designated time points. |
| Adverse events | Approximately 24 months after a consent to the participation | — |
Contacts
CONTACTShinyoung Oh
Outcome results
None listed