A Phase 2 interventional study of BR101801 in Peripheral T Cell Lymphoma, sponsored by Boryung Pharmaceutical Co., Ltd. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 2, Interventional, and Treatment
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.
372 studies on the registry are indexed under Lymphoma, T-Cell, Peripheral; 110 are open to participants now.
This study's planned enrollment of 44 is close to the median of 44 across 328 interventional studies indexed under Lymphoma, T-Cell, Peripheral.
Browse Lymphoma, T-Cell, Peripheral studies →Boryung Pharmaceutical Co., Ltd is the lead sponsor of 143 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Patients with to standard therapy or are intolerance to standard therapy diagnosed with 2022 World Health Organization (WHO) classification
Key Exclusion Criteria:
For patients with lymphoma:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive BR101801 capsules orally, QD in 28-day cycles
Drug: BR101801
Patients will receive 200mg capsules (100mg+100mg)
Also known as: Bosmolisib
Confirmed Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria
Time frame: Up to 2 years
Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Progression-free Survival (PFS)
Time frame: Up to 2 years
Time to Tumor Progression (TTP)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Cycle 2 Day 1 and Day 1 of Cycle 3 (each cycle is 28 days)
Adverse events
Time frame: Approximately 24 months after a consent to the participation
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Lymphoma, T-Cell, Peripheral →
Boryung Pharmaceutical Co., Ltd →