A Study of Bosmolisib (BR101801) in Participants With R/R PTCL.
ConditionPeripheral T Cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorBoryung Pharmaceutical Co., Ltd
About this trial
The objective of this phase II study is to evaluate the efficacy and safety of BR101801 in patients with peripheral T-cell lymphoma(PTCL).
Eligibility criteria
Qualifiers
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
Peripheral T-cell lymphoma, not otherwise specified
Disqualifiers
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.
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.
Trial design
Treatments tested in this trial
- BR101801
Treatment groups
44 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov