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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • BR101801

    Drug

    Patients will receive 200mg capsules (100mg+100mg)

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: BR101801 (Bosmolisib)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Overall Survival (OS)

Time frame
Up to 2 years
3

Disease Control Rate (DCR)

Time frame
Up to 2 years
4

Duration of Response (DOR)

Time frame
Up to 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boryung Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: