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Not yet recruiting NCT07180771

A Study of Bosmolisib (BR101801) in Participants With R/R PTCL.

Phase II Interventional Peripheral T Cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BR101801.
Who it may be relevant to
Registry conditions: Peripheral T Cell Lymphoma. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase II, Single-arm, Multicenter, Open Label Study to Evaluate Efficacy and Safety of BR101801 Monotherapy in Relapsed/Refractory Peripheral T-cell Lymphoma Patients

Overview

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

  • Drug BR101801
    Patients will receive 200mg capsules (100mg+100mg)

Primary outcome measures

  • 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 outcome measures (10)
  • 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 [Time frame: Every 2 cycles for up to 24 months (each cycle is 28 days)]
  • Quality of life assessment Using EORTC QLQ-C30 assessment [Time frame: Every 2 cycles for up to 24 months (each cycle is 28 days)]
  • Plasma Concentration of BR101801 (Bosmolisib) [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]

Eligibility criteria

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
  • Peripheral T-cell lymphoma, not otherwise specified
  • Nodal TFH cell lymphoma, angioimmunoblastic-type
  • Nodal TFH cell lymphoma, follicular-type
  • Nodal TFH cell lymphoma, NOS
  • 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.

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:
  • 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.
  • Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (>20 mg/day prednisone or equivalent).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07180771 · BR-101801-CT-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗