Lymphoma
Conditions
Keywords
Relapsed or refractory Cutaneous T Cell Lymphoma, Relapsed or refractory Peripheral T Cell Lymphoma
Brief summary
The primary purpose of this study is to evaluate the anti-tumor activity of TLN-254 monotherapy in participants with relapsed or refractory T-cell lymphoma.
Interventions
DRUGTLN-254
TLN-254 will be administered orally at a specified dose on specified days depending on treatment allocation.
Sponsors
Treeline Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age: 1. At least 18 years of age at the time of signing the informed consent form (ICF). Type of Participant and Disease Characteristics: 2. Cohort 1: Peripheral T-cell lymphoma (PTCL) that has relapsed after, or not responded to at least one prior systemic treatment regimen. Participants with Anaplastic large cell lymphoma (ALCL) should have received prior brentuximab vedotin treatment. * Nodal T-follicular helper (TFH) cell lymphoma angioimmunoblastic; Follicular helper T-cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma). * Nodal TFH cell lymphoma, follicular type; Follicular helper T-cell lymphoma, follicular type. * Nodal TFH cell lymphoma, not otherwise specified (NOS); Follicular helper T-cell lymphoma, NOS. * PTCL, NOS. * Anaplastic large-cell lymphoma, Alkaline phosphatase (ALK) positive. * Anaplastic large-cell lymphoma, ALK negative. Cohort 2: Relapsed/refractory CTCL which has relapsed after, or not responded to at least two prior systemic treatments. * Sezary syndrome * Mycosis fungoides 3. Participant must have measurable disease at study entry. 4. Freshly biopsied or archival tissue available. Diagnostic Assessments: 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 6. Adequate organ function. Contraception: 7. Participants must accept and follow the pregnancy prevention plan.
Exclusion criteria
Medical Conditions: 1. Participants must not have prior systemic anti-cancer treatment less than or equal to (≤) 5 half-lives or 4 weeks, allogeneic SCT≤90 days or autologous SCT ≤60 days prior to study intervention initiation. 2. Participants must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study. 3. Current or past history of central nervous system (CNS) involvement. Other Exclusions: * Pregnant or lactating women. * Unable to swallow tablets.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Objective Response | Up to 2 years |
| Percentage of Participants With CR | Up to 2 years |
| Percentage of Participants With PR | Up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 2 years |
| Number of Participants With Severity of TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 | Up to 2 years |
| Plasma concentrations of TLN-254 | Day 1 of Cycle 1 and Day 1 of each even numbered Cycle for up to 2 years (Each Cycle length =28 days) |
| Duration of Response (DOR) | Up to 2 years |
Countries
Canada, United States
Outcome results
None listed