Not Yet RecruitingPhase 2/3

A Phase II/III Study of Linperlisib Plus CHOP Versus CHOP in Patients With Newly Diagnosed Peripheral T Cell Lymphoma

606 participantsStarted 2024-09-10

Plain-language summary

This is a Phase II/III, international multiple center study to evaluate the efficacy, safety, and PK of Linperlisib plus CHOP and CHOP in adult patients with Newly Diagnosed Peripheral T Cell Lymphoma.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS)
✓. Angioimmunoblastic T-cell lymphomas (AITL)
✓. Anaplastic large cell lymphoma (ALCL). ALK positive or ALK negative
✓. Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL).
✓. Follicular T-cell Lymphoma (FTCL). 3. Newly diagnosed and has no received systemic therapy for PTCL. 4. Has a life expectancy ≥6 months. 5. For patients with CD30+ PTCL, progressed on or are ineligible or intolerant to brentuximab vedotin, or progressed on or are ineligible or intolerant to regional standard of care if brentuximab vedotin not approved or not available.

Exclusion criteria

✕. Has received anti-lymphoma therapy.
✕. Patients with extranodal NK/T-cell lymphoma or CTCL.
✕. Has dropsy of serous cavity not under controlled by surgical drains or other therapy.
✕. Patients with peripheral T-cell lymphoma having known central nervous system (CNS) invasion (either CNS lymphoma or leptomeningeal lymphoma).
✕. Has received systemic steroids (in dosing exceeding 20 mg daily of prednisone equivalent) within 14 days of the first dose of study treatment.
✕. Presence of multiple factors affecting drug administration and absorption such as inability to swallow, diarrhea of CTCAE Grade \>1, and ileus. Use of any drug that may result in QT prolongation (e.g., antiarrhythmic agents) cannot be interrupted during the study.
✕. Has a history of or concurrent interstitial lung disease of any severity and/or severely impaired lung function.
✕. Has active viral, bacterial, fungal infection or other serious infection requiring systemic treatment within 14 days before the first dose of study treatment. Routine antimicrobial prophylaxis is permitted.

What they're measuring

Overall response rate

Timeframe: Study treatment will continue until unacceptable toxicity or documented disease progression, or for 2 years, whichever is earlier.

progression-free survival

Timeframe: Study treatment will continue until unacceptable toxicity or documented disease progression, or for 2 years, whichever is earlier.

Trial details

NCT IDNCT06548347

SponsorShanghai YingLi Pharmaceutical Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Peripheral T Cell Lymphoma trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS)
✓. Angioimmunoblastic T-cell lymphomas (AITL)
✓. Anaplastic large cell lymphoma (ALCL). ALK positive or ALK negative
✓. Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL).
✓. Follicular T-cell Lymphoma (FTCL). 3. Newly diagnosed and has no received systemic therapy for PTCL. 4. Has a life expectancy ≥6 months. 5. For patients with CD30+ PTCL, progressed on or are ineligible or intolerant to brentuximab vedotin, or progressed on or are ineligible or intolerant to regional standard of care if brentuximab vedotin not approved or not available.

Exclusion criteria

✕. Has received anti-lymphoma therapy.
✕. Patients with extranodal NK/T-cell lymphoma or CTCL.
✕. Has dropsy of serous cavity not under controlled by surgical drains or other therapy.
✕. Patients with peripheral T-cell lymphoma having known central nervous system (CNS) invasion (either CNS lymphoma or leptomeningeal lymphoma).
✕. Has received systemic steroids (in dosing exceeding 20 mg daily of prednisone equivalent) within 14 days of the first dose of study treatment.
✕. Presence of multiple factors affecting drug administration and absorption such as inability to swallow, diarrhea of CTCAE Grade \>1, and ileus. Use of any drug that may result in QT prolongation (e.g., antiarrhythmic agents) cannot be interrupted during the study.
✕. Has a history of or concurrent interstitial lung disease of any severity and/or severely impaired lung function.
✕. Has active viral, bacterial, fungal infection or other serious infection requiring systemic treatment within 14 days before the first dose of study treatment. Routine antimicrobial prophylaxis is permitted.

What they're measuring

Overall response rate

Timeframe: Study treatment will continue until unacceptable toxicity or documented disease progression, or for 2 years, whichever is earlier.

progression-free survival

Timeframe: Study treatment will continue until unacceptable toxicity or documented disease progression, or for 2 years, whichever is earlier.