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Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma

StatusActive, Not Recruiting
PhasePhase 1/2
Started2023-08-15
View on ClinicalTrials.gov ↗

Amendment history

2026-09-17
Enrollment closed, study ongoing
Final enrollment: 44 participants (planned 50)
Completion pushed: 2026-12 → 2028-12
2024-05-16
Study Status, Study Design, Eligibility v2
Enrollment target48→50
Eligibility criteria+151 characters
Inclusion Criteria: Histologically confirmed PTCL, including ALK positive anaplastic large cell lymphoma (ALCL) with an IPI score of ≥ 2, ALK negative ALCL, peripheral T-cell lymphoma non-specific type (PTCL NOS), an [...] y related T-cell lymphoma and liver spleen T-cell lymphoma; PTCL patients with CD30 expression<10%, or PTCL patients with CD30 expression ≥ 10% who are unable to receive BV treatment; Has not received anti-tumor treatment in the past; There ismust be at least one evaluable lesion/measurable lesion: the longest diameter (LDi) of the lymph node lesion is greater than 1.5 cm, or the L [...] [...]
2023-11-26
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-08→confirmed 2023-08-15
Study sites0→1
2023-07-10
Original filing
This phase Ib/II, single arm, open label, multicenter study is conducted to evaluate the efficacy and safety of linperlisib in combination with CHOP for newly diagnosed PTCL patients, and explore the reasonable dosage of linperlisib when combined with CHOP regimen.
Trial Details
NCT Number NCT05949944
Lead Sponsor Sun Yat-sen University
Conditions Peripheral T-cell Lymphoma
Enrollment 44 participants
Start Date 2023-08-15
Primary Completion 2026-09 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-16