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OncoMatch/Clinical Trials/NCT06421948

Linperlisib Combined With Chidamide in Patients With PTCL

Is NCT06421948 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including Linperlisib and chidamide and Linperlisib and chidamide for peripheral t-cell lymphoma.

Phase 1/2RecruitingYanyan LiuNCT06421948Data as of Jun 2026Location: China

Treatment: Linperlisib and chidamide · Linperlisib and chidamide · Linperlisib and chidamide · cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisoneThe phase Ib part of this study aims to determine the recommended phase II dose (RP2D)of linperlisib in combination with chidamide for the treatment of peripheral T-cell lymphoma (PTCL). The phase IIa part is designed to evaluate the preliminary efficacy and safety of the linperlisib plus chidamide regimen in newly diagnosed PTCL patients. The phase IIb part compares the efficacy and safety of linperlisib combined with chidamide versus the standard CHOP (CHOP-like) regimen in newly diagnosed PTCL patients.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone

Other

Linperlisib and chidamideLinperlisib and chidamideLinperlisib and chidamide

Cancer type

Non-Hodgkin Lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≤ 80

Prior therapy

Cannot have received: PI3K inhibitor

Patients previously treated with PI3K inhibitor

Cannot have received: chidamide (chidamide)

Exception: phase Ib study is not limited by this item

Patients previously treated with chidamide (phase Ib study is not limited by this item)

Lab requirements

Blood counts

Hemoglobin ≥ 8 g/dL (≥5 mmol/l); Platelets ≥ 75 x 10E9/L; Absolute neutrophil count ≥ 1.0 x 10E9/L; Platelets ≥ 50 x 10E9/L permitted if documented bone marrow involvement

Kidney function

Serum creatinine ≤ 1.5 x ULN

Liver function

Serum bilirubin ≤ 1.5 x ULN; AST and/or ALT ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma

Cardiac function

left ventricular ejection fraction (LVEF) ≥ 50%

Hemoglobin ≥ 8 g/dL (≥5 mmol/l); Platelets ≥ 75 x 10E9/L; Absolute neutrophil count ≥ 1.0 x 10E9/L; Platelets ≥ 50 x 10E9/L permitted if documented bone marrow involvement; Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); Serum glutamic-oxaloacetic transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma; Serum creatinine ≤ 1.5 x ULN; left ventricular ejection fraction (LVEF) ≥ 50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06421948 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior PI3K inhibitor, chidamide disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 80 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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