Linperlisib and Chidamide for Peripheral T-cell Lymphoma
Linperlisib Combined With Chidamide in Patients With PTCL
Recruiting
Phase 1Phase 2Interventional Study
Peripheral T-cell Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
134 (estimated)
Sponsor
Yanyan Liu · Government
Who this trial is looking for
This trial is looking for patients with newly diagnosed peripheral T-cell lymphoma. Participants will receive a combination of linperlisib and chidamide and will be monitored for safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old.
I have been diagnosed with peripheral T-cell lymphoma.
I have measurable disease.
I have a life expectancy of at least 6 months.
I have a performance status of 0-2.
I meet the blood count requirements.
I can provide written informed consent.
I am using contraception if I can become pregnant.
You may not be able to join if
I have previously been treated with a PI3K inhibitor.
I have central nervous system involvement by lymphoma.
I am positive for HIV or have active hepatitis B or C.
I have active, uncontrolled infections.
I am pregnant or breastfeeding.
I am unable to comply with the study protocol.
I am considered unfit by my doctor.
I have known allergies to the study drugs.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The 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 l…
The 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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age 18-75 years at the time of inclusion (Age 18-80 years for phase Ib and IIa study)
* Patients with a newly diagnosed and histologically confirmed PTCL (phase Ib study includes both newly diagnosed and relapsed/refractory PTCL). Anaplastic large cell lymphoma, NK/T-cell lymp…
Inclusion Criteria:
* Age 18-75 years at the time of inclusion (Age 18-80 years for phase Ib and IIa study)
* Patients with a newly diagnosed and histologically confirmed PTCL (phase Ib study includes both newly diagnosed and relapsed/refractory PTCL). Anaplastic large cell lymphoma, NK/T-cell lymphoma, and primary cutaneous T-cell lymphoma are not included.
* ECOG PS 0-2 at protocol entry
* Estimated life expectancy of 6 months or longer
* Measurable disease
* 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 ULNb; left ventricular ejection fraction (LVEF) ≥ 50%
* Women of childbearing potential must use safe anticonception (e.g. contraceptive pills, intrauterine devices etc.) during the study and 12 months after the last administration of study drugs; Male patients must use contraception for the duration of the study and 6 months after the last administration of study drugs if his partner is of childbearing potential
* Written informed consent
Exclusion Criteria:
* Patients previously treated with PI3K inhibitor
* Patients previously treated with chidamide (phase Ib study is not limited by this item)
* Suspected or documented central nervous system involvement by lymphoma
* Patients with positive HIV and/or active hepatitis B and/or hepatitis C infection
* Patients with active, uncontrolled infections
* Unwillingness or inability to comply with the protocol
* Deemed 'unfit' by the treating physician
* Pregnant and/or breastfeeding women
* Concurrent severe and/or uncontrolled medical disease which is not lymphoma-related
* Patients with contraindications to chemotherapy
* Known hypersensitivity to one or more of the study drugs
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