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New treatment option for Peripheral T-cell Lymphoma
Official title Linperlisib Combined With Chidamide in Patients With PTCL
ClinicalTrials.gov ID: NCT06421948
What this study is testing
What is Linperlisib and chidamide?
Linperlisib and chidamide is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for peripheral t-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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)...
- ECOG PS 0-2 at protocol entry
- Estimated life expectancy of 6 months or longer
- Measurable disease
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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...
- Written informed consent
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China; Wuhan, Hubei, China; Changsha, Hunan, China; Chengdu, Sichuan, China; Tianjin, Tianjin Municipality, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.