New drug duo takes on tough lymphoma
NCT ID NCT06421948
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new combination of two targeted drugs (linperlisib and chidamide) against standard chemotherapy for people with a rare type of blood cancer called peripheral T-cell lymphoma. The goal is to see if the new combo works better at shrinking tumors and controlling the disease. About 134 adults aged 18 to 80 will take part, and the study will also check for side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 134 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated Cancer Hospital of Zhengzhou University
RECRUITINGZhengzhou, Henan, 450008, China
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Cong Li
RECRUITINGHangzhou, Zhejiang, 310000, China
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Huilai Zhang
RECRUITINGTianjin, Tianjin Municipality, 300060, China
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Liling Zhang
RECRUITINGWuhan, Hubei, 430022, China
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Ming Jiang
RECRUITINGChengdu, Sichuan, 610041, China
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Yajun Li
RECRUITINGChangsha, Hunan, 410003, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can adding linperlisib to standard chemotherapy improve outcomes in rare T-Cell lymphoma?
- Can a powerful combo of drugs and stem cell transplant beat tough lymphomas in kids?
- Can a simple blood test spot lymphoma earlier?
- Can a Five-Drug combo tame a tough lymphoma without standard chemo?
- Can a targeted pill boost Chemotherapy's punch against a rare lymphoma?
- A microchip implanted in tumors could reveal which drugs work best