Chidamide Plus Golidocitinib in Relapsed/Refractory Peripheral T-Cell Lymphoma (NCT06757387) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Chidamide Plus Golidocitinib in Relapsed/Refractory Peripheral T-Cell Lymphoma
45 participantsStarted 2024-12-30
Plain-language summary
This is a Phase I/II, open-label, single-arm study investigating the combination of chidamide and golidocitinib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The Phase I portion utilizes a 3+3 dose-escalation design to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of the drug combination. The Phase II portion will then evaluate the efficacy and safety of the RP2D in approximately 28 patients with relapsed or refractory PTCL. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or meeting other stopping criteria. The primary goal of Phase I is to establish the safety and MTD and the RP2D. The primary goal of Phase II is to evaluate the treatment efficacy and safety of the combination at RP2D.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The subject must fully understand the study, voluntarily participate, and sign an informed consent form.
* The subject must be ≥ 18 years of age and ≤ 80 years of age, of either sex.
* The subject must have a histopathologically confirmed diagnosis of peripheral T-cell lymphoma (PTCL) according to the 2016 WHO classification, including peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), NK/T-cell lymphoma, anaplastic large cell lymphoma ALK-positive (ALCL ALK+), anaplastic large cell lymphoma ALK-negative (ALCL ALK-), enteropathy-associated T-cell lymphoma, and hepatosplenic T-cell lymphoma.
* The subject must have relapsed or refractory disease following prior systemic therapy (including autologous hematopoietic stem cell transplantation). Note: The subject must have received ≥1 and ≤3 prior lines of systemic therapy. Relapsed is defined as recurrence following a CR. Refractory is defined as disease with stable disease (SD) or progressive disease (PD) during interim efficacy assessment with prior systemic chemotherapy, or failure to achieve a CR at the end of treatment and need for further therapy.
* The subject must have at least one evaluable or measurable lesion according to the Lugano 2014 criteria:Lymph node lesions: Measurable lymph nodes must have a long axis \>1.5 cm.
Non-lymph node lesions: Measurable extranodal lesions must have a long axis \>1.0 cm.
* The subject must have an Eastern Co…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
dose-limiting toxicities (DLTs)
Timeframe: within 28 days
Trial details
NCT IDNCT06757387
SponsorPeking University Cancer Hospital & Institute