An Open-label, Single-arm, Multicenter Phase II Clinical Study of Azacitidine, Chidamide Combined… (NCT07598578) | Clinical Trial Compass
RecruitingEarly Phase 1
An Open-label, Single-arm, Multicenter Phase II Clinical Study of Azacitidine, Chidamide Combined With PD-1 Monoclonal Antibody in the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma.
China30 participantsStarted 2026-06-01
Plain-language summary
An Open-Label, Single-Arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy of Azacitidine, Chidamide, and PD-1 Monoclonal Antibody in the Treatment of Refractory/Relapsed Peripheral T-Cell Lymphoma.
Who can participate
Age range
18 Years – 75 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
. Age ≥18 years and ≤75 years, male or female.
. Histologically confirmed peripheral T-cell lymphoma (PTCL) by the investigating center, including: peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS); anaplastic large cell lymphoma (ALK-negative or ALK-positive); angioimmunoblastic T-cell lymphoma; enteropathy-associated T-cell lymphoma; NK/T-cell lymphoma; and other PTCL subtypes deemed eligible by the investigator.
. Relapsed or refractory disease after at least one prior line of systemic therapy. Relapse is defined as disease recurrence after complete response (CR) or progression after partial response (PR) or stable disease (SD). Refractory disease is defined as progressive disease (PD) after 2 cycles of therapy, or SD after 4 cycles of therapy, or failure to achieve response after adequate last-line therapy (e.g., at least 2-3 cycles of systemic chemotherapy without remission), or progression during treatment.
. Patients considered ineligible for autologous hematopoietic stem cell transplantation by the investigator, or those who refuse such treatment.
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
Objective Response Rate (ORR)
Timeframe: From first dose of study drug until disease progression, initiation of new anti-cancer therapy, or study completion (up to 24 months).
2
Complete Response Rate (CRR)
Timeframe: From first dose of study drug until disease progression, initiation of new anti-cancer therapy, or study completion (up to 24 months).
Trial details
NCT IDNCT07598578
SponsorSecond Affiliated Hospital of Soochow University
. At least one measurable or evaluable lesion according to the Lugano 2014 classification. Measurable lesion: nodal lesion with longest diameter \>1.5 cm and shortest diameter \>1.0 cm on CT/PET-CT or MRI; or extranodal lesion with longest diameter \>1.0 cm. Evaluable lesion: nodal or extranodal focal uptake on 18F-FDG/PET higher than liver with PET and/or CT features consistent with lymphoma.
. ECOG performance status 0-2.
. Life expectancy ≥3 months.
. Adequate organ and bone marrow function defined as:
Exclusion criteria
. History of other malignancies within the past 5 years, except for those treated with curative intent (e.g., basal cell carcinoma of the skin, carcinoma in situ).
. Patients with significant dysfunction of major organs.
. Known involvement of central nervous system (CNS) lymphoma.
. History of active bleeding or newly diagnosed thrombotic disease, or those with bleeding tendency receiving anticoagulant therapy.
. Known history of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
. Patients with active chronic hepatitis B or active hepatitis C.
. Systemic corticosteroid therapy or other immunosuppressive therapy required for any condition within 14 days prior to initiation of study treatment.
. Active autoimmune disease requiring systemic treatment within the past two years. Patients with autoimmune diseases not requiring systemic treatment in the past two years may be enrolled.