CMOP Regimen and Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (NCT05896813) | Clinical Trial Compass
UnknownNot Applicable
CMOP Regimen and Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma
China30 participantsStarted 2023-03-01
Plain-language summary
Peripheral T-cell lymphoma (PTCL) is a highly heterogeneous and aggressive non-Hodgkin's lymphoma. The incidence rate of PTCL in China is much higher than the global average, and there is no unified standard treatment for initial PTCL. Currently, the CHOP regimen is widely used as first-line treatment. However, the overall response rate is still low, and effective therapies need to be explored. Epigenetics and genetics jointly determine critical features of tumors, and exploring new treatment strategies and developing targeted drugs based on deep understanding of the pathogenesis is of significant importance. The combined application of DNMT inhibitors and HDAC inhibitors has strong scientific support. The Phase II clinical study of Mitoxantrone Hydrochloride Liposome in treating relapsed or refractory PTCL achieved positive results and regulatory approval. The CMOP regimen combining Mitoxantrone Hydrochloride Liposome with Chidamide is worth exploring for initial PTCL treatment.
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 patient understands the content of this study, voluntarily participates in the study, and signs the informed consent form (ICF);
. Age: 18-80 years;
. Expected survival time ≥ 3 months;
. Histologically confirmed PTCL, one of the following subtypes:
. PTCL not otherwise specified (PTCL-NOS)
. Nodal T follicular helper (Tfh) cell lymphoma
. Other subtypes of PTCL that the researcher deems eligible for inclusion in the study;
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
ORR
Timeframe: 1 year
Trial details
NCT IDNCT05896813
SponsorThe First Affiliated Hospital with Nanjing Medical University
. At least one measurable or evaluable lesion that meets the Lugano2014 criteria: for lymph node lesions, the longest diameter should be \>1.5 cm, and for extranodal lesions, the longest diameter should be \>1.0 cm;
Exclusion criteria
. Long QT syndrome or QTc interval \>480 ms;
. Complete left bundle branch block, II or III degree atrioventricular block;
. Left ventricular ejection fraction (LVEF) \<50%;
. A history of acute myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or other arrhythmias or clinically significant pericardial disease requiring treatment within the six months prior to recruitment or evidence of acute ischemic or active conduction system abnormalities on the electrocardiogram; 4. Active hepatitis B or C infection (hepatitis B surface antigen positive and hepatitis B virus DNA \> 1x104 copies/mL; hepatitis C virus RNA \> 1x104 copies/mL); 5. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 6. Previously or currently diagnosed with other malignant tumors (except for non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have not been treated and effectively controlled within the past five years); 7. Central nervous system (CNS) lymphoma or a history of CNS lymphoma; 8. Pregnant or lactating women and childbearing patients who do not want to take contraceptive measures; 9. Other situations judged by the researcher to be unsuitable for participation in this study.