Phase Ⅱ Study of Chidamide in Combination With CHOP in Previously Untreated Peripheral T-Cell Lym… (NCT05572983) | Clinical Trial Compass
RecruitingPhase 2
Phase Ⅱ Study of Chidamide in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype
China47 participantsStarted 2022-09-01
Plain-language summary
This is a prospective, open-label, single arm, multicenter clinical study to evaluate the safety, tolerability, efficacy of chidamide in combination with CHOP in previously untreated peripheral T-cell lymphoma with follicular helper of T cell phenotype
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 old and ≤75 years old, male and female;
. Peripheral T-Cell lymphoma with follicular helper of T cell phenotype confirmed by histopathology at the study center, including: ① Angioimmunoblastic T-cell lymphoma (AITL), ②follicular T-cell lymphoma (FTCL), and ③ other nodal PTCL with TFH phenotype;
. Never received chemotherapy, radiotherapy, immunological and biological therapy for lymphoma before;
. Autologous stem cell transplantation is not suitable or the patient refused to accept autologous stem cell transplantation;
. There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma: measurable lesion: Positron emission tomography / computed tomography (PET/CT) or CT and/or MRI, intranode lesions with long diameter \>1.5cm, short diameter \>1.0cm, or exnode lesions with long diameter \> 1.0 cm; PET CT examination of the lesion showing increased uptake in lymph nodes or extranodal areas (higher than liver) and imaging features consistent with lymphoma can be evaluated.
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.
. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2；
. Expected survival ≥ 3 months;
. The following required baseline laboratory data:
Exclusion criteria
. A history of other malignant tumors within the past 5 years; Or other tumors (except basal cell carcinoma of the skin)
. Patients with significant vital organ dysfunction;
. Patients with active bleeding or newly developed thrombotic disease, and patients who are taking anticoagulants and having a bleeding tendency;
. Patients with a known history of Human Immunodeficiency Virus (HIV) infection and/or acquired Immunodeficiency syndrome;
. Patients with active chronic hepatitis B or active hepatitis C. Patients who are hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or hepatitis C virus (HCV) antibody positive during the screening period require further testing for Hepatitis B Virus (HBV) DNA and HCV RNA. If HBV DNA is no more than 2500 copies /mL or 500 IU/mL and HCV RNA is no more than the lower limit of the assay, enrollment will be allowed after exclusion of treatment-requiring active hepatitis B or C infection. Hepatitis B virus carriers, stable hepatitis B (no more than 2500 copies /mL or 500 IU/mL of DNA) and cured hepatitis C patients were eligible;
. Subjects who were treated with systemic glucocorticoids or other immunosuppressive agents for a condition within 14 days prior to initiation of study treatment {Local, ocular, intra-articular, intranasal, and inhaled glucocorticoids were allowed (with very low systemic absorption); Short-term (≤ 7 days) use of glucocorticoids for prophylactic treatment (e.g., contrast media allergy) or for treatment of non-autoimmune conditions (e.g., delayed hypersensitivity due to contact allergens) is allowed;
. With active, and in the past two years need systemic treatment of autoimmune diseases (hormone replacement therapy is not considered a systemic treatment, such as type 1 diabetes, hypothyroidism only requiring thyroid hormone replacement therapy, low adrenocortical or pituitary function only requiring physiological doses of sugar cortical hormone replacement therapy ); Patients with autoimmune diseases that have not required systemic treatment in the past two years are eligible;
. Patients with unstable angina and/or congestive heart failure or vascular disease (such as, the aortic aneurysm or peripheral venous thrombosis requiring surgery to repair) requiring hospital treatment within 12 months. Patients with other cardiac damage (such as poor control of arrhythmia, myocardial infarction, or ischemic) which may affect the drug safety evaluation within 12 months;