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New treatment option for Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype
Official title Phase Ⅱ Study of Chidamide in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype
ClinicalTrials.gov ID: NCT05572983
What this study is testing
What is Chidamide combined with CHOP?
Chidamide combined with CHOP is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for peripheral t-cell lymphoma with follicular helper of t cell phenotype.
Also referred to as Induction treatment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- people who were treated with systemic glucocorticoids or other immunosuppressive agents for a condition within 14 days prior to initiation of study...
See the full eligibility 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...
- 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...
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2；
- Expected survival ≥ 3 months;
- The following required baseline laboratory data:
- .White blood cell，WBC≥3.0×109/L(Bone marrow invasive patient≥2.0×109/L), Absolute neutrophil count，ANC ≥1.5×109/L, （Bone marrow invasive patient≥1.0×109/L), Platelet count (PLT) ≥75×109/L, （Bone marrow invasive...
- .Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) (The liver invasion ≤3.0×ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN（The liver invasion≤5.0×ULN）
- .Renal function：creatinine, Cr≤1.5×ULN
- .Coagulation function： International Normalized Ratio (INR)≤1.5 ×ULN； Prothrombin Time (PT)、Activated Partial Thromboplastin Time (APTT)≤1.5×ULN（Unless the patient is receiving anticoagulant therapy and PT and APTT are...
- .Thyroid stimulating hormone (TSH) or free thyroid hormone (FT4) or free triiodothyronine (FT3) were within 10% of normal value (note: abnormal TSH caused by non-autoimmune causes can be included in the group);
- people fully understand and voluntarily participate in this study and sign informed consent
- 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...
- people 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...
- 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...
- 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 who underwent major surgery within 28 days before enrollment; Less than 6 weeks after major organ surgery;
- Long-term unhealed wounds or incomplete healing fractures;
- Receive live attenuated vaccine (except influenza vaccine) within 4 weeks before enrollment or during the study period;
- Pregnant or lactating women and people of reproductive age who do not want to take contraceptive measures;
- Patients with mental illness or who cannot obtain informed consent;
- There is active infection, except for tumor-related B symptoms and fever;
- Cardiac clinical symptoms or diseases that are not well controlled, such as: I. Nyha grade 2 or above heart failure; II. Unstable angina pectoris; III. Myocardial infarction has occurred within 1 year; IV. Patients with...
- Ineligibility to participate in the study was determined by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.