NCT06433362 CMOEP in the Treatment of Untreated Peripheral T-cell Lymphoma
| NCT ID | NCT06433362 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | Peripheral T Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 115 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 115 participants in total. It began in 2024-06-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, single arm, multicenter study to evaluate the safety and efficacy of CMOEP in patients with untreated peripheral T-cell lymphoma.
Eligibility Criteria
Inclusion Criteria: * 1.Subjects fully understand and voluntarily participate in this study and sign informed consent. 2\. Age ≥18, ≤70years(for 65-70 years old, researchers need to comprehensively evaluate the physical fitness and tolerance of patients), no gender limitation. 3\. Expected survival ≥ 3 months. 4.Histologically confirmed diagnosis of Peripheral T-cell lymphoma： 1) Peripheral T-cell lymphoma unspecified (ptcl-NOS) 2) Angioimmunoblastic T-cell lymphoma (AITL) 3) Anaplastic large T-cell lymphoma (ALCL), ALK+ 4) Anaplastic large T-cell lymphoma (ALCL), ALK- 5) Other subtypes of PTCL that the investigator think can be included in the group. 5.No previous treatment for PTCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except for local radiotherapy to alleviate tumor related symptoms), surgical treatment. 6.Subjects must have at least one evaluable or measurable lesion per lugano2014 criteria: for lymph node lesions, the length and diameter should be \>1.5cm; For non-lymph node lesions, the length and diameter should be \>1.0cm. 7.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1. 8.The following baseline laboratory criteria are required: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, Platelet count (PLT) ≥75×10\^9/L, Hemoglobin(HB)≥ 90 g/L(Restriction may be relaxed in patients with bone marrow involvement, Absolute neutrophil count (ANC) ≥1.0×10\^9/L, Platelet count (PLT) ≥50×10\^9/L, Hemoglobin(HB)≥ 75g/L). 9.Total Serum creatinine (Scr) ≤1.5X upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN(For patients with liver invasion ≤5X ULN), bilirubin (TBIL)≤1.5X ULN(For patients with liver invasion ≤3X ULN ). Exclusion Criteria: * 1.Subjects with a history of prior antitumor therapy. 2.Hypersensitivity to any study drug or its components. 3.Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.) 4.Heart function and disease meet one of the following conditions:1）Long QTc syndrome or QTc interval \>480 ms;2）Complete left bundle branch block, grade II or III atrioventricular block;3）Serious and uncontrolled arrhythmias requiring drug treatment;4）New York Heart Association grade ≥ II;5）Cardiac ejection fraction (LVEF)\<50%;6）A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment. 5.Hepatitis B and hepatitis C active infection (defined as hepatitis B virus surface antigen positive and hepatitis B virus DNA higher than 1x10\^3 copy/mL; hepatitis C virus RNA high than 1x10\^3 copy/mL). 6.Human immunodeficiency virus (HIV) infection (HIV antibody positive). 7.Patients with other malignant tumors, except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ and other tumor during the past 5 years. 8.Patients with primary or secondary central nervous system (CNS) lymphoma or history of CNS lymphoma. 9.Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures. 10.Unsuitable subjects for this study determined by the investigator.
Contact & Investigator
Huilai Zhang
STUDY DIRECTOR
Department of Lymphoma, Tianjin Medical University Cancer Institute and Hospital
Frequently Asked Questions
Who can join the NCT06433362 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Peripheral T Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06433362 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06433362 currently recruiting?
Yes, NCT06433362 is actively recruiting participants. Contact the research team at jingweiyu@pku.org.cn for enrollment information.
Where is the NCT06433362 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06433362 clinical trial?
NCT06433362 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The principal investigator is Huilai Zhang at Department of Lymphoma, Tianjin Medical University Cancer Institute and Hospital. The trial plans to enroll 115 participants.