NCT07168317 Tislelizumab , Cyclophosphamide, Mitoxantrone Liposomes, Chidamide, and Prednisone in the Treatment of New Diagnosed AITL
| NCT ID | NCT07168317 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The Affiliated Hospital of Xuzhou Medical University |
| Condition | New Diagnosed Angioimmunoblastic T-Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2028-08-01 |
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 40 participants in total. It began in 2025-08-01 with a primary completion date of 2028-08-01.
⚠ 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
Angioimmunoblastic T-cell lymphoma (AITL) is a rare and aggressive lymphoma. At present, the treatment of new diagnosed AITL has limited efficacy and a high recurrence rate. The study seeks to explore the possibility of improving the efficacy of immunotherapy and chemotherapy and epigenetically regulated drugs.
Eligibility Criteria
Inclusion Criteria: * Pathological diagnosis of AITL according to WHO classification in 2016, and pathological diagnosis of AITL according to WHO classification in 2016, and at least one evaluable or measurable lesion meeting Lugano2014 criteria: lymph node lesion, detectable lymph node length\>1.5cm; non-lymph node lesion, detectable extra-nodal lesion length\>1.0cm; * Never received systemic or local treatment including chemotherapy before; * Age ≥18 years old, male or female, ECOGPS≤3 points; * Life expectancy exceeds 3 months; * Follow-up conditions. Patients understand the characteristics of the disease and voluntarily join the study protocol for treatment and follow-up. Exclusion Criteria: * Subjects who meet any of the following criteria are not eligible for inclusion in this study: * Patients with abnormal liver and kidney function, specifically serum direct bilirubin, serum indirect bilirubin and/or alanine aminotransferase, aspartate aminotransferase and serum creatinine\>2 times normal values, unless abnormal liver and kidney function is considered to be related to lymphoma; * Bone marrow failure, specifically defined as absolute neutrophil count (ANC)\<1.5\*10\^9/L or platelets \<75\*10\^9/L or Hb\<90g/L, unless changes in hemogram are considered to be associated with lymphoma infiltration of the bone marrow; * Patients who have previously received local or systemic anti-tumor treatment; * Chronic heart failure with cardiac function class III or IV; or left ventricular ejection fraction \<50%; or patients with the following cardiac diseases within 6 months: acute coronary syndrome; acute heart failure (Class III or IV of cardiac function class); patients with a history of clinically significant QT prolongation (\>450 ms for men,\>470 ms for women), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, symptomatic coronary heart disease requiring medical treatment; * AIDS, syphilis, active B (HBV DNA\>1\*10\^4 copies/ml) and hepatitis C; * Patients with other malignancies that are not effectively controlled; or with other hematological disorders (e.g. hemophilia, myelofibrosis, etc.), the investigator considers that the patient is not suitable for enrollment; * History of autoimmune disease, receiving immunosuppressive therapy before enrollment, immunosuppressive dose\>10 mg/day or oral prednisone for more than 2 weeks; * Clinically uncontrolled active infection (including bacterial, fungal or viral infections), and drug therapy is ineffective; * Patients with uncontrolled hemophagocytic syndrome; * Patients who have received secondary surgery or above within 3 weeks before treatment; * Patients who have participated in clinical trials of other drugs within 30 days before enrollment or are participating in clinical trials of other new drugs; * Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures; * Known allergies to investigational drug components; * The investigator considers that the enrollment is not suitable.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07168317 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying New Diagnosed Angioimmunoblastic 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 NCT07168317 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 NCT07168317 currently recruiting?
Yes, NCT07168317 is actively recruiting participants. Contact the research team at sw1981726@126.com for enrollment information.
Where is the NCT07168317 trial being conducted?
This trial is being conducted at Xuzhou, China.
Who is sponsoring the NCT07168317 clinical trial?
NCT07168317 is sponsored by The Affiliated Hospital of Xuzhou Medical University. The trial plans to enroll 40 participants.