Tislelizumab , Cyclophosphamide, Mitoxantrone Liposomes, Chidamide, and Prednisone in the Treatme⦠(NCT07168317) | Clinical Trial Compass
RecruitingPhase 2
Tislelizumab , Cyclophosphamide, Mitoxantrone Liposomes, Chidamide, and Prednisone in the Treatment of New Diagnosed AITL
China40 participantsStarted 2025-08-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 ā„18 years old, male or female, ECOGPSā¤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 ā¦
What they're measuring
1
Outcome Measure
Timeframe: Time forecasting: 24 months
Trial details
NCT IDNCT07168317
SponsorThe Affiliated Hospital of Xuzhou Medical University