Study of Chidamide Combined With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for Untreated Nodal T-follicular Helper Cell Lymphoma

What this Trial Is About

Researchers are evaluating the effectiveness of a new combination therapy called CAMP, consisting of chidamide, azacitidine, liposomal mitoxantrone, and prednisone, for patients with previously untreated angioimmunoblastic T-cell lymphoma (AITL). This phase 2 study compares the safety and response rate of CAMP to standard treatments. Patients aged 70 or younger receive the full CAMP regimen, while those older than 70 receive a modified CAMP-light version. The study aims to measure the objective response rate (ORR) and treatment safety over two years. Treatment involves cycles of chemotherapy administered every 21 days. After four cycles, patients undergo PET-CT scans to assess response. Those with complete or partial responses receive two additional consolidation cycles followed by maintenance chidamide therapy for 24 months, with dosing adjusted by age. Eligible patients achieving a complete response may proceed to stem cell transplantation, while partial responders receive further consolidation before transplant. Patients with stable or progressive disease after initial cycles discontinue the study. Participants are monitored through imaging and laboratory tests throughout the study. Researchers assess response rates and treatment-related side effects using standardized criteria over two years. Safety and effectiveness are closely followed, with treatment adjustments based on individual responses and disease progression. The total study duration includes initial treatment cycles, consolidation, maintenance therapy, and follow-up assessments.

Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma