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

What this Trial Is About

Researchers are evaluating a new combination therapy called CAMP, which includes chidamide, azacitidine, liposomal mitoxantrone, and prednisone, for people with previously untreated angioimmunoblastic T-cell lymphoma AITL. This single-arm study aims to assess the objective response rate ORR and safety of CAMP compared to standard treatments. The study treats younger patients aged 70 or below with the full CAMP regimen, while older patients receive a modified CAMP-light version. PET-CT scans after 4 cycles help determine treatment response using the Deauville 5-point scale. Participants receive four cycles of the CAMP regimen, followed by an interim PET-CT scan to evaluate their response. Those with a complete response CR or partial response PR continue with consolidation therapy and then move on to maintenance therapy with chidamide taken orally for 24 months. Patients achieving CR may undergo autologous stem cell transplantation ASCT, while those with PR receive two additional consolidation cycles before another PET-CT scan and possible transplantation. Participants with stable or progressive disease at the interim assessment are withdrawn from the study. Throughout the study, participants undergo various assessments, including PET-CT imaging to monitor disease status. Researchers measure outcomes such as ORR and treatment-related adverse events over two years. Secondary outcomes include progression-free survival, duration of response, and overall survival. The study monitors participants closely for disease progression, with discontinuation if progression occurs at any time. The total participation duration includes treatment, consolidation, maintenance, and follow-up periods.

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