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

Condition(s) studied

Investigational drug(s) / intervention(s)

Chidamide: chidamide 30mg biw, p.o, 21 days for a cycle.

Azacitidine: 75mg/m2, continuous i.h. on day 1-7，21 days for a cycle.

liposomal mitoxantrone: 12mg/m2， d1,21 days for a cycle.

prednisone: 60mg/m2，d1-5,21 days for a cycle.

Study summary

This study is investigating the effectiveness (specifically the objective response rate - ORR) of a new combination therapy called CAMP (chidamide, azacitidine, liposomal mitoxantrone, and prednisone) for previously untreated angioimmunoblastic T-cell lymphoma (AITL). It's a single-arm study comparing CAMP's safety and efficacy to standard treatments. Younger patients (≤70) receive the full CAMP regimen, while older patients receive a modified version (CAMP-light). Patients are assessed via PET-CT after 4 cycles. Responders (CR/PR) receive consolidation therapy and then maintenance chidamide for 2 years. Eligible patients achieving CR after 4 cycles can get a transplant, while those with PR need 2 more cycles first. Patients with stable or progressive disease after 4 cycles are withdrawn. Progression at any time leads to study discontinuation.

Eligibility

Primary outcome measure(s)

• Objective Response Rate (ORR) — 2 years post initiation of treatment
  ORR is defined as the incidence of either a CR or a partial response (PR) per the Lugano Classification by PET-CT as determined by study investigators.
• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 — 2 years post initiation of treatment

Trial sites (1)

On this site

More Institute of Hematology & Blood Diseases Hospital, China trials in China

Other trials for the same condition