Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma
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 Patients with stable or progressive disease after 4 cycles are withdrawn.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.
Timeline
- Start
- 2023-03-02
- Primary completion
- 2026-12-30
- Completion
- 2027-03-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tucidinostat | Small molecule | 20 mg | Oral |
| Subject | Tucidinostat | Small molecule | 30 mg | Oral |
| Background | Azacitidine | Other / unclassified | 75 mg/m2 | — |
| Background | Mitoxantrone | Small molecule | 12 mg/m2 | — |
| Background | Prednisone | Other / unclassified | 60 mg/m2 | — |