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Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
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 Patients with stable or progressive disease after 4 cycles are withdrawn.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.
Official title: Evaluation of Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for Reviously Untreated Nodal T-follicular Helper (TFH) Cell Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
37
Start Date
2023-03-02
Completion Date
2027-03-02
Last Updated
2024-12-30
Healthy Volunteers
No
Interventions
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.
Locations (1)
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China