RecruitingPhase 2NCT05958719

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

Evaluation of Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for Reviously Untreated Nodal T-follicular Helper (TFH) Cell Lymphoma

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

37 participants

Start Date

Mar 2, 2023

Study Type

INTERVENTIONAL

Conditions

Peripheral T Cell Lymphoma Epigenetic Repression

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 Patients with stable or progressive disease after 4 cycles are withdrawn.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

Min Age: 18 Years

Inclusion Criteria6

Subjects must have histological confirmation of nodal T-follicular helper (TFH) cell lymphoma.
More than 18 years of age.
Proper functioning of the major organs: 1) The absolute value of neutrophils (≥1×10\^9/L); 2) platelet count (≥75×10\^9/L); 3) Serum total bilirubin ≤ 1.5 times ULN; 4) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN; 5) Serum creatinine (Cr) ≤2 ULN, or glomerular filtration rate ≥40ml/min;
Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
LVEF value measured by echocardiography ≥50%.
Life expectancy \> 3 months.

Exclusion Criteria8

Patients who have previously received chemotherapy, radiotherapy or other antitumor therapy.
Patients with central nervous system involvement by lymphoma.
Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases.
Pregnant or breastfeeding women.
Presence of human immunodeficiency virus (HIV) virus infection.
Previous history of other malignant tumors, unless the disease has been cured for 5 years or more. The following cured tumors are excluded:
Basal cell carcinoma of the skin, squamous cell carcinoma of the skin and related localized non-melanoma skin cancers;
Carcinoma in situ of the cervix