Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma
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 Patients with stable or progressive disease after 4 cycles are withdrawn.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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Subjects must have histological confirmation of nodal T-follicular helper (TFH) cell lymphoma.
2. More than 18 years of age.
3. 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;
4. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
5. LVEF value measured by echocardiography ≥50%.
6. Life expectancy \> 3 months.
Exclusion Criteria:
1. Patients who have previously received chemotherapy, radiotherapy or other antitumor therapy.
2. Patients with central nervous system involvement by lymphoma.
3. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases.
4. Pregnant or breastfeeding women.
5. Presence of human immunodeficiency virus (HIV) virus infection.
6. Previous history of other malignant tumors, unless the disease has been cured for 5 years or more. The following cured tumors are excluded:
1. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin and related localized non-melanoma skin cancers;
2. Carcinoma in situ of the cervix
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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