Actively Recruiting
Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2024-12-30
37
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 Patients with stable or progressive disease after 4 cycles are withdrawn.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.
CONDITIONS
Official Title
Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological confirmation of nodal T-follicular helper (TFH) cell lymphoma
- Age 18 years or older
- Proper functioning of major organs: neutrophils ≥1x10^9/L, platelets ≥75x10^9/L, total bilirubin ≤1.5 times upper limit normal (ULN), AST and ALT ≤3 times ULN, serum creatinine ≤2 ULN or glomerular filtration rate ≥40 ml/min
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Left ventricular ejection fraction (LVEF) ≥50% by echocardiography
- Life expectancy greater than 3 months
You will not qualify if you...
- Previous chemotherapy, radiotherapy, or other antitumor therapy
- Central nervous system involvement by lymphoma
- Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infections, or other significant illnesses
- Pregnant or breastfeeding women
- Human immunodeficiency virus (HIV) infection
- History of other malignant tumors unless cured for 5 years or longer, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, related localized non-melanoma skin cancers, and carcinoma in situ of the cervix
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
D
Dehui Zou, Dr.
CONTACT
H
Huimin Liu, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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