Actively Recruiting
Evaluation of Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for Previously Untreated Nodal T-follicular Helper (TFH) Cell Lymphoma
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2024-12-30
37
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new combination therapy called CAMP, which includes chidamide, azacitidine, liposomal mitoxantrone, and prednisone, for people with previously untreated angioimmunoblastic T-cell lymphoma (AITL). This single-arm study aims to assess the objective response rate (ORR) and safety of CAMP compared to standard treatments. The study treats younger patients (aged 70 or below) with the full CAMP regimen, while older patients receive a modified CAMP-light version. PET-CT scans after 4 cycles help determine treatment response using the Deauville 5-point scale. Participants receive four cycles of the CAMP regimen, followed by an interim PET-CT scan to evaluate their response. Those with a complete response (CR) or partial response (PR) continue with consolidation therapy and then move on to maintenance therapy with chidamide taken orally for 24 months. Patients achieving CR may undergo autologous stem cell transplantation (ASCT), while those with PR receive two additional consolidation cycles before another PET-CT scan and possible transplantation. Participants with stable or progressive disease at the interim assessment are withdrawn from the study. Throughout the study, participants undergo various assessments, including PET-CT imaging to monitor disease status. Researchers measure outcomes such as ORR and treatment-related adverse events over two years. Secondary outcomes include progression-free survival, duration of response, and overall survival. The study monitors participants closely for disease progression, with discontinuation if progression occurs at any time. The total participation duration includes treatment, consolidation, maintenance, and follow-up periods.
CONDITIONS
Brief 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 1.0 x 10^9/L, platelet count 75 x 10^9/L, total bilirubin 1.5 times upper limit of 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% measured 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 severe illnesses
- Pregnant or breastfeeding women
- Infection with human immunodeficiency virus (HIV)
- History of other malignant tumors unless cured for 5 years or more, 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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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants receive the CAMP regimen consisting of chidamide, azacitidine, liposomal mitoxantrone, and prednisone for four 21-day cycles. After the fourth cycle, an interim PET-CT scan assesses response to therapy.
4 treatment cycles with visits every 3 weeks
Duration - Up to 6 weeks
Participants who achieve a complete response continue with either autologous stem cell transplantation (ASCT) or 2 additional cycles of the CAMP regimen. Participants with a partial response receive 2 more cycles of CAMP regimen followed by a second PET-CT scan before ASCT. Participants with stable or progressive disease withdraw from the study.
2 treatment cycles with visits every 3 weeks plus PET-CT scan
Duration - Up to 24 months
Participants who complete consolidation enter maintenance therapy with single-agent chidamide taken orally twice weekly for up to 24 months.
Regular follow-up visits during maintenance therapy
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.
H
Huimin Liu, Dr.
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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