New combination therapy for untreated nodal TFH cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of a new combination therapy called CAMP, which includes chidamide, azacitidine, liposomal mitoxantrone, and prednisone, for patients with previously untreated angioimmunoblastic T-cell lymphoma. It employs a single-arm design where younger patients receive the full CAMP regimen, while older patients receive a modified version. The primary goal is to assess the objective response rate (ORR) after four cycles of treatment, with further consolidation and maintenance therapy for responders. Patients are monitored using PET-CT scans to evaluate treatment response.

Why it matters

Who can join: the full rules

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

Where it's running

• Institute of Hematology & Blood Diseases Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Dehui Zou, Dr. — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Dehui Zou, Dr.
• Email: zoudehui@ihcams.ac.cn
• Phone: 86-022-23909282

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.