New combination therapy for 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

This study is testing a new combination treatment for people with untreated angioimmunoblastic T-cell lymphoma to see if it helps them respond better to therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT05958719 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with histologically confirmed nodal T-follicular helper cell lymphoma and proper organ function.

Not a fit: Patients who have previously received any form of chemotherapy or have central nervous system involvement by lymphoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a more effective treatment option for patients with nodal TFH cell lymphoma, potentially improving response rates and outcomes.

How similar studies have performed: While this approach is novel, similar combination therapies have shown promise in treating other types of lymphomas, suggesting potential for success.

Eligibility criteria

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 this trial is running

Tianjin, Tianjin Municipality

• 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.

Conditions Peripheral T Cell Lymphoma; Epigenetic Repression