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Chidamide Plus Azacitidine for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma

Chidamide Plus Azacitidine for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma

Recruiting
18 years and older
All
Phase 2

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Overview

Untreated patients with Nodal T-follicular Helper (TFH) Cell Lymphoma will be treated with chidamide combined with azacitidine for four cycles. For patients with interim evaluation of CR, consolidation therapy with ASCT or another eight cycles with chidamide combined with azacitidine can be obtained. For patients with interim evaluation of PR, another two cycles of chidamide combined with azacitidine will be continued, followed by the second efficacy evaluation, and those who achieve CR receive consolidation therapy with ASCT or another six cycles of chidamide combined with azacitidine. Subsequently, chidamide was given as maintenance therapy for 12 months. Patients with SD or PD withdrew from this study.

Eligibility

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;
  5. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
  6. LVEF value measured by echocardiography ≥50%.
  7. 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

Study details
    Peripheral T Cell Lymphoma
    Epigenetic Repression

NCT05958719

Institute of Hematology & Blood Diseases Hospital, China

28 January 2024

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