Clinical trial · Interventional
Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for the Treatment of Previously 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 Patients with stable or progressive disease after 4 cycles are withdrawn.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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epigenetic Repression | — | UNRESOLVED | — |
| Peripheral T Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Chidamide | Drug | — | UNRESOLVED |
| liposomal mitoxantrone | Drug | — | UNRESOLVED |
| prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- interim evaluation of CR group
- description
- Untreated patients with TFH-derived peripheral T-cell lymphoma will be treated with chidamide, azacitidine, liposomal mitoxantrone, and prednisone (CAMP regimen) for four cycles. For patients with interim-PET evaluation of CR, consolidation therapy with ASCT or another two cycles with CAMP regimen can be obtained. Subsequently,chidamide monotherapy was given as maintenance therapy for 24 months. Patients with interim evaluation of SD or PD withdrew from this study.
- interventionNames
- Drug: Chidamide
- Drug: Azacitidine
- Drug: liposomal mitoxantrone
- Drug: prednisone
- type
- EXPERIMENTAL
- label
- interim evaluation of PR group
- description
- Untreated patients with TFH-derived peripheral T-cell lymphoma will be treated withchidamide, azacitidine, liposomal mitoxantrone, and prednisone (CAMP regimen) for four cycles. For patients with interim-PET evaluation of PR, another two cycles of CAMP regimen will be continued, followed by the second PET-CT efficacy evaluation, and those who achieve CR receive consolidation therapy with ASCT and following chidamide maintenance. Subsequently, chidamide monotherapy was given as maintenance therapy for 24 months. Patients with second efficacy evaluation of PR or SD or PD withdrew from this study.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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