Azacitidine-CHOP for Patients With Nodal T-cell Lymphoma With T-follicular Helper Phenotyp
Induction treatment (every 3 weeks, total 6 cycles) * Azacitidine D-2, -1, 1 (level 1: 50mg/m2, level 2: 75mg/m2, level 3: 100mg/m2, level 4: 125mg/m2) * Cyclophosphamide 750mg/m2 d1 * Doxorubicin 50 mg/m2 d1 * Vincristine 1.4 mg/m2 (Max: 2 mg) d1 * Prednisolone 100mg PO d1-5 Maintenance treatment (every 4 weeks, total
| Condition(s) | T Cell Lymphoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | Induction treatment (every 3 weeks, total 6 cycles) * Azacitidine D-2, -1, 1 (level 1: 50mg/m2, level 2: 75mg/m2, level 3: 100mg/m2, level 4: 125mg/m2) * Cyclophosphamide 750mg/m2 d1 * Doxorubicin 50 mg/m2 d1 * Vincristine 1.4 mg/m2 (Max: 2 mg) d1 * Prednisolone 100mg PO d1-5 Maintenance treatment (every 4 weeks, total 12 cycles) * Azacitidine 75mg/m2 d1-5 |
| Who can participate | Inclusion Criteria: 1. Treatment-naïve patients with newly diagnosed nodal T-cell lymphoma with T-follicular helper (TFH) phenotype as determined by the following 2016 WHO diagnostic criteria: * Angioimmunoblastic T-cell lymphoma * Follicular helper T-cell lymphoma * Peripheral T-cell lymphoma with follicular helper T-cell type 2. 20 to 85 years of age at diagnosis 3. ECOG performance status 0-2 4. Cardiac function suitable for chemotherapy: LVEF ≥45% on echocardiography or MUGA 5. Appropriate renal function: Serum Cr ≤2.0mg/dL or eGFR ≥ 30mL/min according to the Cockroft-Gault formula 6. Appropriate hepatic function: ALT ≤2.5x upper limit of normal (ULN) (or ≤5x ULN in the presence of liver involvement), total bilirubin ≤2x ULN (or ≤3x ULN in the presence of liver involvement) 7. Appropri |
| Ages | 20 Years to 85 Years |
| Sex | All |
| Lead sponsor | Won Seog Kim |
| Locations | Seoul, South Korea |
| Start date | 2022-07-01 |
| NCT ID | NCT05230680 |
| Official listing | https://clinicaltrials.gov/study/NCT05230680 |