Azacitidine-CHOP for Patients With Nodal T-cell Lymphoma With T-follicular Helper Phenotype (ACANTUS)
Plain-language summary
This trial is testing a hypomethylating agent (azacitidine or decitabine) based regimen for patients with angioimmunoblastic T-cell lymphoma (AITL) or other nodal T-follicular helper (TFH) lymphomas who have been newly diagnosed and have not yet received treatment as well as those whose disease has come back or stopped responding to prior treatment. This is a Phase 1/2 trial, which means researchers are determining the best dose and getting early information about effectiveness. This trial does not currently have sites in the United States. The trial is currently recruiting patients.
Who can join (key eligibility)
- Age 20 Years to 85 Years years
- Newly diagnosed, not yet treated
- Must be well enough for treatment (adequate performance status)
Final eligibility is determined by the trial team. This list is a starting point only.
What's being tested
ACHOP (DRUG): 1. Phase I Azacitidine D-2\~D1, starting from dose level 1. Based on the BOIN design described above, if no DLT is identified in level 1, the dose will be escalated stepwise to levels 2, 3, and then 4. Azacitidine combined with CHOP regimen every 3 weeks as below: * Level 1 - Azacitidine 50mg/m2 D-2, -1, 1 * Level 2 - Azacitidine 75mg/m2 D-2, -1, 1 * Level 3 - Azacitidine 100mg/m2 D-2, -1, 1 * Level 4 - Azacitidine 125mg/m2 D-2, -1, 1 Azacitidine at each level will be combined with the corresponding CHOP regimen as follows: * Cyclophosphamide 750mg/m2 d1 * Doxorubicin 50 mg/m2 d1 * Vincristine 1.4 mg/m2 (Max: 2 mg) d1 * Prednisolone 100mg PO d1-5 2. Phase II * Azacitidine determined dose daily for D-2, -1, 1 * CHOP (Cyclophosphamide 750mg/m2 d1, Doxorubicin 50 mg/m2 d1, Vincristine 1.4 mg/m2 (Max: 2 mg) d1, Prednisolone 100mg PO d1-5), 6 cycles in total
ACHOP
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details