drugset / Trial / NCT05230680

Azacitidine-CHOP for Patients With Nodal T-cell Lymphoma With T-follicular Helper Phenotype (ACANTUS)

NCT05230680

Phase 1/2 Recruiting 41 enrolled Won Seog Kim
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2022-07-01
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 50 mg/m2 Intravenous
Subject Azacitidine Other / unclassified 75 mg/m2 Intravenous
Subject Azacitidine Other / unclassified 100 mg/m2 Intravenous
Subject Azacitidine Other / unclassified 125 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 750 mg/m2
Background Doxorubicin Other / unclassified 50 mg/m2
Background Prednisolone Other / unclassified 100 mg Oral
Background Vincristine Small molecule 1.4 mg/m2