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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

July 1, 2022

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
T Cell Lymphoma
Interventions
DRUG

ACHOP

"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"

Trial Locations (1)

06351

RECRUITING

81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea, Seoul

All Listed Sponsors
lead

Won Seog Kim

OTHER