Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05230680
PHASE1/PHASE2

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

Sponsor: Won Seog Kim

View on ClinicalTrials.gov

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

Official title: Multicenter, Open Label, Phase I/II of Azacitidine-CHOP for Patients With Nodal T-cell Lymphoma With T-follicular Helper Phenotype

Key Details

Gender

All

Age Range

20 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

41

Start Date

2022-07-01

Completion Date

2026-12-31

Last Updated

2023-10-23

Healthy Volunteers

No

Conditions

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

Locations (1)

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

Seoul, South Korea