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Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Treated Cutaneous T-cell Lymphoma
Sponsor: Shanghai Jiao Tong University School of Medicine
Summary
Cutaneous T-cell lymphomas (CTCL) are a rare and heterogeneous group of extranidal T-cell lymphomas characterized by skin involvement. Current treatment options for CTCL are limited. Although responses have been demonstrated, their duration is often short, especially in patients with advanced stage disease. Additional treatment options are needed which demonstrate activity in cutaneous and extracutaneous sites. The traditional CHOP regimen (Cyclophosphamide, Hydroxydaunorubicin, Vincristine and Prednisone) has some efficacy for CTCL patients, but due to the cardiotoxicity of anthracyclines, patients can only receive a limited course of treatment. After stopping the regimen, most patients will experience relapse. Aclarubicin, also known as aclacinomycin A, is an anthracycline type of antibiotic with significant anti-cancer properties. Previous studies have shown that aclarubicin only induces histone eviction without causing DNA damage, and it stands out in pre-clinical models and clinical studies, as it potently kills AML cells. Meanwhile, aclarubicin lacks cardiotoxicity, and can be safely administered even after the maximum cumulative dose of either doxorubicin or idarubicin has been reached. Aclarubicin's treatment indications include malignant lymphoma, but actual clinical application experience is limited. The purpose of this study is to determine the maximum tolerated dose, safety and efficacy of aclarubicin combined with cyclophosphamide, vincristine, and prednisone (CAOP) for subjects with relapsed or refractory CTCL.
Official title: A Multicenter, Open-Label, Phase 1/2 Clinical Study of the Safety and Efficacy of Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Treated Cutaneous T-cell Lymphoma
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
37
Start Date
2026-03-30
Completion Date
2028-12-31
Last Updated
2026-04-17
Healthy Volunteers
No
Conditions
Interventions
Aclarubicin
Cycle 1-6: Phase I starting dose 20mg/m\^2/D, D1-2 (dose group 1), D1-3 (dose group 2), D1-4 (dose group 3), QD, ivgtt The Phase II dose was determined based on the Phase I results Cycle 7-10: Phase I starting dose 20mg/ m\^2/D, D1-2 (dose group 1), D1-3 (dose group 2), D1-4 (dose group 3), QD, ivgtt The Phase II dose was determined based on the Phase I results
Cyclophosphamide
Cycle 1-6 750 mg/m\^2, D1, QD, ivgtt Cycle 7-10 750 mg/m\^2, D1, QD, ivgtt
Vincristine
Cycle 1-6 1.4 mg/m\^2, D1 (maximum 2mg/d), QD, iv Cycle 7-10 1.4 mg/m\^2, D1 (maximum 2mg/d), QD, iv
Prednisone
Cycle 1-6 60 mg/m\^2, D1-5 (maximum 100mg/d), QD, Po Cycle 7-10 60 mg/m\^2, D1-5 (maximum 100mg/d), QD, Po
Locations (2)
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai
Shanghai, China
Ruijin Hospital Wuxi Branch
Wuxi, China