Peripheral T-cell lymphomas (PTCLs) are a heterogeneous group of rare disorders that result from clonal proliferation of mature post-thymic lymphocytes. These T-cell neoplasms account for approximately 10-15% of all lymphomas. The most common subtype of PTCL is classified as "not otherwise specified" (NOS) which accounts for 30-40%.
PTCLs have been treated similarly with CHOP (Cyclophosphamide, Hydroxydaunorubicin, Vincristine and Prednisone), often with etoposide (CHOEP), followed by high-dose therapy and autologous stem cell transplantation (ASCT) in first remission. However, \<50% of the patients are cured with CHOP alone, and the progression-free survival rates at 5 years are as low as 20% for PTCLs. Meanwhile, for elderly patients who can't endure CHOPE and proceed ASCT, the long-term survival is even worse.
Aclarubicin is an anthracycline which showed good safety profile in the treatment of both myeloid and lymphocytic leukemia. 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.
The purpose of this study is to determine the efficacy of Aclarubicin, Cyclophosphamide, Vincristine, and Prednisone (CAOP) in elderly patients with newly diagnosed PTCLs. The investigators hope to try to replace doxorubicin in CHOP with aclarubicin, which is less toxic, without reducing the efficacy of patients while ensuring safety.
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Age ≥ 65 years at enrollment
ECOG performance status score ≤ 2
Able to comply with the research visit plan and other protocol requirements
Mental illness, disability, or social circumstances that may affect participant safety, ability to provide informed consent, or poor adherence
Other types of lymphoma
Previous immunotherapy or chemotherapy for PTCL, excluding those who used corticosteroids (≤8 days) prior to enrollment
Previous radiotherapy for PTCL, excluding those confined to a single lymph node region
Single group
Aclarubicin
Drug20mg/m\^2/D, D1-4, QD, ivgtt
Cyclophosphamide
Drug750 mg/m\^2, D1, ivgtt
Vincristine
Drug1.4 mg/m\^2, D1 (maximum 2mg/d), IV
Prednisone
Drug60 mg/m\^2, D1-5 (maximum 100mg/d), Po
Complete remission rate (CR)
Proportion of enrolled subjects who achieved CR after receiving up to 6 cycles of the CAOP regimen
Progression Free Survival
The time from enrollment to confirmed disease progression or death from any cause.
Overall Survival
The time from enrollment to death from any cause.
Adverse Events
Adverse Events (CTCAE v6.0), Vital Signs and Physical Examination, ECOG, Clinical Laboratory Tests, Electrocardiogram (ECG), Echocardiography, Cardiac Enzyme Profile
Change in quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) global health status score
Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The global health status score ranges from 0 to 100, with higher scores indicating better quality of life. Scores will be calculated according to the EORTC scoring manual and summarized as change from baseline.
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Shanghai Jiao Tong University School of Medicine
Lead sponsor
Leiden University Medical Center
Collaborator
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