Starting soon
Phase 2
Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Untreated Peripheral T-Cell Lymphoma
Condition(s) studied
Peripheral T-Cell Lymphoma (PTCL NOS)Nodal T-follicular Helper Cell LymphomaAnaplastic Large Cell Lymphoma (ALCL) (ALK-1 Negative)
Investigational drug(s) / intervention(s)
Aclarubicin: 20mg/m\^2/D, D1-4, QD, ivgtt
Cyclophosphamide: 750 mg/m\^2, D1, ivgtt
Vincristine: 1.4 mg/m\^2, D1 (maximum 2mg/d), IV
Prednisone: 60 mg/m\^2, D1-5 (maximum 100mg/d), Po
Study summary
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.
Eligibility
Inclusion Criteria:
1. Understand and voluntarily sign the informed consent form
2. Age ≥ 65 years at enrollment
3. ECOG performance status score ≤ 2
4. Able to comply with the research visit plan and other protocol requirements
5. Patients with histologically confirmed peripheral T-cell lymphoma (PTCL) who have not previously received treatment
The following subtypes as defined by the World Health Organization (WHO) classification (2022) are eligible, with Ann Arbor stage I-IV, and pathological immunohistochemical CD30 negative:
1. Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS)
2. Nodal T-follicular helper cell lymphoma (TFH)
3. Anaplastic large cell lymphoma, ALK-negative (ALCL)
6. Life expectancy ≥ 3 months
7. Hematological, renal, and hepatic function all meet the requirements:
1. Absolute neutrophil count (ANC) ≥ 1,500/μL
2. Platelet count ≥ 100,000/μL
3. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for the institution (except for patients with Gilbert's syndrome)
4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; if liver involvement is known, then ≤ 5.0 × ULN
5. Serum creatinine ≤ 1.5 × ULN, or creatinine clearance \> 50 mL/min calculated by the Cockcroft-Gault formula
Exclusion Criteria:
1. Mental illness, disability, or social circumstances that may affect participant safety, ability to provide informed consent, or poor adherence
2. Other types of lymphoma
3. Previous immunotherapy or chemotherapy for PTCL, excluding those who used corticosteroids (≤8 days) prior to enrollment
4. Previous radiotherapy for PTCL, excluding those confined to a single lymph node region
5. Pathological immunohistochemistry showing CD30 positivity and/or ALK positivity
6. Patients planning to receive autologous or allogeneic transplantation as first-line consolidation therapy
7. Confirmed central nervous system/meningeal involvement
8. Significant uncontrolled comorbidities or infections, specifically:
1. Uncontrolled infection requiring intravenous antibiotics
2. Clinically significant heart disease (NYHA Class III or IV), unstable angina
3. History of angioplasty, stent implantation, or myocardial infarction within the past 6 months
4. Uncontrolled hypertension (systolic blood pressure \>160 mmHg) despite using two antihypertensive medications. (or diastolic blood pressure \>100 mmHg, measured twice consecutively, one week apart)
5. Clinically significant cardiac arrhythmias
6. Uncontrolled diabetes
9. Known or detected positive for human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV-1), hepatitis B, or hepatitis C.
10. Patients diagnosed with malignancy within the past two years. However, the following are excluded: non-melanoma skin cancer, melanoma in situ, localized prostate cancer (current PSA \<0.1 ng/mL), treated thyroid cancer; or cervical carcinoma in situ or breast ductal/lobular carcinoma in situ within the past two years, provided there is currently no evidence of active disease.
Primary outcome measure(s)
- Complete remission rate (CR) — After a maximum of 6 cycles of CAOP regimen (each cycle is 28 days)
Proportion of enrolled subjects who achieved CR after receiving up to 6 cycles of the CAOP regimen
Trial sites (2)
| Facility | City | Region | Status |
|---|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai |
Shanghai |
China |
|
| Ruijin Hospital Wuxi Branch |
Wuxi |
China |
|
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