Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Untreated Peripheral T-Cell Lymphoma

NCT07535762 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Acla-PTCL
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Peripheral T-Cell Lymphoma (PTCL NOS); Nodal T-follicular Helper Cell Lymphoma; Anaplastic Large Cell Lymphoma (ALCL) (ALK-1 Negative)

Keywords

PTCL; aclarubicin; elderly patients; ALCL, ALK-negative

Outcome Measures

Primary Outcomes (1)

• Complete remission rate (CR)

  Proportion of enrolled subjects who achieved CR after receiving up to 6 cycles of the CAOP regimen

  After a maximum of 6 cycles of CAOP regimen (each cycle is 28 days)

Secondary Outcomes (5)

• Progression Free Survival

  Maximum follow-up period is 2 years after the end of treatment.

• Overall Survival

  maximum follow-up period is 2 years after the end of treatment.

• Adverse Events

  From enrollment to 28 days after the end of treatment

• 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

  From enrollment to 28 days after the end of treatment

• Cancer-related fatigue as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue score

  From enrollment to 28 days after the end of treatment

Study Arms (1)

CAOP

EXPERIMENTAL

Eligible participants will receive up to 6 cycles of CAOP induction therapy (3 week cycles for 6 cycles or until progression). An interim evaluation will be conducted after 3 cycles of treatment. Efficacy will be assessed according to the 2014 Lugano criteria. If the patient achieves CR or PR, they will continue with the next 3 cycles of CAOP. If the patient does not achieve CR or PR, they will be withdrawn from the clinical trial.

Drug: Aclarubicin; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone

Interventions

Aclarubicin DRUG

20mg/m\^2/D, D1-4, QD, ivgtt

CAOP

Cyclophosphamide DRUG

750 mg/m\^2, D1, ivgtt

CAOP

Vincristine DRUG

1.4 mg/m\^2, D1 (maximum 2mg/d), IV

CAOP

Prednisone DRUG

60 mg/m\^2, D1-5 (maximum 100mg/d), Po

CAOP

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign the informed consent form
• Age ≥ 65 years at enrollment
• ECOG performance status score ≤ 2
• Able to comply with the research visit plan and other protocol requirements
• 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:
• Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS)
• Nodal T-follicular helper cell lymphoma (TFH)
• Anaplastic large cell lymphoma, ALK-negative (ALCL)
• Life expectancy ≥ 3 months
• Hematological, renal, and hepatic function all meet the requirements:
• Absolute neutrophil count (ANC) ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for the institution (except for patients with Gilbert's syndrome)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; if liver involvement is known, then ≤ 5.0 × ULN

You may not qualify if:

• 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
• Pathological immunohistochemistry showing CD30 positivity and/or ALK positivity
• Patients planning to receive autologous or allogeneic transplantation as first-line consolidation therapy
• Confirmed central nervous system/meningeal involvement
• Significant uncontrolled comorbidities or infections, specifically:
• Uncontrolled infection requiring intravenous antibiotics
• Clinically significant heart disease (NYHA Class III or IV), unstable angina
• History of angioplasty, stent implantation, or myocardial infarction within the past 6 months
• Uncontrolled hypertension (systolic blood pressure \>160 mmHg) despite using two antihypertensive medications. (or diastolic blood pressure \>100 mmHg, measured twice consecutively, one week apart)
• Clinically significant cardiac arrhythmias
• Uncontrolled diabetes
• Known or detected positive for human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV-1), hepatitis B, or hepatitis C.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Leiden University Medical Center: collaborator

Study Sites (2)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

Shanghai, China

Location

Ruijin Hospital Wuxi Branch

Wuxi, China

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Lymphoma, Large-Cell, Anaplastic

Interventions

Aclarubicin; Cyclophosphamide; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Junmin Li

  Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiong Hu

CONTACT

86-13764313546; hj10709@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician of hematology

Model Details: The Bayesian Optimal Phase II (BOP2) clinical trial design was adopted. Efficacy and toxicity were assessed simultaneously. Based on previous data, the complete response (CR) rate for the CHOP regimen was 50%, while the expected CR rate for the CAOP regimen was 60%. The probability of grade ≥3 non-hematologic toxicity was 30% for patients receiving CHOP chemotherapy. We assume this can be reduced to 15% for the CAOP regimen. Non-hematologic toxicity was correlated with the chemotherapy regimen. Assuming an efficacy and toxicity analysis was performed after every 10 patients enrolled, the first phase planned to enroll 30 patients; assuming a 15% loss to follow-up, 36 subjects would be required.

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 17, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)