Bendamustine Combined With Chidamide and Lenalidomide for Relapsed and Refractory PTCL Patients

Recruiting now · Not applicable

Conditions studied: Peripheral T-cell Lymphoma

In brief

To evaluate the efficacy and safety of bendamustine combined with chidamide and lenalidomide in R/R PTCL patients.

Key facts

Study ID

NCT07072221

Run by

The First Affiliated Hospital of Soochow University

People needed

40

Starts

2024-11-01

Expected to finish

2029-11-01

Last updated by the study team

2025-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years, male or female not limited;
• Patients must have the capacity to understand and willingly provide written informed consent;
• ECOG score 0-3 points;
• Expected lifespan>3 months;
• Patients with peripheral T-cell lymphoma (PTCL) confirmed by histopathology/cytology using the 2022 World Health Organization (WHO) Classification of Diseases;
• Measurable lesions with a short diameter of ≥15mm defined by PET/CT;
• R/R PTCL: patients with at least previous first-line treatment failure and no prior exposure to chidamide, lenalidomide and bendamustine;
• Any non-hematological toxicity, except hair loss, associated with prior treatment in patients with R/R disease, as per NCI CTCAE version 5.0, must be managed and resolved to at least grade 1;
• Appropriate organ function: Cardiac function: ejection fraction ≥ 50%, asymptomatic arrhythmia; Liver function: alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal, total bilirubin<2 times the upper limit of normal; Renal function: serum creatinine clearance rate ≥ 80 mL/min, creatinine<160 umol/l; Pulmonary function: Without oxygen inhalation, SPO2>90%, FEV1, FVC, and DLCO ≥ 50% predicted values;
• Adequate bone marrow reserve is defined as: Hemoglobin ≥ 9g/dL, Platelet count ≥ 70 × 10 \^ 9/L, The absolute value of neutrophils is ≥ 1.0 × 10 \^ 9/L, If accompanied by bone marrow invasion, platelet count ≥ 50 × 10 \^ 9/L, absolute neutrophil count ≥ 0.75 × 10 \^ 9/L, The number of CD34+cells is ≥ 2.0 × 109/kg;
• Subjects with fertility or potential for fertility must be willing to undergo contraception from the date of registration in this study until the study follow-up period;
• Patients with good compliance.

You may not qualify if…

• Patients with R/R disease previously used chidamide, lenalidomide and bendamustine, or received any other anti-tumor therapy within 4 weeks.
• Patients enrolled in another clinical study within 4 weeks;
• HIV infection and/or active hepatitis B or C;
• Uncontrolled active infections;
• Severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine>3 times the upper limit of normal);
• Existence of organic heart disease or severe arrhythmia, leading to clinical symptoms or abnormal heart function (NYHA functional class ≥ 2);
• Simultaneously present other tumors that require treatment or intervention;
• Previous or current history of vascular embolism;
• Pregnant or lactating women;
• In a state of severe immune suppression;
• Other psychological conditions that hinder patients from participating in research or signing informed consent forms.
• Patients are unlikely to complete all protocol study visits and procedures or do not meet the requirements for study participation.

Where it is running

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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