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

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Jul 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new combination of medicines—bendamustine, chidamide, and lenalidomide—to see how well they work and how safe they are for people with a type of blood cancer called peripheral T-cell lymphoma (PTCL) that has come back or didn’t respond to previous treatments. The goal is to find better treatment options for patients whose cancer has not improved after at least one earlier therapy.

Adults aged 18 and older with confirmed PTCL who have measurable cancer and who have not previously taken these three medicines may be eligible to join. Participants should be in reasonably good health, with heart, liver, kidney, and lung functions within certain limits, and must be able to understand the study and agree to take part. During the study, patients will receive the combination treatment and be closely monitored to see how their cancer responds and to watch for any side effects. It’s important to know that this study is currently recruiting new participants, and certain people—such as those with active infections, other serious health problems, or who are pregnant—would not be able to join. This trial offers hope for patients looking for new treatment options when previous ones haven’t worked.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years, male or female not limited;
• • 2. Patients must have the capacity to understand and willingly provide written informed consent;
• • 3. ECOG score 0-3 points;
• • 4. Expected lifespan\>3 months;
• • 5. Patients with peripheral T-cell lymphoma (PTCL) confirmed by histopathology/cytology using the 2022 World Health Organization (WHO) Classification of Diseases;
• • 6. Measurable lesions with a short diameter of ≥15mm defined by PET/CT;
• • 7. R/R PTCL: patients with at least previous first-line treatment failure and no prior exposure to chidamide, lenalidomide and bendamustine;
• • 8. 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;
• • 9. 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;
• • 10. 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;
• • 11. 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;
• • 12. Patients with good compliance.
• Exclusion Criteria:
• • 1. Patients with R/R disease previously used chidamide, lenalidomide and bendamustine, or received any other anti-tumor therapy within 4 weeks.
• • 2. Patients enrolled in another clinical study within 4 weeks;
• • 3. HIV infection and/or active hepatitis B or C;
• • 4. Uncontrolled active infections;
• • 5. Severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine\>3 times the upper limit of normal);
• • 6. Existence of organic heart disease or severe arrhythmia, leading to clinical symptoms or abnormal heart function (NYHA functional class ≥ 2);
• • 7. Simultaneously present other tumors that require treatment or intervention;
• • 8. Previous or current history of vascular embolism;
• • 9. Pregnant or lactating women;
• • 10. In a state of severe immune suppression;
• • 11. Other psychological conditions that hinder patients from participating in research or signing informed consent forms.
• • 12. Patients are unlikely to complete all protocol study visits and procedures or do not meet the requirements for study participation.