Bendamustine plus chidamide and lenalidomide for relapsed or refractory peripheral T‑cell lymphoma

A Prospective, Exploratory Clinical Study of Bendamustine Combined With Chidamide and Lenalidomide for Relapsed and Refractory Peripheral T-cell Lymphoma Patients

This study will test whether combining bendamustine, chidamide, and lenalidomide helps adults with relapsed or refractory peripheral T‑cell lymphoma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT07072221 on ClinicalTrials.gov

What this trial studies

Adults with relapsed or refractory peripheral T‑cell lymphoma who have had at least one prior systemic therapy and measurable disease will receive a combination regimen of bendamustine, chidamide, and lenalidomide (BCL), with dose reductions for patients over 70. After four cycles, patients with partial or complete remission receive two additional cycles and are then routed to autologous stem cell transplant if eligible or to chidamide maintenance if ineligible. Patients with stable or progressive disease after four cycles are withdrawn from the protocol. The trial excludes patients previously treated with bendamustine, chidamide, or lenalidomide and requires adequate organ function and ECOG performance status up to 3.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically confirmed relapsed/refractory PTCL after at least one prior systemic therapy, measurable lesions, adequate organ function, ECOG 0–3, and no prior exposure to bendamustine, chidamide, or lenalidomide are ideal candidates.

Not a fit: Patients previously treated with any of the three study drugs, those with progressive or stable disease after four cycles, or those with insufficient organ function or life expectancy under three months are unlikely to benefit from this regimen.

Why it matters

Potential benefit: If successful, the BCL combination could increase response rates and help more patients reach transplant or durable remission with maintenance therapy.

How similar studies have performed: Individual agents (chidamide, lenalidomide, bendamustine) have shown activity in T‑cell or other lymphomas and chidamide is approved for PTCL in China, but the three‑drug BCL combination is a relatively novel regimen.

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.

Where this trial is running

Suzhou, Jiangsu

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

Study contacts

• Study coordinator: Zhengming Jin

Conditions Peripheral T-cell Lymphoma; Bendamustine; Chidamide; Lenalidomide