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Bendamustine Combined With Chidamide and Lenalidomide for Relapsed and Refractory PTCL Patients | Clinical Trials | Clareo Health

RECRUITINGNA

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

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

NCT07072221•The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

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

Detailed Description

This study will enroll relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL) patients aged over 18 years who have received at least one line of prior systemic therapy. Participants will receive combination therapy with bendamustine, chidamide, and lenalidomide (BCL regimen), with dose reduction for patients \>70 years old. After 4 cycles of BCL regimen, patients demonstrating stable disease(SD) or progressive disease (PD) will be withdrawn from the study. Patients achieving partial remission(PR) or complete remission(CR) will receive another 2 cycles of BCL regimen followed by stratification treatment as followings: Cohort 1 (ASCT-eligible): Responders will proceed to autologous stem cell transplantation (ASCT) consolidation Cohort 2 (ASCT-ineligible): Responders will receive oral chidamide maintenance therapy (minimum 2 years or until progression/unacceptable toxicity)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+2 more criteria

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;
+2 more criteria

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Key Dates

Start Date

November 1, 2024

Primary Completion Date

August 1, 2029

Completion Date

November 1, 2029

Last Updated

July 18, 2025

Enrollment

ESTIMATED participants

Conditions

Peripheral T-cell Lymphoma

Interventions

BCL regimen

DRUG

Cohort 1 (ASCT-eligible)

PROCEDURE

Cohort 2 (ASCT--ineligible)

DRUG

Contacts

Zhengming Jin

CONTACT

67781856 jinzhengming519519@163.com

Changju Qu

CONTACT

67781856 qcj310@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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