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RecruitingNCT07072221Updated Jul 18, 2025

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

An interventional study of BCL regimen and Cohort 1 (ASCT-eligible) in Peripheral T-cell Lymphoma, sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-18.

Sponsored by The First Affiliated Hospital of Soochow University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Nov 2024, registered Jul 2025).
  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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 After 4 cycles of BCL regimen, patients demonstrating stable disease(SD) or progressive disease (PD) will be withdrawn from the study.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)

02

Conditions studied

  • Peripheral T-cell Lymphoma

Keywords

  • Bendamustine
  • Chidamide
  • Lenalidomide
03

In context

Lymphoma, T-Cell, Peripheral

604 studies on the registry are indexed under Lymphoma, T-Cell, Peripheral; 133 are open to participants now.

This study's planned enrollment of 40 is close to the median of 38 across 526 interventional studies indexed under Lymphoma, T-Cell, Peripheral.

Browse Lymphoma, T-Cell, Peripheral studies →

Lead sponsor

The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Cohort 1 (ASCT-eligible)

    Patients who achieved PR/CR after 6 cycles of BCL regimen and were eligible to ASCT will proceed to ASCT consolidation

    Drug: BCL regimen · Procedure: Cohort 1 (ASCT-eligible)

  • Experimental
    Cohort 2 (ASCT-ineligible)

    Patients who achieved PR/CR after 6 cycles of BCL regimen and were ineligible to ASCT will receive oral chidamide maintenance therapy (minimum 2 years or until progression/unacceptable toxicity)

    Drug: BCL regimen · Drug: Cohort 2 (ASCT--ineligible)

Interventions

  • DrugBCL regimen

    Induction therapy period (28 days\*6) Bendamustine; Specification: 100mg per vial; 90mg/m2 d1-2, ivgtt.; for age≤70 years; 70mg/m2 d1-2, ivgtt.; for age\>70 years; Chidamide; Specification: 5mg per tablet; 20mg biw for 2 weeks, po.; for age≤70 years; 15mg biw for 2 weeks, po.; for age\>70 years; Lenalidomide Specification:10mg per tablet; 10mg qd d1-d21, po.; for age≤70 years; 10mg qd d1-d14, po.; for age\>70 years;

  • ProcedureCohort 1 (ASCT-eligible)

    Autologous hematopoietic stem cell transplantation SEAM conditioning Simustine 250mg/m2 orally, d1; Etoposide 200mg/m2 intravenous infusion, d2-d5; Cytarabine 400mg/m2 intravenous infusion, d2-d5; Metformin 140mg/m2 intravenous infusion, d6;

  • DrugCohort 2 (ASCT--ineligible)

    Maintenance therapy period (2 years) Chidamide; Specification: 5mg per tablet; 15mg biw for 2 weeks per 3 weeks, po.;

06

What researchers measure

Primary outcomes

  1. Complete response rate(CRR)

    The rate of patients who achieved CR after 4 cycles of bendamustine combined with chidamide and lenalidomide therapy (BCL regimen).

    Time frame: At the end of 4 cycles of BCL regimen (each cycle is 28 days)

Secondary outcomes

  1. Main adverse events

    The safety and tolerability of the BCL regimen measured by the major adverse events.

    Time frame: From enrollment to 1 month after the end of last patient's treatment

  2. Overall response rate(ORR)

    The rate of patients who achieved CR or PR after treatment of 4 cycles of BCL regimen

    Time frame: At the end of 4 cycles of BCL regimen (each cycle is 28 days)

  3. 2-year Overall survival(OS)

    OS will be assessed from the start of the BCL treatment to the date of death or end of follow-up.

    Time frame: From enrollment to 2 years after the last patient's treatment

  4. 2-year progression-free survival(PFS)

    PFS will be assessed from the start of the BCL treatment to the date of progression, relapse, death or end of follow-up.

    Time frame: From enrollment to 2 years after the last patient's treatment

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Soochow University
    Suzhou, Jiangsu 215006, China
    • Zhengming Jin · Contact · jinzhengming519519@163.com · 67781856
    • Changju Qu · Contact · qcj310@163.com · 67781856
    • Zhengming Jin · Principal investigator
    • Changju Qu · Principal investigator
    • Nana Ping · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07072221
Lead sponsor
The First Affiliated Hospital of Soochow University
Responsible party
Sponsor
First posted
Jul 18, 2025
Start date
Nov 1, 2024
Primary completion
Aug 1, 2029 (estimated)
Completion
Nov 1, 2029 (estimated)
Last update
Jul 18, 2025

Study contacts

Zhengming Jin
Contact
jinzhengming519519@163.com
67781856
Changju Qu
Contact
qcj310@163.com
67781856

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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