Peripheral T-cell LymphomaNCT07072221
Bendamustine Combined With Chidamide and Lenalidomide for Relapsed and Refractory PTCL Patients
A study testing BCL regimen, Cohort 1 (ASCT-eligible) and Cohort 2 (ASCT--ineligible) in people with Peripheral T-cell Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of bendamustine combined with chidamide and lenalidomide in R/R PTCL patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- BCL regimen, Cohort 1 (ASCT-eligible) and Cohort 2 (ASCT--ineligible)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Zhengming Jin, 67781856, jinzhengming519519@163.com
Changju Qu, 67781856, qcj310@163.com
About this study
Official title: A Prospective, Exploratory Clinical Study of Bendamustine Combined With Chidamide and Lenalidomide for Relapsed and Refractory Peripheral T-cell Lymphoma Patients
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)
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- BCL regimen, Cohort 1 (ASCT-eligible), Cohort 2 (ASCT--ineligible)
- Keywords
- Bendamustine, Chidamide, Lenalidomide
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCL regimenDrug
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;
Cohort 1 (ASCT-eligible)Procedure or surgery
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;
Cohort 2 (ASCT--ineligible)Drug
Maintenance therapy period (2 years)
Chidamide; Specification: 5mg per tablet; 15mg biw for 2 weeks per 3 weeks, po.;
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (ASCT-eligible) | Experimental | Patients who achieved PR/CR after 6 cycles of BCL regimen and were eligible to ASCT will proceed to ASCT consolidation Receives: Drug: BCL regimen; Procedure: Cohort 1 (ASCT-eligible) |
| Cohort 2 (ASCT-ineligible) | Experimental | 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) Receives: Drug: BCL regimen; Drug: Cohort 2 (ASCT--ineligible) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate(CRR)
The rate of patients who achieved CR after 4 cycles of bendamustine combined with chidamide and lenalidomide therapy (BCL regimen).
Measured: At the end of 4 cycles of BCL regimen (each cycle is 28 days)
Secondary outcomes (4)
Main adverse events
The safety and tolerability of the BCL regimen measured by the major adverse events.
Measured: From enrollment to 1 month after the end of last patient's treatment
Overall response rate(ORR)
The rate of patients who achieved CR or PR after treatment of 4 cycles of BCL regimen
Measured: At the end of 4 cycles of BCL regimen (each cycle is 28 days)
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.
Measured: From enrollment to 2 years after the last patient's treatment
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.
Measured: From enrollment to 2 years after the last patient's treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Nov 2024
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072221
- Sponsor's protocol ID
- 2024473
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Exploratory Clinical Study of Bendamustine Combined With Chidamide and Lenalidomide for Relapsed and Refractory Peripheral T-cell Lymphoma Patients
- ClinicalTrials.gov ID
- NCT07072221
- Acronym / sponsor ID
- 2024473
- Conditions
- Peripheral T-cell Lymphoma
- Keywords
- Bendamustine, Chidamide, Lenalidomide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (ASCT-eligible) | Experimental | Drug: BCL regimen, Procedure: 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 |
| Cohort 2 (ASCT-ineligible) | Experimental | Drug: BCL regimen, Drug: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCL regimenInduction 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; | Drug | Cohort 1 (ASCT-eligible), Cohort 2 (ASCT-ineligible) |
| Cohort 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; | Procedure or surgery | Cohort 1 (ASCT-eligible) |
| Cohort 2 (ASCT--ineligible)Maintenance therapy period (2 years) Chidamide; Specification: 5mg per tablet; 15mg biw for 2 weeks per 3 weeks, po.; | Drug | Cohort 2 (ASCT-ineligible) |
Primary outcome
Complete response rate(CRR)
Time frame: At the end of 4 cycles of BCL regimen (each cycle is 28 days)
The rate of patients who achieved CR after 4 cycles of bendamustine combined with chidamide and lenalidomide therapy (BCL regimen).
4 secondary outcomes
Main adverse events
Time frame: From enrollment to 1 month after the end of last patient's treatment
Overall response rate(ORR)
Time frame: At the end of 4 cycles of BCL regimen (each cycle is 28 days)
2-year Overall survival(OS)
Time frame: From enrollment to 2 years after the last patient's treatment
2-year progression-free survival(PFS)
Time frame: From enrollment to 2 years after the last patient's treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCL regimen, Cohort 1 (ASCT-eligible) and Cohort 2 (ASCT--ineligible) in people with Peripheral T-cell Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhengming Jin (67781856, jinzhengming519519@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate(CRR) (time frame: At the end of 4 cycles of BCL regimen (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.