Actively Recruiting
A Prospective, Exploratory Clinical Study of Bendamustine Combined With Chidamide and Lenalidomide for Relapsed and Refractory Peripheral T-cell Lymphoma Patients
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-07-18
40
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the combination of bendamustine, chidamide, and lenalidomide to assess its effectiveness and safety in adults with relapsed or refractory peripheral T-cell lymphoma (PTCL). This study focuses on patients who have previously received at least one systemic therapy and aims to evaluate outcomes such as complete response rate after treatment cycles. Participants will receive six 28-day cycles of the BCL regimen, with doses adjusted for patients over 70 years old. After four cycles, patients showing stable or progressive disease will leave the study, while those achieving partial or complete remission will continue with two more cycles. Afterwards, treatment diverges based on eligibility for autologous stem cell transplantation (ASCT): eligible patients undergo ASCT consolidation with conditioning therapy, while ineligible patients receive oral chidamide maintenance therapy for at least two years or until disease progression or unacceptable side effects. During the study, participants will be closely monitored through scans and laboratory tests to measure treatment response and safety. The primary outcome is the complete response rate after four cycles, with secondary outcomes including adverse events, overall response rate, and two-year survival and progression-free survival. Follow-up will continue up to two years after the last patient's treatment, ensuring ongoing assessment of health and treatment effects throughout the study period.
CONDITIONS
Brief Title
Bendamustine Combined With Chidamide and Lenalidomide for Relapsed and Refractory PTCL Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Ability to understand and provide written informed consent
- ECOG performance status between 0 and 3
- Expected lifespan longer than 3 months
- Confirmed peripheral T-cell lymphoma by pathology using 2022 WHO Classification
- Measurable lesions of at least 15mm by PET/CT
- Relapsed or refractory PTCL with at least one prior treatment and no prior use of bendamustine, chidamide, or lenalidomide
- Non-hematologic toxicities from prior treatments resolved to grade 1 or less (except hair loss)
- Adequate heart, liver, kidney, lung, and bone marrow function as specified
- Willingness to use contraception during the study and follow-up
- Good compliance with study requirements
You will not qualify if you...
- Prior use of bendamustine, chidamide, or lenalidomide or anti-tumor treatment within 4 weeks before enrollment
- Participation in another clinical study within 4 weeks
- HIV infection or active hepatitis B or C
- Uncontrolled active infections
- Severe liver or kidney dysfunction exceeding 3 times normal limits
- Significant heart disease or severe arrhythmia with symptoms
- Presence of other tumors requiring treatment
- History of vascular embolism
- Pregnant or breastfeeding women
- Severe immune suppression
- Psychological conditions preventing participation or consent
- Unlikely to complete all study visits or meet participation requirements
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 28 days each
Participants receive combination therapy with bendamustine, chidamide, and lenalidomide (BCL regimen) for up to 6 cycles. After 4 cycles, participants with stable or progressive disease will stop treatment. Responders continue for 2 additional cycles.
Up to 6 visits (in-person), one per cycle
Duration - ASCT consolidation or maintenance therapy for a minimum of 2 years or until progression/unacceptable toxicity
Participants who respond to treatment are divided into two groups: Cohort 1 participants eligible for autologous stem cell transplantation (ASCT) proceed to ASCT consolidation; Cohort 2 participants ineligible for ASCT receive oral chidamide maintenance therapy.
Cohort 1: ASCT procedure visit and follow-up visits; Cohort 2: Regular oral medication with periodic visits during maintenance
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
Z
Zhengming Jin
C
Changju Qu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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