Clinical trial · Interventional
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
NCT07072221CI-TRIAL-00092348recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of bendamustine combined with chidamide and lenalidomide in R/R PTCL patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCL regimen | Drug | — | UNRESOLVED |
| Cohort 1 (ASCT-eligible) | Procedure | — | UNRESOLVED |
| Cohort 2 (ASCT--ineligible) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1 (ASCT-eligible)
- description
- Patients who achieved PR/CR after 6 cycles of BCL regimen and were eligible to ASCT will proceed to ASCT consolidation
- interventionNames
- Drug: BCL regimen
- Procedure: Cohort 1 (ASCT-eligible)
- type
- EXPERIMENTAL
- label
- Cohort 2 (ASCT-ineligible)
- description
- 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)
- interventionNames
- Drug: BCL regimen
- Drug: Cohort 2 (ASCT--ineligible)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.