Clinical trial · Interventional
PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory NK/T Cell Lymphoma
Single-arm, Multi-center Clinical Study of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory Natural Killer/T Cell Lymphoma
NCT04038411CI-TRIAL-00039799unknownPhase 4ClinicalTrials.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 observe the safety, tolerability and clinical effects of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide in Relapsed or Refractory NK/T cell Lymphoma.
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 |
|---|---|---|---|
| NK/T Cell Lymphoma | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 Antibody, chidamide, lenalidomide and etoposide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD-1 Antibody, chidamide, lenalidomide and etoposide
- description
- PD-1 Antibody: 240mg, d1, Chidamide: 20mg, twice a week, Lenalidomide: 25mg, d1-14 Etoposide:100mg/m2, d1-3 and 21 days made one treatment cycle.
- interventionNames
- Drug: PD-1 Antibody, chidamide, lenalidomide and etoposide
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- From date of randomization until the date of first date tumor volume has reduced, assessed up to 36 months
- description
- The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete and partial mitigation.
Secondary outcomes (2)
- measure
- Progression-free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score≤2;expected survival≥3 months; 2. patients with NK/T Cell Lymphoma diagnosed by immuno-histochemistry (IHC) or fluorescence in situ hybridization (FISH); 3. Refractory or relapse after at least 2 regimen; 4. Once the patient received radiotherapy, need to be more than 3 months away from this treatment, and it is a non-primary recurrence; 5. No chemotherapy contraindications: hemoglobin ≥ 100g / L, absolute neutrophil count ≥ 1.5 × 109 / L, platelets ≥ 80 × 109 / L, ALT, AST ≤ 2 times the upper limit of normal, serum total bilirubin ≤ 1.5 times normal Upper limit, serum creatinine ≥ 1.5 times normal upper limit, serum protein ≥ 30g / L; 6. At least one measurable lesion; 7. There are no other serious diseases that conflict with this program, and the cardiopulmonary function is normal; 8. Women of childbearing age must have a negative urine or blood pregnancy test, and male patients should be contraceptive during medication; 9. There is no other antitumor treatment, but bisphosphonate for anti-bone metastasis treatment and other symptomatic treatment can be applied; 10. Can understand the situation of this study and sign the informed consent voluntarily Exclusion Criteria: 1. rejecting providing blood preparation; 2. allergic to drug in this study or with hemophagocytic syndrome; 3. rejecting adopting reliable contraceptive method in pregnancy or lactation period; 4. uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac,lung,liver and pancreas); 5. with severe infection; 6. with primary or secondary central nervous system tumor invasion; 7. with Chemotherapy or radiotherapy contraindication; 8. ever suffered with malignant tumor; 9. Human immunodeficiency virus (HIV)-positive patients 10. Drug abuse or long-term alcohol abuse that affects the evaluation of test results; 11. Have peripheral nervous system disorder or mental disorder; 12. Patients with immune system diseases; 13. Those who have no legal capacity or whose research is affected by medical or ethical reasons;
References
Publications (0)
Data not yet available
No reference posted for this study.