PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory NK/T Cell Lymphoma

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To observe the safety, tolerability and clinical effects of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide in Relapsed or Refractory NK/T cell Lymphoma.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mingzhi Zhang
• Treatments: Antibodies; Etoposide; Etoposide phosphate; Immunoglobulins; Lenalidomide

Criteria

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;