Status:
UNKNOWN
PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory NK/T Cell Lymphoma
Lead Sponsor:
Mingzhi Zhang
Conditions:
NK/T Cell Lymphoma
Eligibility:
All Genders
14-65 years
Phase:
PHASE4
Brief 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.
Detailed Description
This is a prospective, open-label, one-arm, multicenter clinical trial, aimed to evaluate the safety, tolerability, and efficacy of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide in Relapsed or ...
Eligibility Criteria
Inclusion
- age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score≤2;expected survival≥3 months;
- patients with NK/T Cell Lymphoma diagnosed by immuno-histochemistry (IHC) or fluorescence in situ hybridization (FISH);
- Refractory or relapse after at least 2 regimen;
- Once the patient received radiotherapy, need to be more than 3 months away from this treatment, and it is a non-primary recurrence;
- 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;
- At least one measurable lesion;
- There are no other serious diseases that conflict with this program, and the cardiopulmonary function is normal;
- Women of childbearing age must have a negative urine or blood pregnancy test, and male patients should be contraceptive during medication;
- There is no other antitumor treatment, but bisphosphonate for anti-bone metastasis treatment and other symptomatic treatment can be applied;
- Can understand the situation of this study and sign the informed consent voluntarily
Exclusion
- rejecting providing blood preparation;
- allergic to drug in this study or with hemophagocytic syndrome;
- rejecting adopting reliable contraceptive method in pregnancy or lactation period;
- uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac,lung,liver and pancreas）；
- with severe infection;
- with primary or secondary central nervous system tumor invasion;
- with Chemotherapy or radiotherapy contraindication;
- ever suffered with malignant tumor;
- Human immunodeficiency virus (HIV)-positive patients
- Drug abuse or long-term alcohol abuse that affects the evaluation of test results;
- Have peripheral nervous system disorder or mental disorder;
- Patients with immune system diseases;
- Those who have no legal capacity or whose research is affected by medical or ethical reasons;
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04038411
Start Date
April 1 2019
End Date
April 1 2022
Last Update
July 30 2019
Active Locations (1)
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1
Oncology Department of The First Affilliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052