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

NCT ID: NCT04038411

Last Updated: 2019-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2022-04-01

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 Refractory NK/T cell Lymphoma. A total of 50 patients are planned to be enrolled into the study. The primary end points are objective responder rate (ORR) and progression free survival(PFS) and the secondary end points include overall survival(OS) , and adverse events.

Conditions

NK/T Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD-1 Antibody, chidamide, lenalidomide and etoposide

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.

Group Type: EXPERIMENTAL

PD-1 Antibody, chidamide, lenalidomide and etoposide

Intervention Type: DRUG

PD-1 blocking antibody inhibits PD-1. Chidamide is an histone deacetylase inhibitor. Lenalidomide is a potent inhibitor of TNF-α. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA.

Interventions

PD-1 Antibody, chidamide, lenalidomide and etoposide

PD-1 blocking antibody inhibits PD-1. Chidamide is an histone deacetylase inhibitor. Lenalidomide is a potent inhibitor of TNF-α. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA.

Intervention Type: DRUG

Eligibility 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;

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mingzhi Zhang

OTHER

Sponsor Role: lead

Responsible Party

Mingzhi Zhang

the director of oncology department of the first affiliated hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Oncology Department of The First Affilliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mingzhi D Zhang

Role: CONTACT

Mingzhi_zhang@126.com

+8613838565629 ext. +8613838565629

Facility Contacts

Mingzhi Zhang, Pro,Dr

Role: primary

Mingzhi_zhang@126.com

+8613838565629

Mingzhi Zhang, Zhang

Role: backup

Mingzhi_zhang@126.com

+8613838565629

Other Identifiers

hnslblzlzx2019070202

Identifier Type: -

Identifier Source: org_study_id