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

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ClinicalTrials.gov Identifier: NCT04038411
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Mingzhi Zhang, Zhengzhou University

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.

Condition or disease Intervention/treatment Phase
NK/T Cell Lymphoma Drug: PD-1 Antibody, chidamide, lenalidomide and etoposide Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-arm, Multi-center Clinical Study of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory Natural Killer/T Cell Lymphoma
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2022


Arm Intervention/treatment
Experimental: 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.
Drug: 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.




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: From date of randomization until the date of first date tumor volume has reduced, assessed up to 36 months ]
    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 Outcome Measures :
  1. Progression-free Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months ]
    The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death

  2. Overall Survival [ Time Frame: From date of randomization until date of death from any cause, assessed up to 36 months ]
    Time from randomization to death for any reason.



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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038411


Contacts
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Contact: Mingzhi D Zhang +8613838565629 ext +8613838565629 Mingzhi_zhang@126.com

Locations
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China, Henan
Oncology Department of The First Affilliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Mingzhi Zhang, Pro,Dr    +8613838565629    Mingzhi_zhang@126.com   
Contact: Mingzhi Zhang, Zhang    +8613838565629    Mingzhi_zhang@126.com   
Sponsors and Collaborators
Mingzhi Zhang

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Responsible Party: Mingzhi Zhang, the director of oncology department of the first affiliated hospital, Zhengzhou University
ClinicalTrials.gov Identifier: NCT04038411     History of Changes
Other Study ID Numbers: hnslblzlzx2019070202
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mingzhi Zhang, Zhengzhou University:
PD-1 Antibody
chidamide
lenalidomide
etoposide
NK/T-cell Lymphoma
Additional relevant MeSH terms:
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Lymphoma, T-Cell
Lenalidomide
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Etoposide
Etoposide phosphate
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action