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PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Peripheral T-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04040491
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Information provided by (Responsible Party):
Mingzhi Zhang, Zhengzhou University

Brief Summary:
To observe the safety, tolerability and clinical effects of PD-1, chidamide, lenalidomide and etoposide in the treatment of newly diagnosed peripheral T-cell lymphoma.

Condition or disease Intervention/treatment Phase
Newly Diagnosed Peripheral T-cell Lymphoma Drug: PD-1 blocking antibody, chidamide, lenalidomide and etoposide Phase 4

Detailed Description:
Patients with peripheral T-cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional CHOP regimen. The investigators have been proceeding this trial to evaluate the efficacy and safety of the PD-1, chidamide, lenalidomide and etoposide in the treatment of newly diagnosed peripheral T-cell lymphoma.

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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 Peripheral 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 blocking 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 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.

  2. 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

  3. 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

Information from the National Library of Medicine

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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

Inclusion Criteria:

  • age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score≤3;expected survival≥3 months
  • patients with Peripheral T-cell Lymphoma diagnosed by immuno-histochemistry (IHC);
  • acceptable hematological indicators, no chemotherapy contraindications;
  • total bilirubin ≤ 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5 x upper age limit (ULN), if the abnormal laboratory parameters are considered to be caused by lymphoma, patients Eligible conditions should be adjusted to be incorporated into the group;
  • At least one measurable lesion by CT or PET-CT(Positron Emission Tomography-Computed Tomography);
  • exclude other major diseases, normal heart and lung function;
  • Female patients of childbearing age are negative for pregnancy test;
  • Cooperate with follow-up;
  • There are no other related treatments including traditional Chinese medicine, immunotherapy, and biologic therapy (except for the treatment of anti-bone metastases and other symptoms);
  • Signing informed consent *: Pathological histology must be consulted by a pathologist at a provincial hospital.

Exclusion Criteria:

  • Patients with ALK-positive Anaplastic Large Cell Lymphoma or angioimmunoblastic T-cell lymphoma
  • rejecting providing blood preparation;
  • allergic to drug in this study and with metabolic block;
  • 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 immunotherapy or radiotherapy contraindication;
  • ever suffered with malignant tumor;
  • having peripheral nervous system disorder or dysphrenia;
  • with no legal capacity,medical or ethical reasons affecting research proceeding;
  • participating other clinical trials simultaneously;
  • adopting other anti-tumor medicine excluding this research;
  • Patients with immunodeficiency, such as primary immunodeficiency syndrome or organ transplant recipients
  • Human immunodeficiency virus (HIV)-positive patients
  • the researchers considering it inappropriate to participate in the study.
  • Patients with immune system diseases

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 identifier (NCT number): NCT04040491

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Contact: Mingzhi D Zhang +8613838565629 ext +8613838565629

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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   
Contact: Mingzhi Zhang, Zhang    +8613838565629   
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 Identifier: NCT04040491     History of Changes
Other Study ID Numbers: hnslblzlzx20190702
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mingzhi Zhang, Zhengzhou University:
Peripheral T-cell Lymphoma
Additional relevant MeSH terms:
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Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Etoposide phosphate
Antibodies, Blocking
Immunologic Factors
Physiological Effects of Drugs
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action