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SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin 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: NCT03250962
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : October 1, 2018
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital

Brief Summary:
The purpose of this study is to evaluate whether treatment with the study drug decitabine in combination with SHR-1210 is safe and feasible, is more effective than treatment with SHR-1210 alone,and reverse the resistance of Anti-PD-1 antibody in patients with HL.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: SHR-1210 Drug: Decitabine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PD-1 Blockade With SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma:an Open-label Phase I/II Trial
Actual Study Start Date : September 11, 2017
Estimated Primary Completion Date : August 21, 2019
Estimated Study Completion Date : March 21, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Decitabine

Arm Intervention/treatment
Experimental: SHR-1210-plus-Decitabine Drug: SHR-1210
SHR-1210 is a humanized anti-PD-1 monoclonal antibody.

Drug: Decitabine
Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1 (DNMT1), which can increase tumor antigens and HLA expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function.

Experimental: SHR-1210 Drug: SHR-1210
SHR-1210 is a humanized anti-PD-1 monoclonal antibody.

Primary Outcome Measures :
  1. Number of Subjects with treatment-related adverse events (AEs) [ Time Frame: 2 years ]
    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.

  2. CRR assess by investigators per the 2014 Lugano classification [ Time Frame: 3 years ]
    rate of subjects achieved complete response in all evaluable subjects

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 1 Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).

    2 12 to 75 years of age. 3 ECOG performance of less than 2. 4 Life expectancy of at least 3 months. 5 Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria.

    6 Subjects must have received at least four prior chemotherapy regimen, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.Subjects with Anti-PD-1 antibody are eligible which must be resistance.

    7 Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

  • 1 Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.

    2 Serious uncontrolled medical disorders or active infections, pulmonary infection especially.

    3 Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .

    4 Prior organ allograft. 5 Women who are pregnant or breastfeeding. 6 Women with a positive pregnancy test on enrollment or prior to investigational product administration.

    7 Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

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): NCT03250962

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China, Beijing
Biotherapeutic Department of Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Weidong Han, Doctor    +86-10-66937463   
Contact: Qingming Yang, Doctor    +86-10-55499341   
Principal Investigator: Yang Liu, Doctor         
Principal Investigator: Chunmeng Wang, Master         
Principal Investigator: Wenying Zhang, Master         
Principal Investigator: Meixia Chen, Doctor         
Principal Investigator: Weidong Han, Doctor         
Principal Investigator: Qingming Yang, Doctor         
Principal Investigator: Qian Mei, Doctor         
Principal Investigator: Jing Nie, Doctor         
Sub-Investigator: Yan Zhang, Doctor         
Sub-Investigator: Kaichao Feng, Doctor         
Sub-Investigator: Jingdan Qiu, Doctor         
Sub-Investigator: Hejin Jia, Doctor         
Sub-Investigator: Xiang Li, Master         
Sub-Investigator: Liang Dong, Master         
Sub-Investigator: Lu Shi, Master         
Sponsors and Collaborators
Chinese PLA General Hospital

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Responsible Party: Han weidong, Principal Investigator, Chinese PLA General Hospital Identifier: NCT03250962     History of Changes
Other Study ID Numbers: CHN-PLAGH-BT-023
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study Protocol

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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 Han weidong, Chinese PLA General Hospital:
Relapsed/Refractory; Hodgkin Lymphoma;Decitabine; SHR-1210

Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors