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SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT03250962
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : August 16, 2017
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Study Start Date : September 4, 2017
Estimated Primary Completion Date : August 21, 2018
Estimated Study Completion Date : March 21, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Decitabine
U.S. FDA Resources

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. ORR assess by IRC [ Time Frame: 3 years ]
    rate of subjects achieved complete response plus partial response in all evaluable subjects



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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

    2 12 to 80 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 two 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 ClinicalTrials.gov identifier (NCT number): NCT03250962


Locations
China, Beijing
Biotherapeutic Department of Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Weidong Han, Doctor    +86-10-66937463    hanwdrsw@sina.com   
Contact: Qingming Yang, Doctor    +86-10-55499341    yangqm@medmail.com.cn   
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

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

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:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Decitabine
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors