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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 : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital

Brief Summary:
This is a two-stage, Phase II clinical trial for patients with relapsed or refractory Hodgkin Lymphoma. The purpose of stage I is to evaluate whether treatment with the study drug decitabine in combination with SHR-1210 is safe and more effective than treatment with SHR-1210 alone; and reverse the resistance of anti-PD-1 antibody in patients with HL who had previously treated with anti-PD-1 monotherapy. If it is deemed that the combination therapy is more efficacious than SHR-1210 monotherapy (The CR rate of the combination group is at least 30% higher compared to monotherapy group with a minimal follow-up of 6 months in predicting 60 subjects naïve to anti-PD-1 antibody who are randomly assigned (2:1) to the above two groups), the stage II study will be revised to a multicohort, decitabine-plus-SHR1210 single-arm clinical trial. The primary objective of stage II study is to evaluate the long-term response duration with decitabine-plus-SHR-1210 in relapsed or refractory Hodgkin Lymphoma.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anti-PD-1 Antibody SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma:an Open-label Phase II Trial
Actual Study Start Date : September 11, 2017
Estimated Primary Completion Date : July 21, 2022
Estimated Study Completion Date : March 21, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Decitabine

Arm Intervention/treatment
Experimental: SHR-1210-plus-Decitabine
Decitabine 10 mg/day, days 1-5; SHR-1210 200 mg, day 8, every 3 weeks.
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
SHR-1210 200 mg, day 1, every 3 weeks.
Drug: SHR-1210
SHR-1210 is a humanized anti-PD-1 monoclonal antibody.




Primary Outcome Measures :
  1. stage I: 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. stage I: CRR assess by investigators per the 2014 Lugano classification [ Time Frame: 3 years ]
    rate of subjects achieved complete response in all evaluable subjects

  3. stage II: duration of CR [ Time Frame: 5 years ]
    Time measured from the day of first documented CR to the date of first documented progression, or death from any cause.


Secondary Outcome Measures :
  1. stage II: duration of response [ Time Frame: 5 years ]
    Time measured from the day of first documented PR or CR to the date of first documented progression, or death from any cause.

  2. stage II: Progression free survival [ Time Frame: 5 years ]
    Time measured from the day of treatment to the date of first documented progression, or death from any cause.



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03250962


Locations
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China, Beijing
Biotherapeutic Department of Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Weidong Han, M.D    +86-10-66937463    hanwdrsw@sina.com   
Contact: Qingming Yang, M.D    +86-10-55499341    yangqm@medmail.com.cn   
Principal Investigator: Weidong Han, M.D         
Principal Investigator: Jing Nie, Ph.D         
Principal Investigator: Qingming Yang, M.D         
Principal Investigator: Yang Liu, M.D         
Principal Investigator: Chunmeng Wang, M.S         
Principal Investigator: Wenjing Ku, M.S         
Sub-Investigator: Yan Zhang, M.S         
Sub-Investigator: Meixia Chen, M.S         
Sub-Investigator: Qian Mei, M.D         
Sub-Investigator: Xiang Li, B.S         
Sub-Investigator: Jiejie Liu, B.S         
Sub-Investigator: Liang Dong, B.S         
Sub-Investigator: Jie Bai, M.S         
Sponsors and Collaborators
Chinese PLA General Hospital

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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: April 1, 2019
Last Verified: March 2019
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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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors