Back to resultsSHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma
Primary Purpose
Hodgkin Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-1210
Decitabine
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Relapsed/Refractory; Hodgkin Lymphoma；Decitabine; SHR-1210
Eligibility 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.
Sites / Locations
- Biotherapeutic Department of Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SHR-1210-plus-Decitabine
SHR-1210
Arm Description
Decitabine 10 mg/day, days 1-5; SHR-1210 200 mg, day 8, every 3 weeks.
SHR-1210 200 mg, day 1, every 3 weeks.
Outcomes
Primary Outcome Measures
stage I: Number of Subjects with treatment-related adverse events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
stage I: CRR assess by investigators per the 2014 Lugano classification
rate of subjects achieved complete response in all evaluable subjects
stage II: duration of CR
Time measured from the day of first documented CR to the date of first documented progression, or death from any cause.
Secondary Outcome Measures
stage II: duration of response
Time measured from the day of first documented PR or CR to the date of first documented progression, or death from any cause.
stage II: Progression free survival
Time measured from the day of treatment to the date of first documented progression, or death from any cause.
Full Information
NCT ID
NCT03250962
First Posted
August 10, 2017
Last Updated
March 28, 2019
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03250962
Brief Title
SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2017 (Actual)
Primary Completion Date
July 21, 2022 (Anticipated)
Study Completion Date
March 21, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
Keywords
Relapsed/Refractory; Hodgkin Lymphoma；Decitabine; SHR-1210
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR-1210-plus-Decitabine
Arm Type
Experimental
Arm Description
Decitabine 10 mg/day, days 1-5; SHR-1210 200 mg, day 8, every 3 weeks.
Arm Title
SHR-1210
Arm Type
Experimental
Arm Description
SHR-1210 200 mg, day 1, every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
SHR-1210
Intervention Description
SHR-1210 is a humanized anti-PD-1 monoclonal antibody.
Intervention Type
Drug
Intervention Name(s)
Decitabine
Intervention Description
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.
Primary Outcome Measure Information:
Title
stage I: Number of Subjects with treatment-related adverse events (AEs)
Description
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
Time Frame
2 years
Title
stage I: CRR assess by investigators per the 2014 Lugano classification
Description
rate of subjects achieved complete response in all evaluable subjects
Time Frame
3 years
Title
stage II: duration of CR
Description
Time measured from the day of first documented CR to the date of first documented progression, or death from any cause.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
stage II: duration of response
Description
Time measured from the day of first documented PR or CR to the date of first documented progression, or death from any cause.
Time Frame
5 years
Title
stage II: Progression free survival
Description
Time measured from the day of treatment to the date of first documented progression, or death from any cause.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Biotherapeutic Department of Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Han, M.D
Phone
+86-10-66937463
Email
hanwdrsw@sina.com
First Name & Middle Initial & Last Name & Degree
Qingming Yang, M.D
Phone
+86-10-55499341
Email
yangqm@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Weidong Han, M.D
First Name & Middle Initial & Last Name & Degree
Jing Nie, Ph.D
First Name & Middle Initial & Last Name & Degree
Qingming Yang, M.D
First Name & Middle Initial & Last Name & Degree
Yang Liu, M.D
First Name & Middle Initial & Last Name & Degree
Chunmeng Wang, M.S
First Name & Middle Initial & Last Name & Degree
Wenjing Ku, M.S
First Name & Middle Initial & Last Name & Degree
Yan Zhang, M.S
First Name & Middle Initial & Last Name & Degree
Meixia Chen, M.S
First Name & Middle Initial & Last Name & Degree
Qian Mei, M.D
First Name & Middle Initial & Last Name & Degree
Xiang Li, B.S
First Name & Middle Initial & Last Name & Degree
Jiejie Liu, B.S
First Name & Middle Initial & Last Name & Degree
Liang Dong, B.S
First Name & Middle Initial & Last Name & Degree
Jie Bai, M.S
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Study Protocol
Citations:
PubMed Identifier
33820822
Citation
Liu Y, Wang C, Li X, Dong L, Yang Q, Chen M, Shi F, Brock M, Liu M, Mei Q, Liu J, Nie J, Han W. Improved clinical outcome in a randomized phase II study of anti-PD-1 camrelizumab plus decitabine in relapsed/refractory Hodgkin lymphoma. J Immunother Cancer. 2021 Apr;9(4):e002347. doi: 10.1136/jitc-2021-002347.
Results Reference
derived
PubMed Identifier
33674274
Citation
Wang C, Liu Y, Dong L, Li X, Yang Q, Brock MV, Mei Q, Liu J, Chen M, Shi F, Liu M, Nie J, Han W. Efficacy of Decitabine plus Anti-PD-1 Camrelizumab in Patients with Hodgkin Lymphoma Who Progressed or Relapsed after PD-1 Blockade Monotherapy. Clin Cancer Res. 2021 May 15;27(10):2782-2791. doi: 10.1158/1078-0432.CCR-21-0133. Epub 2021 Mar 5.
Results Reference
derived
PubMed Identifier
31039052
Citation
Nie J, Wang C, Liu Y, Yang Q, Mei Q, Dong L, Li X, Liu J, Ku W, Zhang Y, Chen M, An X, Shi L, Brock MV, Bai J, Han W. Addition of Low-Dose Decitabine to Anti-PD-1 Antibody Camrelizumab in Relapsed/Refractory Classical Hodgkin Lymphoma. J Clin Oncol. 2019 Jun 10;37(17):1479-1489. doi: 10.1200/JCO.18.02151. Epub 2019 Apr 30.
Results Reference
derived
Learn more about this trial
SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma
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