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Trial record 31 of 34 for:    Han weidong

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

Tracking Information
First Submitted Date  ICMJE August 10, 2017
First Posted Date  ICMJE August 16, 2017
Last Update Posted Date April 1, 2019
Actual Study Start Date  ICMJE September 11, 2017
Estimated Primary Completion Date July 21, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • 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.
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 15, 2017)
  • 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.
  • ORR assess by IRC [ Time Frame: 3 years ]
    rate of subjects achieved complete response plus partial response in all evaluable subjects
Change History Complete list of historical versions of study NCT03250962 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma
Official Title  ICMJE Anti-PD-1 Antibody SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma:an Open-label Phase II Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hodgkin Lymphoma
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: SHR-1210-plus-Decitabine
    Decitabine 10 mg/day, days 1-5; SHR-1210 200 mg, day 8, every 3 weeks.
    Interventions:
    • Drug: SHR-1210
    • Drug: Decitabine
  • Experimental: SHR-1210
    SHR-1210 200 mg, day 1, every 3 weeks.
    Intervention: Drug: SHR-1210
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2019)
280
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2017)
40
Estimated Study Completion Date  ICMJE March 21, 2025
Estimated Primary Completion Date July 21, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03250962
Other Study ID Numbers  ICMJE CHN-PLAGH-BT-023
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Study Protocol
Responsible Party Han weidong, Chinese PLA General Hospital
Study Sponsor  ICMJE Chinese PLA General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese PLA General Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP