SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma
- Registration Number
- NCT03250962
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 280
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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.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SHR-1210-plus-Decitabine SHR-1210 Decitabine 10 mg/day, days 1-5; SHR-1210 200 mg, day 8, every 3 weeks. SHR-1210 SHR-1210 SHR-1210 200 mg, day 1, every 3 weeks. SHR-1210-plus-Decitabine Decitabine Decitabine 10 mg/day, days 1-5; SHR-1210 200 mg, day 8, every 3 weeks.
- Primary Outcome Measures
Name Time Method stage II: duration of CR 5 years Time measured from the day of first documented CR to the date of first documented progression, or death from any cause.
stage I: Number of Subjects with treatment-related adverse events (AEs) 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 3 years rate of subjects achieved complete response in all evaluable subjects
- Secondary Outcome Measures
Name Time Method stage II: duration of response 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 5 years Time measured from the day of treatment to the date of first documented progression, or death from any cause.
Trial Locations
- Locations (1)
Biotherapeutic Department of Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China