Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
Overview
This is an open-label, Phase 2/3,multicenter and single-arm clinical trial of Camrelizumab plus decitabine for Anti-PD-1 treatment-naive patients with relapsed or refractory Hodgkin Lymphoma. The primary objective of this study is to evaluate the long-term response duration with Camrelizumab plus decitabine in relapsed or refractory Hodgkin Lymphoma.
Full Title of Study: “An Open-label, Multicenter, phase2/3 Study of Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: January 1, 2022
Interventions
- Drug: Camrelizumab and 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. Camrelizumab is a humanized anti-PD-1 monoclonal antibody.
Arms, Groups and Cohorts
- Experimental: Camrelizumab plus decitabine
- Decitabine 10 mg/day, days 1-5; Camrelizumab 200 mg, day 8, every 3 weeks.
Clinical Trial Outcome Measures
Primary Measures
- 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.
- 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
Participating in This Clinical Trial
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 two lines of prior regimens without Anti-PD-1 antibody treatment history, 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. – 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 nvestigational product administration. – 7 Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Gender Eligibility: All
Minimum Age: 12 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Chinese PLA General Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Han weidong, Professor – Chinese PLA General Hospital
- Overall Contact(s)
- Weidong Han, M.D., +861055499341, hanwdrsw@sina.com
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