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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