Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

An Open-label, Multicenter, phase2/3 Study of Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

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.

Study Overview

• Status: Recruiting
• Conditions: Hodgkin Lymphoma
• Intervention / Treatment: Drug: Camrelizumab and Decitabine

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Weidong Han, M.D.; Phone Number: +861055499341; Email: hanwdrsw@sina.com

Study Locations

• China
  • Beijing, China, 100853
    • Recruiting
    • Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Camrelizumab plus decitabine; Decitabine 10 mg/day, days 1-5; Camrelizumab 200 mg, day 8, every 3 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years
Progression free survival	Time measured from the day of treatment to the date of first documented progression, or death from any cause	5 years

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Decitabine
• Other Study ID Numbers: CHN-PLAGH-BT-056

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No