The Clinical Trial of Chidamide+Decitabine+Camrelizumab Versus Decitabine+Camrelizumab in Anti-PD-1 Antibody Resistant Patients With Classical Hodgkin Lymphoma.

A Randomized, Open-label, Phase 2 Trial of Chidamide+Decitabine+Camrelizumab Versus Decitabine+Camrelizumab in Anti-PD-1 Antibody Resistant Patients With Classical Hodgkin Lymphoma.

This open-label, randomized, two-arm, phase 2 study has the primary objective of comparing the ORR obtained with Chidamide+Decitabine+Camrelizumab against that obtained with Decitabine+Camrelizumab in patients with Hodgkin Lymphoma who were confirmed resistant to Anti-PD-1 antibody therapy.

Study Overview

• Status: Recruiting
• Conditions: Hodgkin Lymphoma; Anti-PD-1 Antibody Resistant
• Intervention / Treatment: Drug: Chidamide; Decitabine; Camrelizumab; Drug: Decitabine+Camrelizumab

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

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

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Biotherapeutic Department of Chinese PLA General Hospital
      • Contact: Weidong D Han, Doctor; Phone Number: +86-10-66937463; Email: hanwdrsw@sina.com
      • Contact: C, Doctor
      • Sub-Investigator: Chunmeng Wang
      • Sub-Investigator: Jing Nie
      • Sub-Investigator: Xiang Li
      • Sub-Investigator: Liang Dong
      • Sub-Investigator: Minhang Zhou
      • Sub-Investigator: Jie Bai

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 Anti-PD-1 antibody therapy and were confirmed Anti-PD-1 antibody resistant. 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 investigational product administration.
7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chidamide+Decitabine+Camrelizumab	Drug: Chidamide; Decitabine; Camrelizumab; Chidamide is a novel and orally active benzamide class of HDAC inhibitor that selectively inhibits activity of HDAC1, 2, 3 and 10, which can Induce tumor-cell apoptosis, suppress cell proliferation and enhance immune surveillance. 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.
Active Comparator: Decitabine+Camrelizumab	Drug: Decitabine+Camrelizumab; Decitabine+Camrelizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR assess by investigators per the 2014 Lugano classification	rate of subjects achieved objective response in all evaluable subjects	3 years
Number of Subjects with treatment-related adverse events (AEs)	Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.	3 years

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 14, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 17, 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-057

Drug and device information, study documents

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