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

Primary Purpose

Hodgkin Lymphoma, Anti-PD-1 Antibody Resistant

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chidamide; Decitabine; Camrelizumab
Decitabine+Camrelizumab
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Biotherapeutic Department of Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chidamide+Decitabine+Camrelizumab

Decitabine+Camrelizumab

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 13, 2020
Last Updated
August 17, 2020
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04514081
Brief Title
The Clinical Trial of Chidamide+Decitabine+Camrelizumab Versus Decitabine+Camrelizumab in Anti-PD-1 Antibody Resistant Patients With Classical Hodgkin Lymphoma.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma, Anti-PD-1 Antibody Resistant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chidamide+Decitabine+Camrelizumab
Arm Type
Experimental
Arm Title
Decitabine+Camrelizumab
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Chidamide; Decitabine; Camrelizumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Decitabine+Camrelizumab
Intervention Description
Decitabine+Camrelizumab
Primary Outcome Measure Information:
Title
ORR assess by investigators per the 2014 Lugano classification
Description
rate of subjects achieved objective response in all evaluable subjects
Time Frame
3 years
Title
Number of Subjects with treatment-related adverse events (AEs)
Description
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL). 12 to 75 years of age. ECOG performance of less than 2. Life expectancy of at least 3 months. Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria. 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. Subjects must have adequate marrow, live, renal and heart functions. Exclusion Criteria: Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. Serious uncontrolled medical disorders or active infections, pulmonary infection especially. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month. Prior organ allograft. Women who are pregnant or breastfeeding. Women with a positive pregnancy test on enrollment or prior to investigational product administration. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weidong Han, M.D.
Phone
+861055499341
Email
hanwdrsw@sina.com
Facility Information:
Facility Name
Biotherapeutic Department of Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong D Han, Doctor
Phone
+86-10-66937463
Email
hanwdrsw@sina.com
First Name & Middle Initial & Last Name & Degree
C, Doctor
First Name & Middle Initial & Last Name & Degree
Weidong Han
First Name & Middle Initial & Last Name & Degree
Jing Nie
First Name & Middle Initial & Last Name & Degree
Yang Liu
First Name & Middle Initial & Last Name & Degree
Qingming Yang
First Name & Middle Initial & Last Name & Degree
Chunmeng Wang
First Name & Middle Initial & Last Name & Degree
Minhang Zhou
First Name & Middle Initial & Last Name & Degree
Qian Mei
First Name & Middle Initial & Last Name & Degree
Xiang Li
First Name & Middle Initial & Last Name & Degree
Liang Dong
First Name & Middle Initial & Last Name & Degree
Jie Bai

12. IPD Sharing Statement

Learn more about this trial

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

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