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.

Sponsors

Lead Sponsor: Chinese PLA General Hospital

Source Chinese PLA General Hospital
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.

Overall Status Recruiting
Start Date 2020-08-01
Completion Date 2025-08-01
Primary Completion Date 2022-08-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
ORR assess by investigators per the 2014 Lugano classification 3 years
Number of Subjects with treatment-related adverse events (AEs) 3 years
Enrollment 200
Condition
Intervention

Intervention Type: Drug

Intervention Name: Chidamide; Decitabine; Camrelizumab

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.

Arm Group Label: Chidamide+Decitabine+Camrelizumab

Intervention Type: Drug

Intervention Name: Decitabine+Camrelizumab

Description: Decitabine+Camrelizumab

Arm Group Label: Decitabine+Camrelizumab

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

12 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Weidong Han, M.D.

Phone: +861055499341

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Biotherapeutic Department of Chinese PLA General Hospital Weidong D Han, Doctor +86-10-66937463 [email protected] Weidong Han Principal Investigator Jing Nie Sub-Investigator Yang Liu Sub-Investigator Qingming Yang Sub-Investigator Chunmeng Wang Sub-Investigator Minhang Zhou Sub-Investigator Qian Mei Sub-Investigator Xiang Li Sub-Investigator Liang Dong Sub-Investigator Jie Bai Sub-Investigator
Location Countries

China

Verification Date

2020-08-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Chinese PLA General Hospital

Investigator Full Name: Han weidong

Investigator Title: Professor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Chidamide+Decitabine+Camrelizumab

Type: Experimental

Label: Decitabine+Camrelizumab

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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