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

Sponsor

Chinese PLA General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04514081

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Lymphoma Anti-PD-1 Antibody Resistant	Drug: Chidamide; Decitabine; Camrelizumab Drug: Decitabine+Camrelizumab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Biotherapeutic Department of Chinese PLA General Hospital	Beijing	Beijing	China	100853

Sponsors and Collaborators

Chinese PLA General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Han weidong, Professor, Chinese PLA General Hospital

ClinicalTrials.gov Identifier:

NCT04514081

Other Study ID Numbers:

CHN-PLAGH-BT-057

First Posted:

Aug 14, 2020

Last Update Posted:

Aug 18, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lymphoma

Hodgkin Disease

Decitabine

Study Results

No Results Posted as of Aug 18, 2020