Chidamide in Combination With Decitabine in Non-Hodgkin's Lymphoma Relapsed After Chimeric Antigen Receptor

Non Hodgkin Lymphoma Clinical Trial

Official title:

Chidamide in Combination With Decitabine in Non-Hodgkin's Lymphoma Relapsed After Chimeric Antigen Receptor : An Open-label Phase I/II Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04337606
• Other study ID #: CHN-PLAGH-BT-046
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 4, 2020
• Est. completion date: April 4, 2026

Study information

• Verified date: April 2020
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase I/II clinical trial for patients with r/r Non-Hodgkin's Lymphoma relapsed after chimeric antigen receptor T cells infusion. The purpose is to evaluate the safety and efficacy of the treatment with chidamide in combination with decitabine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 4, 2026
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Subjects must have histological confirmation of Non-Hodgkin lymphoma (NHL) and relapsed after chimeric antigen receptor T cells infusion.

2. 18 to 65 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 new lesion >1.5cm as defined by lymphoma response criteria.

6. Subjects must have relapsed after chimeric antigen receptor T cells infusion without any intervention treatment prior to Day 1.

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 one 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 (eg, infectious disease) illness

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non Hodgkin Lymphoma

Intervention

Drug:
• Chidamide
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.
• 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
Camrelizumab is a humanized anti-PD-1 monoclonal antibody.

Locations

Country	Name	City	State
China	Biotherapeutic Department of Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CR rate	CR rate assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects	2 years
Primary	Adverse events	Adverse events were defined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0)	2 years