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

• Sponsor: Chinese PLA General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04337606
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non Hodgkin Lymphoma	Drug: Chidamide; Drug: Decitabine; Drug: Camrelizumab	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Chidamide in Combination With Decitabine in Non-Hodgkin's Lymphoma Relapsed After Chimeric Antigen Receptor : An Open-label Phase I/II Trial
• Anticipated Study Start Date: Apr 4, 2020
• Anticipated Primary Completion Date: Apr 4, 2024
• Anticipated Study Completion Date: Apr 4, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: chidamide in combination with decitabine chidamide 10mg/day, days 1-5, 20mg/day, day 8, 11,15, 18; decitabine 10 mg/day, days 1-5, every 3 weeks	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.; Drug: 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.
Experimental: decitabine in combination with Camrelizumab decitabine 10 mg/day, days 1-5, every 3 weeks; camrelizumab 200mg d6	Drug: 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.; Drug: Camrelizumab; Camrelizumab is a humanized anti-PD-1 monoclonal antibody.

Outcome Measures

Primary Outcome Measures

1. CR rate [2 years]

   CR rate assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects

2. Adverse events [2 years]

   Adverse events were defined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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, Principal Investigator, Chinese PLA General Hospital
• ClinicalTrials.gov Identifier: NCT04337606
• Other Study ID Numbers: CHN-PLAGH-BT-046
• First Posted: Apr 7, 2020
• Last Update Posted: Apr 7, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Decitabine

Study Results

No Results Posted as of Apr 7, 2020