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

Primary Purpose

Non Hodgkin Lymphoma

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Chidamide

Decitabine

Camrelizumab

About this trial

This is an interventional treatment trial for Non Hodgkin Lymphoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects must have histological confirmation of Non-Hodgkin lymphoma (NHL) and relapsed after chimeric antigen receptor T cells infusion.
18 to 65 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 new lesion >1.5cm as defined by lymphoma response criteria.
Subjects must have relapsed after chimeric antigen receptor T cells infusion without any intervention treatment prior to Day 1.
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 one 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 (eg, infectious disease) illness

Sites / Locations

Biotherapeutic Department of Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

chidamide in combination with decitabine

decitabine in combination with Camrelizumab

Arm Description

chidamide 10mg/day, days 1-5, 20mg/day, day 8, 11,15, 18; decitabine 10 mg/day, days 1-5, every 3 weeks

decitabine 10 mg/day, days 1-5, every 3 weeks; camrelizumab 200mg d6

Outcomes

Primary Outcome Measures

CR rate

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

Adverse events

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04337606

First Posted

April 4, 2020

Last Updated

April 4, 2020

Sponsor

Chinese PLA General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04337606

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Recruiting

Study Start Date

April 4, 2020 (Anticipated)

Primary Completion Date

April 4, 2024 (Anticipated)

Study Completion Date

April 4, 2026 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Hodgkin Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

chidamide in combination with decitabine

Arm Type

Experimental

Arm Description

chidamide 10mg/day, days 1-5, 20mg/day, day 8, 11,15, 18; decitabine 10 mg/day, days 1-5, every 3 weeks

Arm Title

decitabine in combination with Camrelizumab

Arm Type

Experimental

Arm Description

decitabine 10 mg/day, days 1-5, every 3 weeks; camrelizumab 200mg d6

Intervention Type

Drug

Intervention Name(s)

Chidamide

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.

Intervention Type

Drug

Intervention Name(s)

Decitabine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Camrelizumab

Intervention Description

Camrelizumab is a humanized anti-PD-1 monoclonal antibody.

Primary Outcome Measure Information:

Title

CR rate

Description

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

Time Frame

2 years

Title

Adverse events

Description

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must have histological confirmation of Non-Hodgkin lymphoma (NHL) and relapsed after chimeric antigen receptor T cells infusion. 18 to 65 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 new lesion >1.5cm as defined by lymphoma response criteria. Subjects must have relapsed after chimeric antigen receptor T cells infusion without any intervention treatment prior to Day 1. 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 one 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 (eg, infectious disease) illness

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: