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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Non Hodgkin Lymphoma

Treatments: Drug: Chidamide; Drug: Camrelizumab; Drug: Decitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT04337606

CHN-PLAGH-BT-046

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

chidamide in combination with decitabine

Experimental group

Description:

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

Treatment:

Drug: Decitabine

Drug: Chidamide

decitabine in combination with Camrelizumab

Experimental group

Description:

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

Treatment:

Drug: Decitabine

Drug: Camrelizumab