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

Who is this study for? Adult patients with Non-Hodgkin's lymphomas
What treatments are being studied? Chidamide+Decitabine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Biotherapeutic Department of Chinese PLA General Hospital
RECRUITING
Beijing
Time Frame
Start Date: 2020-04-04
Estimated Completion Date: 2026-04-04
Participants
Target number of participants: 100
Treatments
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
Experimental: decitabine in combination with Camrelizumab
decitabine 10 mg/day, days 1-5, every 3 weeks; camrelizumab 200mg d6
Related Therapeutic Areas
Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Sponsors
Leads: Chinese PLA General Hospital

This content was sourced from clinicaltrials.gov

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