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

Phase 1

Recruiting

• Conditions: Non Hodgkin Lymphoma
• Interventions: Drug: Chidamide; Drug: Decitabine; Drug: Camrelizumab

• Registration Number: NCT04337606
• Lead Sponsor: Chinese PLA General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04-04
• Study First Submitted: 2020-04-04
• Study First Submitted QC: 2020-04-04
• Last Update Submitted: 2020-04-04
• Study First Posted: 2020-04-07
• Last Update Posted: 2020-04-07
• Primary Completion: 2024-04-04
• Study Completion: 2026-04-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chidamide in combination with decitabine	Chidamide	chidamide 10mg/day, days 1-5, 20mg/day, day 8, 11,15, 18; decitabine 10 mg/day, days 1-5, every 3 weeks
chidamide in combination with decitabine	Decitabine	chidamide 10mg/day, days 1-5, 20mg/day, day 8, 11,15, 18; decitabine 10 mg/day, days 1-5, every 3 weeks
decitabine in combination with Camrelizumab	Camrelizumab	decitabine 10 mg/day, days 1-5, every 3 weeks; camrelizumab 200mg d6
decitabine in combination with Camrelizumab	Decitabine	decitabine 10 mg/day, days 1-5, every 3 weeks; camrelizumab 200mg d6

Primary Outcome Measures

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

Trial Locations

Locations (1)

Biotherapeutic Department of Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China