Status:
RECRUITING
Chidamide in Combination With Decitabine in Non-Hodgkin's Lymphoma Relapsed After Chimeric Antigen Receptor
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Non Hodgkin Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 4 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04337606
Start Date
April 4 2020
End Date
April 4 2026
Last Update
April 7 2020
Active Locations (1)
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1
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853