Status:
UNKNOWN
Azacytidine, Bendamustine, Piamprizumab in Refractory/Relapsed B-cell Non-Hodgkin's Lymphoma
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Non-hodgkin Lymphoma,B Cell
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open label, single arm, phase I/II for patients with r/r Non-Hodgkin's Lymphoma . The purpose is to evaluate the safety and efficacy of the combination with Azacytidine, Bendamustine and P...
Eligibility Criteria
Inclusion
- Age ≥18 and ≤80 years
- Performance status (ECOG) between 0 and 3.
- Histologically confirmed B-cell non-Hodgkin lymphoma (NHL), including the following types defined by WHO 2016.
- Refractory disease or relapsed after treatment with ≥2 lines of chemotherapy and either having failed autologous HSCT or being ineligible for or not consenting to autologous HSCT; or not suitable for CAR T treatment or resistance, progression or relapse after CAR T treatment; or CAR T pre-culturing losers can also be enrolled.
- Adequate organ function.
- An adequate bone marrow reserve.
- Measurable or assessable disease according to the"IWG Response Criteria for Malignant Lymphoma"(Cheson 2014). Patients in complete remission (CR) with no evidence of disease were not eligible.
- Informed consent/assent requiring that all patients have the ability to understand and the willingness to provide written informed consent.
- Life expectancy \> 12 weeks.
- Patients with definite involvement of the gastrointestinal tract, and patients with central nervous system (CNS) by PETCT and MRI involvement were allowed to enrolled in this clinical study.
Exclusion
- Pregnant or lactating women.
- Uncontrolled medical disorders, active bacterial, viral infection or treponema pallidum infection and so on.
- Requirement for urgent therapy due to tumor mass effects such as respiratory obstruction or blood vessel compression.
- Current or expected need for systemic corticosteroid therapy.
- Any organ failure.
- Patients with a second tumor requiring therapy or intervention.
- Subjects considered unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation according to the investigator's judgement.
- Prior organ allograft.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 23 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04897477
Start Date
April 22 2021
End Date
April 23 2023
Last Update
May 21 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
2
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, China