Azacytidine, Bendamustine, Piamprizumab in Refractory/Relapsed B-cell Non-Hodgkin's Lymphoma
Study Details
Study Description
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 Piamprizumab
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: combination of Azacytidine, Bendamustine and Piamprizumab combination of Azacytidine, Bendamustine and Piamprizumab in Refractory/Relapsed B-cell Non-Hodgkin's Lymphoma, every 28 days |
Drug: Azacytidine, Bendamustine and Piamprizumab
Azacytidine by means of subcutaneous injection, Bendamustine and Piamprizumab intravenous infusion
|
Outcome Measures
Primary Outcome Measures
- Safety: treatment-related adverse events (AEs) [6 month]
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit.
Secondary Outcome Measures
- Objective Response Rate [6 month]
The ORR is defined as the proportion of patients with a best overall disease response, including complete response (CR) and partial response (PR).
- Complete Response Rate [6 month]
CR rate assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
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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.
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Adequate organ function.
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An adequate bone marrow reserve.
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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.
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Informed consent/assent requiring that all patients have the ability to understand and the willingness to provide written informed consent.
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Life expectancy > 12 weeks.
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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 Criteria:
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Pregnant or lactating women.
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Uncontrolled medical disorders, active bacterial, viral infection or treponema pallidum infection and so on.
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Requirement for urgent therapy due to tumor mass effects such as respiratory obstruction or blood vessel compression.
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Current or expected need for systemic corticosteroid therapy.
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Any organ failure.
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Patients with a second tumor requiring therapy or intervention.
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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.
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Prior organ allograft.
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Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Biotherapeutic Department of Chinese PLA General Hospital | Beijing | Beijing | China | 100853 |
2 | Biotherapeutic Department of Chinese PLA General Hospital | Beijing | China |
Sponsors and Collaborators
- Chinese PLA General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHN-PLAGH-BT-066