Azacytidine, Bendamustine, Piamprizumab in Refractory/Relapsed B-cell Non-Hodgkin's Lymphoma

Non-hodgkin Lymphoma,B Cell Clinical Trial

Official title:

An Open Label, Single Arm, Phase I/II in the Combination of Azacytidine, Bendamustine and Piamprizumab in Refractory/Relapsed B-cell Non-Hodgkin's

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04897477
• Other study ID #: CHN-PLAGH-BT-066
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 22, 2021
• Est. completion date: April 23, 2023

Study information

• Verified date: May 2021
• Source: Chinese PLA General Hospital
• Contact: Weidong Han, M.D.
• Phone: +861055499341
• Email: hanwdrsw[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 23, 2023
• Est. primary completion date: April 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age =18 and =80 years

2. Performance status (ECOG) between 0 and 3.

3. Histologically confirmed B-cell non-Hodgkin lymphoma (NHL), including the following types defined by WHO 2016.

4. 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.

5. Adequate organ function.

6. An adequate bone marrow reserve.

7. 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.

8. Informed consent/assent requiring that all patients have the ability to understand and the willingness to provide written informed consent.

9. Life expectancy > 12 weeks.

10. 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:

1. Pregnant or lactating women.

2. Uncontrolled medical disorders, active bacterial, viral infection or treponema pallidum infection and so on.

3. Requirement for urgent therapy due to tumor mass effects such as respiratory obstruction or blood vessel compression.

4. Current or expected need for systemic corticosteroid therapy.

5. Any organ failure.

6. Patients with a second tumor requiring therapy or intervention.

7. 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.

8. Prior organ allograft.

9. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Non-hodgkin Lymphoma,B Cell

Intervention

Drug:
• Azacytidine, Bendamustine and Piamprizumab
Azacytidine by means of subcutaneous injection, Bendamustine and Piamprizumab intravenous infusion

Locations

Country	Name	City	State
China	Biotherapeutic Department of Chinese PLA General Hospital	Beijing	Beijing
China	Biotherapeutic Department of Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: treatment-related adverse events (AEs)	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.	6 month
Secondary	Objective Response Rate	The ORR is defined as the proportion of patients with a best overall disease response, including complete response (CR) and partial response (PR).	6 month
Secondary	Complete Response Rate	CR rate assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects	6 month