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

Primary Purpose

Non-hodgkin Lymphoma,B Cell

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Azacytidine, Bendamustine and Piamprizumab
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-hodgkin Lymphoma,B Cell

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Biotherapeutic Department of Chinese PLA General HospitalRecruiting
  • Biotherapeutic Department of Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

combination of Azacytidine, Bendamustine and Piamprizumab

Arm Description

combination of Azacytidine, Bendamustine and Piamprizumab in Refractory/Relapsed B-cell Non-Hodgkin's Lymphoma, every 28 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Complete Response Rate
CR rate assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects

Full Information

First Posted
May 18, 2021
Last Updated
May 18, 2021
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04897477
Brief Title
Azacytidine, Bendamustine, Piamprizumab in Refractory/Relapsed B-cell Non-Hodgkin's Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
April 23, 2022 (Anticipated)
Study Completion Date
April 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-hodgkin Lymphoma,B Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
combination of Azacytidine, Bendamustine and Piamprizumab
Arm Type
Experimental
Arm Description
combination of Azacytidine, Bendamustine and Piamprizumab in Refractory/Relapsed B-cell Non-Hodgkin's Lymphoma, every 28 days
Intervention Type
Drug
Intervention Name(s)
Azacytidine, Bendamustine and Piamprizumab
Intervention Description
Azacytidine by means of subcutaneous injection, Bendamustine and Piamprizumab intravenous infusion
Primary Outcome Measure Information:
Title
Safety: treatment-related adverse events (AEs)
Description
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.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
The ORR is defined as the proportion of patients with a best overall disease response, including complete response (CR) and partial response (PR).
Time Frame
6 month
Title
Complete Response Rate
Description
CR rate assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weidong Han, M.D.
Phone
+861055499341
Email
hanwdrsw@sina.com
Facility Information:
Facility Name
Biotherapeutic Department of Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong D Han, M.D.
Phone
+86-10-66937463
Email
hanwdrsw69@yahoo.com
First Name & Middle Initial & Last Name & Degree
C
First Name & Middle Initial & Last Name & Degree
Weidong Han
First Name & Middle Initial & Last Name & Degree
Yajing Zhang
First Name & Middle Initial & Last Name & Degree
Yang Liu
First Name & Middle Initial & Last Name & Degree
Qingming Yang
First Name & Middle Initial & Last Name & Degree
Jing Nie
First Name & Middle Initial & Last Name & Degree
Yao Wang
First Name & Middle Initial & Last Name & Degree
Zhiqiang Wu
First Name & Middle Initial & Last Name & Degree
Chuan Tong
First Name & Middle Initial & Last Name & Degree
Miaomiao Bai
First Name & Middle Initial & Last Name & Degree
Fengxia Shi
Facility Name
Biotherapeutic Department of Chinese PLA General Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Han, M.D

12. IPD Sharing Statement

Learn more about this trial

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

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