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

May 18, 2021 updated by: Han weidong, Chinese PLA General Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Biotherapeutic Department of Chinese PLA General Hospital
        • Contact:
          • Weidong Han, M.D
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Biotherapeutic Department of Chinese PLA General Hospital
        • Sub-Investigator:
          • Yajing Zhang
        • Sub-Investigator:
          • Zhiqiang Wu
        • Sub-Investigator:
          • Yao Wang
        • Sub-Investigator:
          • Chuan Tong
        • Sub-Investigator:
          • Jing Nie
        • Contact:
        • Sub-Investigator:
          • Fengxia Shi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: treatment-related adverse events (AEs)
Time Frame: 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.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: 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).
6 month
Complete Response Rate
Time Frame: 6 month
CR rate assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2021

Primary Completion (Anticipated)

April 23, 2022

Study Completion (Anticipated)

April 23, 2023

Study Registration Dates

First Submitted

May 18, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (Actual)

May 21, 2021

Study Record Updates

Last Update Posted (Actual)

May 21, 2021

Last Update Submitted That Met QC Criteria

May 18, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHN-PLAGH-BT-066

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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