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

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04897477
Collaborator
(none)
30
2
1
24
15
0.6

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
  • Drug: Azacytidine, Bendamustine and Piamprizumab
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 22, 2021
Anticipated Primary Completion Date :
Apr 23, 2022
Anticipated Study Completion Date :
Apr 23, 2023

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

  1. 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

  1. 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).

  2. 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

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

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.
Responsible Party:
Han weidong, Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT04897477
Other Study ID Numbers:
  • CHN-PLAGH-BT-066
First Posted:
May 21, 2021
Last Update Posted:
May 21, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 21, 2021