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

NCT04897477 | Unknown Phase 1

• 1 other identifier: CHN-PLAGH-BT-066
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

Non-hodgkin Lymphoma,B Cell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Objective Response Rate

  6 month

• Complete Response Rate

  6 month

Study Arms (1)

combination of Azacytidine, Bendamustine and Piamprizumab

EXPERIMENTAL

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

Drug: Azacytidine, Bendamustine and Piamprizumab

Interventions

Azacytidine, Bendamustine and Piamprizumab DRUG

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

combination of Azacytidine, Bendamustine and Piamprizumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (2)

Biotherapeutic Department of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Biotherapeutic Department of Chinese PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

Azacitidine; Bendamustine Hydrochloride

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Butyrates; Acids, Acyclic; Carboxylic Acids; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Weidong Han, M.D.

CONTACT

+861055499341; hanwdrsw@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: April 22, 2021
• Primary Completion: April 23, 2022
• Study Completion: April 23, 2023
• Last Updated: May 21, 2021

Record last verified: 2021-05

Locations

CN (2)