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Efficacy of Polatuzumab, Bendamustine and Rituximab in Patients With Relapsed/ Refractory Mantle Cell Lymphoma

Primary Purpose

Mantle-cell Lymphoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Polatuzumab, bendamustin und rituximab
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle-cell Lymphoma

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Capability of understanding the purpose of the study and have given written informed consent. Age greater than or equal to 18 years Histologically or cytologically confirmed relapsed or refractory MCL r/r MCL patients following standard first line chemotherapy who have received at least one prior regimen including ibrutinib If the participant has received prior bendamustine, response duration must have been > 1 year Presence of at least one lymph node or mass measurable for response Life expectancy of at least 24 weeks ECOG 0-2 Adequate hematological, renal and hepatic function unless inadequate function is due to underlying disease Exclusion Criteria: History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (MAbs or recombinant antibody-related fusion proteins) or known sensitivity or allergy to bendamustine or rituximab Contraindications to polatuzumab, bendamustine or rituximab Prior use of any MAb, radioimmunoconjugate, or antibody-drug conjugate (ADC) within 4 weeks or 5 half-lives before cycle 1 day 1 Use of any investigational agent within 28 days prior to initiation of study treatment History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 3 years Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to cycle 1 day Major surgery or significant traumatic injury within 28 days of the first dose of study drug Ongoing corticosteroid use >30 mg per day prednisone or equivalent, for purposes other than lymphoma symptom control Autologous stem cell transplant (SCT) within 100 days prior to cycle 1 day 1 Prior allogeneic SCT Eligibility for autologous SCT Primary or secondary CNS lymphoma Current grade >1 peripheral neuropathy Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm) Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to Cycle 1 Day 1 Suspected or latent tuberculosis Positive test results for chronic hepatitis B virus (HBV) infection or for hepatitis C virus (HCV) antibody Known history of human immunodeficiency virus (HIV) seropositive status or known infection with human T-cell leukemia virus 1 (HTLV-1) virus Women who are pregnant or lactating or who intend to become pregnant within a year of the last dose of study treatment. Women of childbearing potential must have a negative pregnancy test at screening, pregnancy testing must be performed within 7 days before first administration of IMP. Approved methods of birth control must be used Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to the last dose of protocol therapy. Adequate contraception defined as hormonal birth control, intrauterine device, double barrier method or total abstinence. Male subjects unable or unwilling to use adequate contraception methods. Evidence of laboratory abnormalities in standard renal, hepatic, or coagulation function tests

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Polatuzumab, bendamustine and rituximab

    Arm Description

    Polatuzumab vedotin 1.8 mg/kg i.v. on day 2 of cycle 1, then on day 1 of each subsequent cycle, bendamustine 90 mg/m2 i.v. day 2 & 3 of cycle 1, then on day 1 & 2 of each subsequent cycle and rituximab 375 mg/m2 i.v. on day 1 of each cycle every 3 weeks.

    Outcomes

    Primary Outcome Measures

    Objective response rate
    Objective response rate according to RECIST 1.1

    Secondary Outcome Measures

    Survival
    Progression-free survival (PFS), Event-free survival (EFS), Overall survival (OS)
    Safety / Toxicity
    Safety / Toxicity according to Adverse Events

    Full Information

    First Posted
    May 11, 2023
    Last Updated
    May 11, 2023
    Sponsor
    Medical University of Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05868395
    Brief Title
    Efficacy of Polatuzumab, Bendamustine and Rituximab in Patients With Relapsed/ Refractory Mantle Cell Lymphoma
    Official Title
    Efficacy of Polatuzumab, Bendamustine and Rituximab in Patients With Relapsed/ Refractory Mantle Cell Lymphoma - a Single Center Phase II Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 24, 2023 (Anticipated)
    Primary Completion Date
    May 24, 2027 (Anticipated)
    Study Completion Date
    May 24, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Vienna

    4. Oversight

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

    5. Study Description

    Brief Summary
    Polatuzumab, bendamustine and rituximab in patients with relapsed/ refractory mantle cell lymphoma
    Detailed Description
    Polatuzumab vedotin will be administered at a dose of 1.8 mg/kg i.v. on day 2 of cycle 1, then on day 1 of each subsequent cycle. Bendamustine will be administered at a dose 90 mg/m2 i.v. day 2 & 3 of cycle 1, then on day 1 & 2 of each subsequent cycle. Rituximab will be administered at a dose 375 mg/m2 i.v. on day 1 of each cycle. Each cycle is 21 days long Response rate by RECIST 1.1 is definied as the primary study endpoint.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mantle-cell Lymphoma

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Polatuzumab, bendamustine and rituximab
    Arm Type
    Experimental
    Arm Description
    Polatuzumab vedotin 1.8 mg/kg i.v. on day 2 of cycle 1, then on day 1 of each subsequent cycle, bendamustine 90 mg/m2 i.v. day 2 & 3 of cycle 1, then on day 1 & 2 of each subsequent cycle and rituximab 375 mg/m2 i.v. on day 1 of each cycle every 3 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Polatuzumab, bendamustin und rituximab
    Other Intervention Name(s)
    Polivy, Bendamustin, Mabthera
    Intervention Description
    Polatuzumab vedotin 1.8 mg/kg i.v. on day 2 of cycle 1, then on day 1 of each subsequent cycle Bendamustine 90 mg/m2 i.v. day 2 & 3 of cycle 1, then on day 1 & 2 of each subsequent cycle Rituximab 375 mg/m2 i.v. on day 1 of each cycle Each cycle is 21 days long Up to 6 cycles per patients planned
    Primary Outcome Measure Information:
    Title
    Objective response rate
    Description
    Objective response rate according to RECIST 1.1
    Time Frame
    From date of enrollment until the date of first documented progression or date of death from any cause or treatmentdiscontinuation from any other reason, whichever came first, assessedup to 36 months]
    Secondary Outcome Measure Information:
    Title
    Survival
    Description
    Progression-free survival (PFS), Event-free survival (EFS), Overall survival (OS)
    Time Frame
    From date of inclusion until the date of first documented progression or date of death from any cause or treatmentdiscontinuation from any other reason, whichever came first, assessedup to 36 months]
    Title
    Safety / Toxicity
    Description
    Safety / Toxicity according to Adverse Events
    Time Frame
    From date of inclusion until the date of first documented progression or date of death from any cause or treatmentdiscontinuation from any other reason, whichever came first, assessedup to 36 months]

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Capability of understanding the purpose of the study and have given written informed consent. Age greater than or equal to 18 years Histologically or cytologically confirmed relapsed or refractory MCL r/r MCL patients following standard first line chemotherapy who have received at least one prior regimen including ibrutinib If the participant has received prior bendamustine, response duration must have been > 1 year Presence of at least one lymph node or mass measurable for response Life expectancy of at least 24 weeks ECOG 0-2 Adequate hematological, renal and hepatic function unless inadequate function is due to underlying disease Exclusion Criteria: History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (MAbs or recombinant antibody-related fusion proteins) or known sensitivity or allergy to bendamustine or rituximab Contraindications to polatuzumab, bendamustine or rituximab Prior use of any MAb, radioimmunoconjugate, or antibody-drug conjugate (ADC) within 4 weeks or 5 half-lives before cycle 1 day 1 Use of any investigational agent within 28 days prior to initiation of study treatment History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 3 years Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to cycle 1 day Major surgery or significant traumatic injury within 28 days of the first dose of study drug Ongoing corticosteroid use >30 mg per day prednisone or equivalent, for purposes other than lymphoma symptom control Autologous stem cell transplant (SCT) within 100 days prior to cycle 1 day 1 Prior allogeneic SCT Eligibility for autologous SCT Primary or secondary CNS lymphoma Current grade >1 peripheral neuropathy Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm) Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to Cycle 1 Day 1 Suspected or latent tuberculosis Positive test results for chronic hepatitis B virus (HBV) infection or for hepatitis C virus (HCV) antibody Known history of human immunodeficiency virus (HIV) seropositive status or known infection with human T-cell leukemia virus 1 (HTLV-1) virus Women who are pregnant or lactating or who intend to become pregnant within a year of the last dose of study treatment. Women of childbearing potential must have a negative pregnancy test at screening, pregnancy testing must be performed within 7 days before first administration of IMP. Approved methods of birth control must be used Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to the last dose of protocol therapy. Adequate contraception defined as hormonal birth control, intrauterine device, double barrier method or total abstinence. Male subjects unable or unwilling to use adequate contraception methods. Evidence of laboratory abnormalities in standard renal, hepatic, or coagulation function tests
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Barbara Kiesewetter, MD
    Phone
    +43140400
    Ext
    44450
    Email
    barbara.kiesewetter@meduniwien.ac.at
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marika Rosner
    Phone
    +43140400
    Ext
    44450
    Email
    marika.rosner@meduniwien.ac.at
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Barbara Kiesewetter, MD
    Organizational Affiliation
    Medical University Vienna
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Polatuzumab, Bendamustine and Rituximab in Patients With Relapsed/ Refractory Mantle Cell Lymphoma

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