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

May 27, 2024 updated by: Barbara Kiesewetter, Medical University of Vienna

Efficacy of Polatuzumab, Bendamustine and Rituximab in Patients With Relapsed/ Refractory Mantle Cell Lymphoma - a Single Center Phase II Trial

Polatuzumab, bendamustine and rituximab in patients with relapsed/ refractory mantle cell lymphoma

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Phase 2

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 Contact Backup

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: Polatuzumab, bendamustine and rituximab
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.
Drug: Polatuzumab, bendamustin und rituximab
  • 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
Other Names:
  • Mabthera
  • Polivy
  • Bendamustin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
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]
Objective response rate according to RECIST 1.1
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 Measures

Outcome Measure
Measure Description
Time Frame
Survival
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]
Progression-free survival (PFS), Event-free survival (EFS), Overall survival (OS)
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]
Safety / Toxicity
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]
Safety / Toxicity according to Adverse Events
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]

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Barbara Kiesewetter, MD, Medical University Vienna

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)

January 2, 2024

Primary Completion (Estimated)

May 24, 2027

Study Completion (Estimated)

May 24, 2027

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

May 11, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 27, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Polatuzumab-BR in r/r MCL

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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