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

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

NCT ID: NCT05868395

Condition: Mantle-cell Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, Mantle-Cell
Rituximab
Bendamustine Hydrochloride

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Polatuzumab, bendamustin und rituximab
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
Arm group label: Polatuzumab, bendamustine and rituximab

Other name: Polivy

Other name: Bendamustin

Other name: Mabthera

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: No

Locations:

Facility:
Name: AKH Vienna, Division of Oncology Department of Medicine I

Address:
City: Vienna
Zip: 1090
Country: Austria

Status: Recruiting

Contact:
Last name: Barbara Kiesewetter-Wiederkehr, MD

Phone: +43140400

Phone ext: 44450
Email: barbara.kiesewetter@meduniwien.ac.at

Contact backup:
Last name: Marika Rosner

Phone: +43140400

Phone ext: 44450
Email: marika.rosner@meduniwien.ac.at

Start date: January 2, 2024

Completion date: May 24, 2027

Lead sponsor:
Agency: Medical University of Vienna
Agency class: Other

Source: Medical University of Vienna

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05868395