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

Mantle-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868395
• Other study ID #: Polatuzumab-BR in r/r MCL
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2, 2024
• Est. completion date: May 24, 2027

Study information

• Verified date: May 2024
• Source: Medical University of Vienna
• Contact: Barbara Kiesewetter, MD
• Phone: +43140400
• Email: barbara.kiesewetter[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: May 24, 2027
• Est. primary completion date: May 24, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle-cell Lymphoma

Intervention

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

Locations

Country	Name	City	State
Austria	AKH Vienna, Division of Oncology Department of Medicine I	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	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	Survival	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]
Secondary	Safety / Toxicity	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]