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

NCT05868395 | Recruiting Phase 2

• 1 other identifier: Polatuzumab-BR in r/r MCL
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mantle-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Survival

  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

  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]

Study Arms (1)

Polatuzumab, bendamustine and rituximab

EXPERIMENTAL

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

Interventions

Polatuzumab, bendamustin und rituximab DRUG

* 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

Also known as: Polivy, Bendamustin, Mabthera

Polatuzumab, bendamustine and rituximab

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

AKH Vienna, Division of Oncology Department of Medicine I

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

polatuzumab vedotin; Bendamustine Hydrochloride; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Barbara Kiesewetter, MD

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Kiesewetter, MD

CONTACT

+43140400; barbara.kiesewetter@meduniwien.ac.at

Marika Rosner

CONTACT

+43140400; marika.rosner@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ap. Prof. Priv.-Doz. DDr

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: January 2, 2024
• Primary Completion (Estimated): May 24, 2027
• Study Completion (Estimated): May 24, 2027
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

AU (1)