Treatment for relapsed mantle cell lymphoma using a combination of drugs
Efficacy of Polatuzumab, Bendamustine and Rituximab in Patients With Relapsed/ Refractory Mantle Cell Lymphoma - a Single Center Phase II Trial
This study is testing a new combination of drugs to see if it can help people with relapsed mantle cell lymphoma who haven't had success with other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Drugs / interventions | rituximab, polatuzumab, ibrutinib, chemotherapy, immunotherapy, prednisone |
| Locations | 1 site (Vienna) |
| Trial ID | NCT05868395 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of a combination treatment involving polatuzumab, bendamustine, and rituximab in patients with relapsed or refractory mantle cell lymphoma (MCL). Participants will receive polatuzumab intravenously on specific days of a 21-day cycle, alongside bendamustine and rituximab administered on designated days. The primary endpoint is the response rate measured by RECIST 1.1 criteria, assessing how well the treatment works in shrinking tumors. The study aims to provide a new therapeutic option for patients who have not responded to previous treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed relapsed or refractory mantle cell lymphoma who have previously received at least one treatment regimen including ibrutinib.
Not a fit: Patients with a history of severe allergic reactions to monoclonal antibodies or those with contraindications to the study drugs may not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could offer a new effective option for patients with relapsed or refractory mantle cell lymphoma.
How similar studies have performed: Other studies have shown promising results with similar drug combinations in treating mantle cell lymphoma, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna
- AKH Vienna, Division of Oncology Department of Medicine I — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Barbara Kiesewetter, MD — Medical University Vienna
- Study coordinator: Barbara Kiesewetter, MD
- Email: barbara.kiesewetter@meduniwien.ac.at
- Phone: +43140400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.