Actively Recruiting
Efficacy of Polatuzumab, Bendamustine and Rituximab in Patients With Relapsed/ Refractory Mantle Cell Lymphoma
Led by Medical University of Vienna · Updated on 2024-05-29
16
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Polatuzumab, bendamustine and rituximab in patients with relapsed/ refractory mantle cell lymphoma
CONDITIONS
Official Title
Efficacy of Polatuzumab, Bendamustine and Rituximab in Patients With Relapsed/ Refractory Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand the study and provide written informed consent
- Age 18 years or older
- Histologically or cytologically confirmed relapsed or refractory mantle cell lymphoma
- Previous treatment with at least one chemotherapy regimen including ibrutinib
- If prior bendamustine was received, the response duration was more than 1 year
- At least one measurable lymph node or mass for assessing response
- Life expectancy of at least 24 weeks
- ECOG performance status between 0 and 2
- Adequate blood, kidney, and liver function unless caused by the lymphoma
You will not qualify if you...
- History of severe allergic reactions to monoclonal antibodies or known allergy to bendamustine or rituximab
- Contraindications to polatuzumab, bendamustine, or rituximab
- Use of monoclonal antibodies, radioimmunoconjugates, or antibody-drug conjugates within 4 weeks or 5 half-lives before treatment start
- Use of any investigational drug within 28 days before starting study treatment
- History of other cancers within the last 3 years except certain skin or cervical cancers
- Cancer treatment within 2 weeks before starting the study
- Major surgery or serious injury within 28 days before first study drug dose
- Use of corticosteroids over 30 mg prednisone daily for reasons other than lymphoma symptoms
- Autologous stem cell transplant within 100 days before starting treatment
- Prior allogeneic stem cell transplant
- Eligibility for autologous stem cell transplant
- Primary or secondary central nervous system lymphoma
- Current peripheral neuropathy grade higher than 1
- Significant uncontrolled heart or lung diseases
- Active infections requiring treatment or hospitalization within 4 weeks before treatment
- Suspected or latent tuberculosis
- Positive tests for chronic hepatitis B or hepatitis C
- Known HIV or HTLV-1 infection
- Pregnant or breastfeeding women or those intending pregnancy within a year
- Women unable or unwilling to use effective contraception during the study
- Men unable or unwilling to use effective contraception
- Abnormal kidney, liver, or blood coagulation lab results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AKH Vienna, Division of Oncology Department of Medicine I
Vienna, Austria, 1090
Actively Recruiting
Research Team
B
Barbara Kiesewetter, MD
CONTACT
M
Marika Rosner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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