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Tests treatment safety and results for Mantle-cell Lymphoma
Official title Efficacy of Polatuzumab, Bendamustine and Rituximab in Patients With Relapsed/ Refractory Mantle Cell Lymphoma
ClinicalTrials.gov ID: NCT05868395
What this study is testing
What is Polatuzumab, bendamustin und rituximab?
Polatuzumab, bendamustin und rituximab is an investigational medicine, being studied as a potential treatment for mantle-cell lymphoma.
Also referred to as Polivy, Bendamustin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Polatuzumab, bendamustine and rituximab in patients with relapsed/ refractory mantle cell lymphoma
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join 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
You likely can't join if
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (MAbs or recombinant antibody-related fusion...
- 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...
See the full eligibility 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
- 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...
- 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...
- 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...
- 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...
- Male people unable or unwilling to use adequate contraception methods.
- Evidence of laboratory abnormalities in standard renal, hepatic, or coagulation function tests
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.