Mantle-cell LymphomaPhase 2NCT05868395
Efficacy of Polatuzumab, Bendamustine and Rituximab in Patients With Relapsed/ Refractory Mantle Cell Lymphoma
A Phase 2 study testing Polatuzumab, bendamustin und rituximab in people with Mantle-cell Lymphoma, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Polatuzumab, bendamustine and rituximab in patients with relapsed/ refractory mantle cell lymphoma Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Mantle-cell Lymphoma
- What is being tested?
- Polatuzumab, bendamustin und rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustria
- Study dates
- 2 Jan 2024to 24 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Life expectancy of at least 24 weeks
- ECOG 0-2
- Adequate hematological, renal and hepatic function unless inadequate function is due to underlying disease
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
AKH Vienna, Division of Oncology Department of Medicine I
Vienna, 1090
Barbara Kiesewetter-Wiederkehr, MD, +43140400 ext. 44450, barbara.kiesewetter@meduniwien.ac.at
Marika Rosner, +43140400 ext. 44450, marika.rosner@meduniwien.ac.at
About this study
Official title: Efficacy of Polatuzumab, Bendamustine and Rituximab in Patients With Relapsed/ Refractory Mantle Cell Lymphoma - a Single Center Phase II Trial
Polatuzumab, bendamustine and rituximab in patients with relapsed/ refractory mantle cell lymphoma
Read the detailed 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.
- Conditions
- Mantle-cell Lymphoma
- Being tested
- Polatuzumab, bendamustin und rituximab
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polatuzumab, bendamustin und rituximabDrug
Also called Polivy, Bendamustin, Mabthera
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Polatuzumab, bendamustin und rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate according to RECIST 1.1
Measured: 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
Progression-free survival (PFS), Event-free survival (EFS), Overall survival (OS)
Measured: 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
Safety / Toxicity according to Adverse Events
Measured: 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]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start2 Jan 2024
- Primary completion24 May 2027 (estimated)
- Study completion24 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Kiesewetter, Medical University of Vienna
- Investigators
- Barbara Kiesewetter, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868395
- Sponsor's protocol ID
- Polatuzumab-BR in r/r MCL
- Status last verified
- May 2024
- First submitted
- 11 May 2023
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Polatuzumab, Bendamustine and Rituximab in Patients With Relapsed/ Refractory Mantle Cell Lymphoma - a Single Center Phase II Trial
- ClinicalTrials.gov ID
- NCT05868395
- Acronym / sponsor ID
- Polatuzumab-BR in r/r MCL
- Conditions
- Mantle-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 24 May 2027 (estimated)
- Study completion
- 24 May 2027 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Polatuzumab, bendamustine and rituximab in patients with relapsed/ refractory mantle cell lymphoma
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polatuzumab, bendamustine and rituximab | Experimental | Drug: Polatuzumab, bendamustin und rituximabPolatuzumab 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polatuzumab, bendamustin und rituximabAlso: Polivy, Bendamustin, Mabthera* 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 | Drug | Polatuzumab, bendamustine and rituximab |
Primary outcome
Objective response rate
Time frame: 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]
Objective response rate according to RECIST 1.1
2 secondary outcomes
Survival
Time frame: 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
Time frame: 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]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barbara Kiesewetter, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polatuzumab, bendamustin und rituximab in people with Mantle-cell Lymphoma, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Kiesewetter, MD (+43140400 ext. 44450, barbara.kiesewetter@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.