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Lymphoma, Large B-Cell, DiffusePhase 2R-Pola-GloNCT05798156

Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive B-cell Lymphoma Ineligible for R-CHOP

A Phase 2 study testing Glofitamab, Rituximab and Obinutuzumab in people with Lymphoma, Large B-Cell, Diffuse, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 28 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

In the present trial the chemotherapy- light treatment concept R-Pola-Glo will be evaluated that combines the anti-CD20 antibody rituximab (R) with the ADC polatuzumab vedotin (Pola) and the (BiMabs) glofitamab (Glo) in elderly and/or medical unfit and previously untreated patients with aggressive B-cell lymphoma. Read more about this study

Who is it for?
Ages 61 years and older
Conditions the study is for
Lymphoma, Large B-Cell, Diffuse
What is being tested?
Glofitamab, Rituximab and Obinutuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
28 sitesin 2 countries
Study dates
20 Mar 2023to 28 Feb 2028
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 61 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient has provided written informed consent and is able and willing to comply with the study protocol and protocol mandated treatments according to ICH and local regulations.
  • Patient is above 60 years of age
  • Patient is not eligible for a fully dosed R-CHOP
  • Patient has histologically confirmed aggressive B-cell lymphoma.
  • Patient has at least one measurable FDG PET-positive lymphoma manifestation; defined as lesional maximum FDG uptake higher than the maximum FDG uptake in unaffected liver parenchyma as measured in a reference volume-of-interest with >10 mL
  • Baseline biopsy material is available for central review.
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  • Female patients considered as women of childbearing potential (WOCBP, see section 5.2.7 for definition) and male patients with female partners considered as WOCBP must:
  • agree to either remain completely abstinent (refrain from heterosexual intercourse) or to use at least one effective contraceptive methods that results in a failure rate of < 1% per year
  • refrain from donating ova (female patients) or donating sperm (male patients)
  • in case of male patients with pregnant female partners, remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures such as a condom to avoid exposing the embryo.
  • Patient did not receive any prior systemic lymphoma therapy.
  • Patient has an ECOG performance status of ≤ 2.
  • Patient has with treatment a life expectancy (in the opinion of the investigator) of at least 12 weeks.
  • Patient has adequate liver function
  • Patient as adequate hematological function
  • Patient has adequate renal function
  • Patients has negative serologic and/or polymerase chain reaction (PCR) test results for:
  • Acute or chronic hepatitis B (HBV) infection.
  • Hepatis C virus (HCV) and human immunodeficiency virus (HIV)
  • Patient has no active SARS-CoV-2 infection.

Who cannot join

  • Medical conditions:
  • Patient with chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL) (including CD20+ ALL), lymphoblastic lymphoma, Richter's transformation, Burkitt lymphoma.
  • Patient ≤ 60 years
  • Patient with known active infection, or reactivation of a latent infection, whether bacterial (e.g., tuberculosis), viral (including, but not limited to severe pneumonia, COVID-19, Epstein-Barr virus [EBV], cytomegalovirus [CMV], hepatitis B, hepatitis C, and HIV], fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks prior to study enrollment.
  • Patient with current > Grade 1 peripheral neuropathy.
  • Patient with history of confirmed progressive multifocal leukoencephalopathy (PML).
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  • Patient with history of leptomeningeal disease.
  • Patient with current or history of CNS lymphoma.
  • Patient with current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease with exceptions.
  • Patient with another invasive malignancy in the last 2 years (with the exception of basal cell carcinoma and tumors deemed by the Investigator to be of low likelihood for recurrence), with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate 90%), such as adequately-treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
  • Patient with significant or extensive history of cardiovascular disease (such as New York Heart Association (NYHA) Class ≥ II cardiac disease, congestive heart failure, myocardial infarction or cerebrovascular accident within the past 3 months, unstable arrhythmias, or unstable angina or history of multiple cardiovascular events) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm).
  • Patient with active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis (see addendum for a more comprehensive list of autoimmune diseases and immune deficiencies), with exceptions.
  • Patient with uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
  • Patient with history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic.
  • Prior/Concomitant Therapy:
  • Patient received treatment with any other standard anti-cancer radiotherapy/chemotherapy including investigational therapy (defined as treatment for which there is currently no regulatory authority approved indication) within 4 weeks or five times the elimination half-life of the product, whichever is longer, prior to study enrollment.
  • Patient with prior solid organ transplantation.
  • Patient with prior allogeneic stem cell transplantation.
  • Patient with prior treatment with targeted therapies (e.g., tyrosine kinase inhibitors, systemic immunotherapeutic/immunostimulating agents, including, but not limited to, CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, radio-immunoconjugates, antibody-drug conjugates, immune/cytokines, and monoclonal antibodies) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to study enrollment.
  • Patient with toxicities from prior anti-cancer therapy including immunotherapy that did not resolve to ≤ Grade 1 except for alopecia, endocrinopathy managed with replacement therapy and stable vitiligo.
  • Patient with any history of immune related ≥ Grade 3 AE except for endocrinopathy managed with replacement therapy.
  • Patient with ongoing corticosteroid use 25 mg/day of prednisone or equivalent within 4 weeks prior and during study treatment.
  • Patient with treatment with systemic immunosuppressive medication (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with exceptions.
  • Patient who received administration of a live, attenuated vaccine within 4 weeks prior to study enrollment infusion or anticipation that such a live, attenuated vaccine will be required during the study or within 5 months after the last dose of study treatment.
  • Other Exclusions:
  • Patient with history of illicit drug or alcohol abuse within 12 months prior to screening, in the Investigator's judgment.
  • Patient with history of severe allergic anaphylactic reactions to chimeric or humanized monoclonal antibodies or recombinant antibody-related fusion proteins.
  • Patient with known hypersensitivity to Chinese hamster ovary (CHO) cell products or to any component of the rituximab, obinutuzumab, polatuzumab vedotin and/or glofitamab formulation and/or to the contrast agents used in the study.
  • Female patient is pregnant or breast feeding. Female patients of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study treatment.
  • Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.
  • Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts.
  • Patients who are dependent on the sponsor, the investigator or the trial site.

Trial locations and contacts

28 sites in 2 countries.

28 sites in 2 countries

Germany20 sites

  • Charité - Universitätsmedizin Berlin

    Berlin

  • HELIOS Klinikum Berlin-Buch

    Berlin

  • Medizinisches Universitätsklinikum Knappschaftskrankenhaus Bochum

    Bochum

  • Klinikum Chemnitz

    Chemnitz

  • Uniklinikum Düsseldorf

    Düsseldorf

  • Universitätsklinikum Erlangen

    Erlangen

  • Ev. Klinikum Essen-Mitte

    Essen

  • Westdeutsches Tumorzentrum Essen

    Essen

  • Universitätsklinikum Halle

    Halle

  • University Hospital Jena

    Jena

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    Kiel

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Klinikum Ludwigshafen

    Ludwigshafen, 67063

  • Universitätsklinikum Magdeburg

    Magdeburg, Saxony-Anhalt, 39120

  • TU München (rechts des Isar)

    München

  • Unversitätsklinikum Münster

    Münster, 48149

  • Ortenauklinikum Offenburg-Kehl

    Offenburg

  • Universitätsklinikum Regensburg

    Regensburg

  • Kreiskliniken Reutlingen

    Reutlingen

  • Universitätsklinikum Würzburg

    Würzburg

Other trials in Germany

Austria8 sites

  • Uniklinik Innsbruck

    Innsbruck

  • Kepler Universitätsklinikum

    Linz

  • Ordensklinikum Linz - Barmherzige Schwestern

    Linz

  • Ordensklinikum Linz - Elisabethinen

    Linz

  • Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität

    Salzburg

  • Univ. Klinikum St. Pölten

    Sankt Pölten

  • AKH Meduni Wien

    Vienna

  • Hanusch Krankenhaus

    Vienna

Other trials in Austria

About this study

Official title: A Prospective Multicenter Phase 2 Study of the Chemotherapy-light Combination of Intravenous Rituximab With the Antibody-drug Conjugate Polatuzumab Vedotin and the Bispecific Antibody Glofitamab in Previously Untreated Aggressive B-cell Lymphoma Patients Above 60 Years of Age Ineligible for a Fully Dosed R-CHOP

In the present trial the chemotherapy- light treatment concept R-Pola-Glo will be evaluated that combines the anti-CD20 antibody rituximab (R) with the ADC polatuzumab vedotin (Pola) and the (BiMabs) glofitamab (Glo) in elderly and/or medical unfit and previously untreated patients with aggressive B-cell lymphoma. The outcome and feasibility data obtained here will be used for further clinical development of this new chemolight triple combination.

Being tested
Glofitamab, Rituximab, Obinutuzumab, Polatuzumab vedotin
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlofitamabDrug

    Glofitamab is a fully humanized, engineered monoclonal bivalent antibody of the IgG1 isotype.

  • RituximabDrug

    Rituximab is a genetically engineered chimeric mouse/human anti-CD20 monoclonal antibody

  • ObinutuzumabDrug

    Obinutuzumab is a fully humanized, glycoengineered type II monoclonal antibody of the IgG1 isotype that binds to an epitope on CD20

  • Polatuzumab vedotinDrug

    Polatuzumab vedotin is an antibody-drug-conjugate that contains a humanized IgG1 anti-CD79b monoclonal antibody (MCDS4409A) and a potent anti-mitotic agent (MMAE) linked through a protease-cleavable linker.

Study groups in NCT05798156
Study groupRoleWhat they receive
chemolight R-Pola-Glo treatmentExperimentalNot described
Receives: Drug: Glofitamab; Drug: Rituximab; Drug: Obinutuzumab; Drug: Polatuzumab vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1 year progression-free survival (PFS) rate of the first 80 patients

    defined as the time from the day of inclusion until disease progression (PD) or relapse after complete remission (CR), or death due to any cause, whichever occurs first

    Measured: 12 months

Secondary outcomes (12)

  1. Event-free survival (EFS)

    defined as the time from the day of inclusion until progressive disease or relapse after complete remission, initiation of subsequent systemic antilymphoma treatment, radiation of single PET-CT positive lesions or death due to any cause, whichever occurs first.

    Measured: 54 months

  2. Overall survival (OS)

    defined as the time from the day of inclusion until death due to any cause

    Measured: 54 months

  3. Response rate at different timepoints

    Response rates after 2 cycles (during target dose phase), 6 cycles (end of target dose phase before start of consolidation phase) and 12 cycles (end of treatment following completion of consolidation phase). i.e., complete remission (CR) rate, partial remission (PR) rate, overall remission rate (ORR: CR+PR), stable disease (SD) rate and progressive disease (PD) rate

    Measured: 6 weeks, 18 weeks, 36 weeks

  4. Relapse rate

    defined as the number of patients with relapse, divided by the number of patients achieving C

    Measured: 54 months

  5. Conversion rate of PR to CR

    defined as the number of patients achieving mCR at the end of study treatment (including consolidation phase) divided by the number of patients achieving PR after end of target dose phase (before start of consolidation phase)

    Measured: 54 months

  6. Duration of response (DoR)

    defined as the time from documentation of CR until relapse or lymphoma associated death without documented relapse

    Measured: 54 months

  7. Rate and type of adverse events (AEs) and serious adverse events (SAEs)

    Measured: 54 months

  8. Rate of secondary malignancies

    defined as the number of patients with secondary malignancies divided by the number of analyzable patients

    Measured: 54 months

  9. Treatment-related death rate

    defined as the number of treatment related deaths during therapy or up to 2 months after the end of study treatment, but before the start of further treatment, divided by the number of analyzable patients

    Measured: 54 months

  10. Protocol adherence

    number and duration of R-Pola-Glo cycles, number and duration of glofitamab maintenance, cumulative and relative doses of rituximab, glofitamab and polatuzumab.

    Measured: 54 months

  11. Patient-reported outcomes for quality of life (QoL): EORTC QLQ-C30

    measured by EORTC QLQ-C30 (a 30-item questionnaire developed by the European Organisation for Research and Treatment of Cancer). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Measured: 54 months

  12. Patient-reported outcomes for quality of life (QoL): FACT-Lym

    measured by FACT-Lym (Functional Assessment of Cancer Therapy - Lymphoma; scores from 0 - 4; The higher the score, the better the QOL)

    Measured: 54 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start20 Mar 2023
  3. Primary completion12 Apr 2025
  4. Study completion28 Feb 2028 (estimated)

Resources

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
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05798156
Sponsor's protocol ID
R-Pola-Glo
Other IDs
ML44400, 2022-003398-51, GLA 2022-10, NHL-16, IKF-t062
Acronym
R-Pola-Glo
Status last verified
Apr 2026
First submitted
8 Mar 2023
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Glofitamab, Rituximab and Obinutuzumab in people with Lymphoma, Large B-Cell, Diffuse, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 28 sites in 2 countries.

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 20 inclusion and 32 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: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Germany, 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1 year progression-free survival (PFS) rate of the first 80 patients (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05798156.

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 8 Apr 2026.

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