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

Primary Purpose

Lymphoma, Large B-Cell, Diffuse

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Glofitamab
Rituximab
Obinutuzumab
Polatuzumab vedotin
Sponsored by
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

61 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient has provided written informed consent and is able and willing to comply with the study protocol and protocol mandated hospitalizations 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. 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 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. Exclusion Criteria: 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). 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 § 40 Abs. 1 S. 3 Nr. 4 AMG. 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 [§ 40 Abs. 1 S. 3 Nr. 3a AMG]. Patients who are dependent on the sponsor, the investigator or the trial site.

Sites / Locations

  • Kepler Universitätsklinikum
  • Ordensklinikum Linz - Barmherzige SchwesternRecruiting
  • Ordensklinikum Linz - Elisabethinen
  • Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen PrivatuniversitätRecruiting
  • Univ. Klinikum St. PöltenRecruiting
  • AKH Meduni Wien
  • Hanusch Krankenhaus
  • Charité - Universitätsmedizin Berlin
  • HELIOS Klinikum Berlin-Buch
  • Klinikum Chemnitz
  • Universitätsklinikum Erlangen
  • University Hospital Jena
  • Universitätsklinikum Schleswig-Holstein Campus Kiel
  • Universitätsklinikum Leipzig
  • Klinikum Ludwigshafen
  • TU München (rechts des Isar)
  • Unversitätsklinikum Münster
  • Universitätsklinikum Würzburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chemolight R-Pola-Glo treatment

Arm Description

Outcomes

Primary Outcome Measures

1 year progression-free survival (PFS) rate
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

Secondary Outcome Measures

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.
Overall survival (OS)
defined as the time from the day of inclusion until death due to any cause
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
Relapse rate
defined as the number of patients with relapse, divided by the number of patients achieving C
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)
Duration of response (DoR)
defined as the time from documentation of CR until relapse or lymphoma associated death without documented relapse
Rate and type of adverse events (AEs) and serious adverse events (SAEs)
Rate of secondary malignancies
defined as the number of patients with secondary malignancies divided by the number of analyzable patients
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
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.
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.
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)

Full Information

First Posted
March 8, 2023
Last Updated
May 30, 2023
Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Collaborators
Charite University, Berlin, Germany, University of Salzburg, Arbeitsgemeinschaft medikamentoese Tumortherapie, Roche Pharma AG, Zentrum für Klinische Studien Leipzig, Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05798156
Brief Title
Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive Large B-cell Lymphoma Ineligible for R-CHOP
Acronym
R-Pola-Glo
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 Large Bcell Lymphoma Patients Above 60 Years of Age Ineligible for a Fully Dosed R-CHOP
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
September 30, 2027 (Anticipated)
Study Completion Date
September 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Collaborators
Charite University, Berlin, Germany, University of Salzburg, Arbeitsgemeinschaft medikamentoese Tumortherapie, Roche Pharma AG, Zentrum für Klinische Studien Leipzig, Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. The outcome and feasibility data obtained here will be used for further clinical development of this new chemolight triple combination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large B-Cell, Diffuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chemolight R-Pola-Glo treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Glofitamab
Intervention Description
Glofitamab is a fully humanized, engineered monoclonal bivalent antibody of the IgG1 isotype.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Rituximab is a genetically engineered chimeric mouse/human anti-CD20 monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Intervention Description
Obinutuzumab is a fully humanized, glycoengineered type II monoclonal antibody of the IgG1 isotype that binds to an epitope on CD20
Intervention Type
Drug
Intervention Name(s)
Polatuzumab vedotin
Intervention Description
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.
Primary Outcome Measure Information:
Title
1 year progression-free survival (PFS) rate
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Event-free survival (EFS)
Description
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.
Time Frame
54 months
Title
Overall survival (OS)
Description
defined as the time from the day of inclusion until death due to any cause
Time Frame
54 months
Title
Response rate at different timepoints
Description
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
Time Frame
6 weeks, 18 weeks, 36 weeks
Title
Relapse rate
Description
defined as the number of patients with relapse, divided by the number of patients achieving C
Time Frame
54 months
Title
Conversion rate of PR to CR
Description
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)
Time Frame
54 months
Title
Duration of response (DoR)
Description
defined as the time from documentation of CR until relapse or lymphoma associated death without documented relapse
Time Frame
54 months
Title
Rate and type of adverse events (AEs) and serious adverse events (SAEs)
Time Frame
54 months
Title
Rate of secondary malignancies
Description
defined as the number of patients with secondary malignancies divided by the number of analyzable patients
Time Frame
54 months
Title
Treatment-related death rate
Description
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
Time Frame
54 months
Title
Protocol adherence
Description
number and duration of R-Pola-Glo cycles, number and duration of glofitamab maintenance, cumulative and relative doses of rituximab, glofitamab and polatuzumab.
Time Frame
54 months
Title
Patient-reported outcomes for quality of life (QoL): EORTC QLQ-C30
Description
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.
Time Frame
54 months
Title
Patient-reported outcomes for quality of life (QoL): FACT-Lym
Description
measured by FACT-Lym (Functional Assessment of Cancer Therapy - Lymphoma; scores from 0 - 4; The higher the score, the better the QOL)
Time Frame
54 months
Other Pre-specified Outcome Measures:
Title
Rate of minimal residual disease (MRD)-negative patients after end of target phase and at end of treatment
Time Frame
54 months
Title
Duration of molecular remission for MRD negative patients
Time Frame
54 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient has provided written informed consent and is able and willing to comply with the study protocol and protocol mandated hospitalizations 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. 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 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. Exclusion Criteria: 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). 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 § 40 Abs. 1 S. 3 Nr. 4 AMG. 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 [§ 40 Abs. 1 S. 3 Nr. 3a AMG]. Patients who are dependent on the sponsor, the investigator or the trial site.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Björn Chapuy, Univ.-Prof. Dr. med.
Phone
+49 30 450 613423
Email
bjoern.chapuy@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Greil, Univ. Prof. Dr. med.
Email
r.greil@salk.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salah-Eddin Al-Batran, Prof. Dr.
Organizational Affiliation
Institut fuer Klinische Krebsforschung IKF GmbH
Official's Role
Study Chair
Facility Information:
Facility Name
Kepler Universitätsklinikum
City
Linz
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clemens Schmitt
Facility Name
Ordensklinikum Linz - Barmherzige Schwestern
City
Linz
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Orlinger
Facility Name
Ordensklinikum Linz - Elisabethinen
City
Linz
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia Rotter
Facility Name
Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität
City
Salzburg
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Greil, Prof. Dr. med.
Facility Name
Univ. Klinikum St. Pölten
City
St. Pölten
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petra Pichler
Facility Name
AKH Meduni Wien
City
Wien
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phillip Staber
Facility Name
Hanusch Krankenhaus
City
Wien
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Panny
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Björn Chapuy, Prof. Dr.
Facility Name
HELIOS Klinikum Berlin-Buch
City
Berlin
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pearl van Heteren, Dr.
Facility Name
Klinikum Chemnitz
City
Chemnitz
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathias Hänel, PD Dr. med. habil.
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabian Müller, PD. Dr. med
Facility Name
University Hospital Jena
City
Jena
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulf Schnetzke, PD Dr. med.
Facility Name
Universitätsklinikum Schleswig-Holstein Campus Kiel
City
Kiel
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christiane Pott, Prof. Dr. med.
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Heyn, Dr. med.
Facility Name
Klinikum Ludwigshafen
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Hoffmann, Dr.
Facility Name
TU München (rechts des Isar)
City
München
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Lena Illert, Prof. Dr med.
Facility Name
Unversitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Kerkhoff, MD
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johannes Düll, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared.

Learn more about this trial

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

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