Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedNCT03850028
Molecular Imaging Using Radiolabeled Atezolizumab to Assess Atezolizumab Biodistribution in Lymphoma Patients
A study testing 89Zr-atezolizumab PET scans in people with Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial summary
Molecular imaging can be used for the noninvasive assessment of biodistribution of monoclonal antibodies. Atezolizumab has previously successfully been labeled with the radionucleotide Zirconium-89 (89Zr) and studied in solid malignancies (NCT02453984). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- What is being tested?
- 89Zr-atezolizumab PET scans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesNetherlands
- Study dates
- 22 May 2019to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 (inclusive) years
- Patients with a confirmed histologic diagnosis of diffuse large B-cell lymphoma not otherwise specified (DLBCL-NOS) based upon a representative histology specimen according to the World Health Organization (WHO) classification, revision 2016 (see appendix A)
- Ann Arbor stages II-IV (see appendix B)
- WHO performance status 0 - 1 (see appendix E)
- international prognostic index (IPI) ≥ 3 at diagnosis (see appendix C)
- Negative pregnancy test at study entry
Show all 9Show fewer
- Patient is willing and able use adequate contraception during and until 5 months after the last protocol treatment.
- Written informed consent
- Patient is capable of giving a written informed consent
Who cannot join
- Diagnosis
- All histopathological diagnoses other than DLBCL-NOS according to the WHO classification, revision 2016 (see appendix A), including:
- High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 translocations
- Testicular large B-cell lymphoma
- Primary mediastinal B cell lymphoma
- Transformed indolent lymphoma
Show all 42Show fewer
- Post-transplant lymphoproliferative disorder
- Organ dysfunction
- Clinical signs of severe pulmonary dysfunction
- Clinical signs of heart failure (NYHA classification II-IV)
- Symptomatic coronary artery disease or cardiac arrhythmias not well controlled with medication.
- Myocardial infarction during the last 6 months
- Significant renal dysfunction (serum creatinine ≥ 150 umol/l or clearance ≤ 30ml/min
- Creatinine clearance (CrCl) may be calculated by Cockcroft -Gault formula:
- CrCl = (140 - age [in years]) x weight [kg] (x 0.85 for females) / (0.815 x serum creatinine [μmol/L])
- Inadequate hematological function: hemoglobin < 5.5 mmol/L,absolute neutrophil count (ANC) < 1.0x10^9/L or platelets < 75x10^9 /L
- Spontaneous international normalized ratio (INR) > 1.5, activated partial thromboplastin time (aPTT) >33
- Significant hepatic dysfunction (total bilirubin ≥ 1.5x upper limit of normal (ULN) or transaminases ≥ 2.5 x ULN), unless related to Gilberts syndrome.
- Clinical signs of severe cerebral dysfunction
- Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
- Major surgery within the last 4 weeks
- Known or suspected infection
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks before date of registration. Suspected active or latent tuberculosis needs to be confirmed by positive interferon gamma (IFN-γ) release assay
- Patients known to be human immunodeficiency virus (HIV)-positive
- Active chronic hepatitis B or C infection
- Administration of a live, attenuated vaccine within 4 weeks before date of registration or anticipation that such a live attenuated vaccine will be required during the study and for a period of 5 months after discontinuation of atezolizumab
- Auto-immune
- Any active or history of documented autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. The following exceptions are allowed: Patients with autoimmune-related hypothyroidism or type 1 diabetes mellitus who are on stable treatment.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest CT scan at screening.
- Patients with uncontrolled asthma or allergy, requiring systemic steroid treatment
- Regular treatment with corticosteroids within the 4 weeks prior to date of registration, unless administered for indications other than non-Hodgkin lymphoma (NHL) at a dose equivalent to < 30 mg/day prednisone/prednisolone.
- General
- Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease)
- Current participation in another clinical trial interfering with this trial
- History of active cancer during the past 5 years, except basal cell carcinoma of the skin or stage 0 cervical carcinoma
- Life expectancy < 6 months
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Prior treatment
- Prior treatment with atezolizumab, or anti PD1 or PDL1 antibodies.
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) therapeutic antibodies.
- Treatment with systemic immunostimulatory agents (including but not limited to interferon (IFN), interleukin (IL)-2) within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to date of registration.
- Treatment with systemic immunosuppressive medications, including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti- tumor necrosis factor (anti-TNF) agents within 2 weeks prior to date of registration; inhaled corticosteroids and mineralocorticoids are allowed.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
VU University Medical Center
Amsterdam, North Holland, 1081HV
University Medical Center Groningen
Groningen, 9100 RB
About this study
Official title: Molecular Imaging of Zirconium-89-labeled Atezolizumab as a Tool to Investigate Atezolizumab Biodistribution in High-risk Diffuse Large B-cell Lymphoma
Molecular imaging can be used for the noninvasive assessment of biodistribution of monoclonal antibodies. Atezolizumab has previously successfully been labeled with the radionucleotide Zirconium-89 (89Zr) and studied in solid malignancies (NCT02453984). The results of atezolizumab biodistribution can help to get a better understanding of the response mechanisms, the relation with minimal residual disease, the relation with the status of the T-cell and natural killer (NK)-cell repertoire and toxicity of programmed death ligand 1 (PDL1) checkpoint inhibition. Possibly in the future this will facilitate optimal patient selection. Sequential 89Zr-atezolizumab positron emission tomography (PET) scans can provide information on the dynamics of atezolizumab biodistribution over time. In combination with repeated characterization of tumor tissue and blood samples, these results can give inside in primary and acquired resistance.
In this parallel study of the HOVON 151 trial, 89Zr-atezolizumab-PET-scans will be used to evaluate 20 high risk DLBCL patients before and after induction (R-CHOP) therapy, and at suspected relapse during or after atezolizumab consolidation (HOVON 151).
Read the detailed description
Patients with a high risk diffuse large B-cell lymphoma (DLBLC) with an international prognostic score (IPI) > 2, have a high risk of relapse even after achieving a metabolic complete remission with cyclophosphamide, doxorubicin, vincristine, prednisone and rituximab (R-CHOP) chemo-immunotherapy. Outcome after relapse is dismal. In patients with varies types of relapsed lymphoma checkpoint inhibition have shown promising results.
In order to improve outcome patients with a high risk DLBCL will be treated in the HOVON 151 trial (EudracT 2017-002605-35) with the monoclonal antibody directed against the immune checkpoint program death ligand 1 (PDL1) atezolizumab for 1 year after achieving a complete metabolic remission with R-CHOP.
The observed percentage of PDL1 positive tumor cells in DLBCL cases ranges from 13 to 31%. For PD-1/PDL1 checkpoint inhibition PDL1 tumor surface expression was proposed as a potential predictive marker. Despite higher overall response rates in PDL1 positive malignancies compared to PDL1 negative tumors, responses are seen in PDL1 negative patients nevertheless. PDL1 status from resected specimens showed a poor correlation to the PDL1 status from matched biopsies. Furthermore it has been shown that PDL1 expression in tumor biopsies changes with treatment. Therefore, PDL1 expression assessed by one single biopsy might not be representative.
Molecular imaging can be used for the noninvasive assessment of biodistribution of monoclonal antibodies. Atezolizumab has previously successfully been labeled with the radionucleotide Zirconium-89 (89Zr) and studied in solid malignancies (NCT02453984). The results of atezolizumab biodistribution can help to get a better understanding of the response mechanisms, the relation with minimal residual disease, the relation with the status of the T-cell and natural killer (NK)-cell repertoire and toxicity of programmed death ligand 1 (PDL1) checkpoint inhibition. Possibly in the future this will facilitate optimal patient selections. Sequential 89Zr-atezolizumab PET scans can provide information on the dynamics of atezolizumab biodistribution over time. In combination with repeated characterization of tumor tissue and blood samples, these results can give inside in the primary and acquired resistance.
In this parallel study of the HOVON 151 trial, 89Zr-atezolizumab-PET-scans will be used to evaluate 20 high risk DLBCL patients before and after induction (R-CHOP) therapy, and at suspected relapse during or after atezolizumab consolidation (HOVON 151).
- Being tested
- 89Zr-atezolizumab PET scans
- Keywords
- high risk DLBCL, molecular imaging, 89Zr-atezolizumab-PET, PDL1 imaging
- 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.
89Zr-atezolizumab PET scansOther
The anti-PDL1 antibody atezolizumab, labeled with Zirconium-89 (89Zr) will be used as a molecular imaging tracer for PET scanning.
These 89Zr-atezolizumab PET scans will be performed before and after induction therapy (R-CHOP) and at suspected relapse during or after consolidation treatment with atezolizumab (treatment trial HOVON 151).
| Study group | Role | What they receive |
|---|---|---|
| Imaging cohort | Other | All study participants will be allocated to this arm (single-arm study). Study participants will undergo a maximum of 3 89Zr-atezolizumab PET scans. Receives: Other: 89Zr-atezolizumab PET scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodistribution of 89Zr-atezolizumab
The biodistribution of the tracer 89Zr-atezolizumab as assessed with 89Zr-atezolizumab PET scans.
Measured: From 2 weeks before R-CHOP until 52 weeks after R-CHOP
Secondary outcomes (4)
PDL1 and human leukocyte antigen (HLA) expression using immunohistochemistry (IHC)
Tumor and immune cell PDL1 and HLA expression on archival pre-treatment biopsy via IHC.
Measured: IHC for PDL1 and HLA expression on archival tumor tissue will be performed after initial biopsy at time of diagnosis.
Soluble programmed death ligand 1 (sPDL1) measurement using an enzyme-linked immunosorbent assay (ELISA).
sPDL1 serum levels will be determined with ELISA
Measured: From 2 weeks before R-CHOP until 52 weeks after R-CHOP
Gene expression profiling (GEP) via Nanostring
GEP via Nanostring analysis for cell-of origin will be perfomed on archival, paraffin fixed biopsies.
Measured: From 2 weeks before R-CHOP until 52 weeks after R-CHOP
Next generation sequencing (NGS) data
Mutational analysis will be perfomed on archival, paraffin fixed biopsies.
Measured: From 2 weeks before R-CHOP until 52 weeks after R-CHOP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start22 May 2019
- Primary completion1 May 2022
- Study completion1 May 2022
Why it stopped: Closed prematurely because the accrual was not achieved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Stichting Hemato-Oncologie voor Volwassenen Nederland, Hoffmann-La Roche
- Responsible party
- Principal investigator, Marcel Nijland, University Medical Center Groningen
- Investigators
- Marcel Nijland, MD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850028
- Sponsor's protocol ID
- 201700599
- Other IDs
- 2017-003511-20, NL63047.042.18, 2017
- Status last verified
- May 2023
- First submitted
- 15 Feb 2019
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging of Zirconium-89-labeled Atezolizumab as a Tool to Investigate Atezolizumab Biodistribution in High-risk Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT03850028
- Acronym / sponsor ID
- 201700599
- Keywords
- high risk DLBCL, molecular imaging, 89Zr-atezolizumab-PET, PDL1 imaging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Closed prematurely because the accrual was not achieved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Stichting Hemato-Oncologie voor Volwassenen Nederland, Hoffmann-La Roche
- Study start
- 22 May 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 21 Feb 2019 (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.
Molecular imaging can be used for the noninvasive assessment of biodistribution of monoclonal antibodies. Atezolizumab has previously successfully been labeled with the radionucleotide Zirconium-89 (89Zr) and studied in solid malignancies (NCT02453984). The results of atezolizumab biodistribution can help to get a better understanding of the response mechanisms, the relation with minimal residual disease, the relation with the status of the T-cell and natural killer (NK)-cell repertoire and toxicity of programmed death ligand 1 (PDL1) checkpoint inhibition. Possibly in the future this will facilitate optimal patient selection. Sequential 89Zr-atezolizumab positron emission tomography (PET) scans can provide information on the dynamics of atezolizumab biodistribution over time. In combination with repeated characterization of tumor tissue and blood samples, these results can give inside in primary and acquired resistance.
In this parallel study of the HOVON 151 trial, 89Zr-atezolizumab-PET-scans will be used to evaluate 20 high risk DLBCL patients before and after induction (R-CHOP) therapy, and at suspected relapse during or after atezolizumab consolidation (HOVON 151).
Detailed description
Patients with a high risk diffuse large B-cell lymphoma (DLBLC) with an international prognostic score (IPI) > 2, have a high risk of relapse even after achieving a metabolic complete remission with cyclophosphamide, doxorubicin, vincristine, prednisone and rituximab (R-CHOP) chemo-immunotherapy. Outcome after relapse is dismal. In patients with varies types of relapsed lymphoma checkpoint inhibition have shown promising results.
In order to improve outcome patients with a high risk DLBCL will be treated in the HOVON 151 trial (EudracT 2017-002605-35) with the monoclonal antibody directed against the immune checkpoint program death ligand 1 (PDL1) atezolizumab for 1 year after achieving a complete metabolic remission with R-CHOP.
The observed percentage of PDL1 positive tumor cells in DLBCL cases ranges from 13 to 31%. For PD-1/PDL1 checkpoint inhibition PDL1 tumor surface expression was proposed as a potential predictive marker. Despite higher overall response rates in PDL1 positive malignancies compared to PDL1 negative tumors, responses are seen in PDL1 negative patients nevertheless. PDL1 status from resected specimens showed a poor correlation to the PDL1 status from matched biopsies. Furthermore it has been shown that PDL1 expression in tumor biopsies changes with treatment. Therefore, PDL1 expression assessed by one single biopsy might not be representative.
Molecular imaging can be used for the noninvasive assessment of biodistribution of monoclonal antibodies. Atezolizumab has previously successfully been labeled with the radionucleotide Zirconium-89 (89Zr) and studied in solid malignancies (NCT02453984). The results of atezolizumab biodistribution can help to get a better understanding of the response mechanisms, the relation with minimal residual disease, the relation with the status of the T-cell and natural killer (NK)-cell repertoire and toxicity of programmed death ligand 1 (PDL1) checkpoint inhibition. Possibly in the future this will facilitate optimal patient selections. Sequential 89Zr-atezolizumab PET scans can provide information on the dynamics of atezolizumab biodistribution over time. In combination with repeated characterization of tumor tissue and blood samples, these results can give inside in the primary and acquired resistance.
In this parallel study of the HOVON 151 trial, 89Zr-atezolizumab-PET-scans will be used to evaluate 20 high risk DLBCL patients before and after induction (R-CHOP) therapy, and at suspected relapse during or after atezolizumab consolidation (HOVON 151).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging cohort | Other | Other: 89Zr-atezolizumab PET scansAll study participants will be allocated to this arm (single-arm study). Study participants will undergo a maximum of 3 89Zr-atezolizumab PET scans. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-75 (inclusive) years
- Patients with a confirmed histologic diagnosis of diffuse large B-cell lymphoma not otherwise specified (DLBCL-NOS) based upon a representative histology specimen according to the World Health Organization (WHO) classification, revision 2016 (see appendix A)
- Ann Arbor stages II-IV (see appendix B)
- WHO performance status 0 - 1 (see appendix E)
- international prognostic index (IPI) ≥ 3 at diagnosis (see appendix C)
Key exclusion criteria (42 listed)
- Diagnosis
- All histopathological diagnoses other than DLBCL-NOS according to the WHO classification, revision 2016 (see appendix A), including:
- High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 translocations
- Testicular large B-cell lymphoma
- Primary mediastinal B cell lymphoma
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 |
|---|---|---|
| 89Zr-atezolizumab PET scansThe anti-PDL1 antibody atezolizumab, labeled with Zirconium-89 (89Zr) will be used as a molecular imaging tracer for PET scanning. These 89Zr-atezolizumab PET scans will be performed before and after induction therapy (R-CHOP) and at suspected relapse during or after consolidation treatment with atezolizumab (treatment trial HOVON 151). | Other | Imaging cohort |
Primary outcome
Biodistribution of 89Zr-atezolizumab
Time frame: From 2 weeks before R-CHOP until 52 weeks after R-CHOP
The biodistribution of the tracer 89Zr-atezolizumab as assessed with 89Zr-atezolizumab PET scans.
4 secondary outcomes
PDL1 and human leukocyte antigen (HLA) expression using immunohistochemistry (IHC)
Time frame: IHC for PDL1 and HLA expression on archival tumor tissue will be performed after initial biopsy at time of diagnosis.
Soluble programmed death ligand 1 (sPDL1) measurement using an enzyme-linked immunosorbent assay (ELISA).
Time frame: From 2 weeks before R-CHOP until 52 weeks after R-CHOP
Gene expression profiling (GEP) via Nanostring
Time frame: From 2 weeks before R-CHOP until 52 weeks after R-CHOP
Next generation sequencing (NGS) data
Time frame: From 2 weeks before R-CHOP until 52 weeks after R-CHOP
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Marcel Nijland, MD principal investigator
University Medical Center Groningen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 89Zr-atezolizumab PET scans in people with Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, run by University Medical Center Groningen at 2 sites in Netherlands.
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 42 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: withdrawn, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Biodistribution of 89Zr-atezolizumab (time frame: From 2 weeks before R-CHOP until 52 weeks after R-CHOP). 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 15 May 2023.