The Feasibility and Clinical Efficacy of Atezolizumab Consolidation Treatment in High Risk (IPI > 2) DLBCL (HO151DLBCL)

January 2, 2026 updated by: Stichting Hemato-Oncologie voor Volwassenen Nederland

A Phase II Study Evaluating the Feasibility and Clinical Efficacy of Atezolizumab Consolidation Treatment in High Risk Diffuse Large B-cell Lymphoma

The prognosis of Diffuse Large B cell Lymphoma (DLBCL) patients with an early relapse is dismal. Atezolizumab has shown promising activity in relapsed DLBCL patients. Toxicity data on atezolizumab are available for > 6000 patients and is manageable. The assumption of this study is that atezolizumab consolidation will result in higher disease free survival by eradicating minimal residual disease In melanoma and lung cancer consolidation immunotherapy after chemoradiotherapy has shown an increase in survival.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In high risk diffuse large B-cell lymphoma (DLBCL), International Prognostic Index (IPI)-score ≥ 3 21% of patients will relapse within 2-years after completion of R-CHOP induction treatment despite achieving a complete remission. Patient relapsing within a year after R-CHOP treatment have a very poor prognosis, even after second line chemotherapy, with only 15% of patients achieving a long remission. Therefore, additional therapy in first line treatment is required for these patients. The immune checkpoint inhibitor atezolizumab is a monoclonal antibody directed against the program death ligand 1 (PDL1). The PD1 and PDL1 inhibitors have shown excellent results in relapsed Hodgkin lymphoma and promising results in relapsed B-cell non Hodgkin lymphoma. Given the acceptable toxicity profile of atezolizumab, this study examines the efficacy and toxicity of atezolizumab as consolidation treatment after R-CHOP induction in DLBCL patients at high risk of relapse.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
109

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium
        • BE-Antwerpen Edegem-UZA
      • Antwerp, Belgium
        • BE-Antwerpen-ZNASTUIVENBERG
      • Bruges, Belgium
        • BE-Brugge-AZBRUGGE
      • Leuven, Belgium
        • BE-Leuven-UZLEUVEN
      • Roeselare, Belgium
        • BE-Roeselare-AZDELTA
  • Netherlands
      • 's-Hertogenbosch, Netherlands
        • NL-Den Bosch-JBZ
      • Amersfoort, Netherlands
        • NL-Amersfoort-MEANDERMC
      • Amsterdam, Netherlands
        • NL-Amsterdam-OLVG
      • Amsterdam, Netherlands
        • NL-Amsterdam-VUMC
      • Apeldoorn, Netherlands
        • NL-Apeldoorn-GELREAPELDOORN
      • Breda, Netherlands
        • NL-Breda-AMPHIA
      • Delft, Netherlands
        • NL-Delft-RDGG
      • Dordrecht, Netherlands
        • NL-Dordrecht-ASZ
      • Ede, Netherlands
        • NL-Ede-ZGV
      • Eindhoven, Netherlands
        • NL-Eindhoven-CATHARINA
      • Eindhoven, Netherlands
        • NL-Eindhoven-MAXIMAMC
      • Enschede, Netherlands
        • NL-Enschede-MST
      • Groningen, Netherlands
        • NL-Groningen-UMCG
      • Hilversum, Netherlands
        • NL-Hilversum-TERGOOI
      • Hoofddorp, Netherlands
        • NL-Hoofddorp-SPAARNEGASTHUIS
      • Leeuwarden, Netherlands
        • NL-Leeuwarden-MCL
      • Leiden, Netherlands
        • NL-Leiden-LUMC
      • Maastricht, Netherlands
        • NL-Maastricht-MUMC
      • Nieuwegein, Netherlands
        • NL-Nieuwegein-ANTONIUS
      • Nijmegen, Netherlands
        • NL-Nijmegen-CWZ
      • Rotterdam, Netherlands
        • NL-Rotterdam-ERASMUSMC
      • Rotterdam, Netherlands
        • NL-Rotterdam-MAASSTADZIEKENHUIS
      • Sittard, Netherlands
        • NL-Sittard-Geleen-ZUYDERLAND
      • The Hague, Netherlands
        • NL-Den Haag-HAGA
      • Tilburg, Netherlands
        • NL-Tilburg-ETZ
      • Utrecht, Netherlands
        • NL-Utrecht-UMCUTRECHT
      • Zwolle, Netherlands
        • NL-Zwolle-ISALA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-75 (inclusive) years
  • Patients with a confirmed histologic diagnosis of diffuse large B-cell lymphoma (DLBCL-NOS) based upon a representative histology specimen according to the World Health Association (WHO) classification, revision 2016
  • Ann Arbor stages II-IV
  • WHO performance status 0 - 1
  • International Prognostic Index (IPI) ≥ 3 at diagnosis
  • Complete metabolic remission (Deauville 1-3) after 6-8 cycles of R-CHOP according to the Lugano criteria

Of note:

  1. Rituximab may have been administered either intravenously or subcutaneously. A rituximab biosimilar may have been used when it is approved for the indication of DLBCL.
  2. Patients should have received at least 6 cycles R-CHOP. Dose reductions for vincristine are allowed during R-CHOP. Dose reductions because of bone marrow toxicity are allowed but cannot exceed >15% of cumulative dose of doxorubicin and cyclophosphamide.
  3. Central nervous system prophylaxis (MTX) by intrathecal therapy or IV is allowed.
  4. Fludeoxyglucose Positron Emission Tomography (18F-FDG-PET) scan should have been made 4-8 weeks after last induction cycle

  5. Histologically confirmed false positive EoT PET-scans are eligible.

    • Negative pregnancy test at study entry
    • Patient is willing and able use adequate contraception during and until 5 months after the last protocol treatment.
    • Patient is capable of giving a written informed consent

    Exclusion Criteria:

    Diagnosis

    • All histopathological diagnoses other than DLBCL-NOS according to the WHO classification, revision 2016, including:

    - High-grade B-cell lymphoma with a double/triple translocation with MYC, BCL2 and/or BCL6. Please note that patients with an isolated MYC translocation or an isolated BCL2 translocation or an isolated BCL-6 translocation are eligible (single hit translocation).

    • Testicular large B-cell lymphoma
    • Primary mediastinal B cell lymphoma
    • Transformed indolent lymphoma
    • Post-transplant lymphoproliferative disorder

    Organ dysfunction

    • Clinical signs of severe pulmonary dysfunction
    • Clinical signs of heart failure (New York Heart Association (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

    • Signs or known history of bleeding disorder.
    • 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 of the start of Cycle 1. Suspected active or latent tuberculosis needs to be confirmed by positive interferon gamma (IFN-γ) release assay

    • Patients known to be Human Immuno-deficiency 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 computer tomography (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 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, stage 0 cervical carcinoma or carcinoma in situ (for which no systemic treatment was indicated)

    • 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-programmed cell death protein-1 (anti PD-1) or PDL-1 antibodies.
    • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA4 therapeutic antibodies.
    • Treatment with systemic immunostimulatory agents (including but not limited to IFN, interleukin [IL]-2) within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1.
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Atezolizumab
18 cycles atezolizumab followed by 12 months of observation
Drug: Atezolizumab
Intervention Atezolizumab starts after 6 - 8 R-CHOP induction cycles (Rituximab, Cyclophosphamide, Hydroxo-doxorubicin, Vincristine and Prednisone (R-CHOP)); 18 cycles Atezolizumab followed by 12 months of observation
Other Names:
  • Tecentriq
  • L01XC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease free survival (DFS) measured from the date of registration to relapse or death from any cause whichever comes first.
Time Frame: 2 year after inclusion last patient
To evaluate the 2-year DFS for patients in complete metabolic remission after R-CHOP induction
2 year after inclusion last patient

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
(Severe) Adverse Events and the relation of adverse events in time to the recovery of the T-cell repertoire.
Time Frame: 2 years after inclusion last patient
To evaluate toxicity and assess the relation of adverse events in time to recovery of the T-cell repertoire.
2 years after inclusion last patient
Overall survival (OS), calculated from registration until death from any cause. Patients still alive or lost to follow up are censored at the last date known to be alive.
Time Frame: 2 years after inclusion last patient
To evaluate the 2-year OS.
2 years after inclusion last patient
The relationship between MRD status at the end-of-induction and end-of-consolidation therapy.
Time Frame: 2 years after inclusion last patient
To evaluate MRD status at the end of induction therapy, at various time points during consolidation treatment and at the end of consolidation.
2 years after inclusion last patient
The relation between MRD conversion and 2-years DFS and OS.
Time Frame: 2 years after inclusion last patient
To evaluate if there is a relation between MRD conversion and 2-years DFS and OS.
2 years after inclusion last patient
The relation between the T-cell and NK cell repertoire and adverse events.
Time Frame: 2 years after inclusion last patient
To evaluate the recovery of the T-cell and NK cell repertoire after induction therapy and at various time points during consolidation treatment in relation to toxicity and efficacy.
2 years after inclusion last patient

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Atezolizumab spinal fluid concentration as assessed by spinal fluid measurements will be performed in patients receiving atezolizumab.
Time Frame: 2 years after inclusion last patient
To assess the crossing of the blood-brain barrier of atezolizumab by measuring atezolizumab concentrations in het cerebrospinal fluid.
2 years after inclusion last patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stichting Hemato-Oncologie voor Volwassenen Nederland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: M. Nijland, PhD/MD, NL-Groningen-UMCG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 18, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HO151
  • 2017-002605-35 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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