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Immunotherapy after chemo may keep aggressive lymphoma at bay

NCT ID NCT03463057

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study tests whether the immunotherapy drug atezolizumab can help prevent relapse in people with high-risk diffuse large B-cell lymphoma (DLBCL) who have already achieved remission with standard chemotherapy (R-CHOP). About 109 adults aged 18–75 are receiving 18 cycles of atezolizumab followed by 12 months of observation. The main goal is to see if this approach improves disease-free survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Atezolizumab (Tecentriq)
What this could lead to
If it works, this could offer a way to keep high-risk DLBCL in remission longer after initial chemotherapy.
What could go wrong
This is a mid-stage trial with only 109 participants, so results may not apply to everyone. Atezolizumab can cause immune-related side effects, and it's unclear if it will improve survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

109 people

The number who actually took part.

Started

Aug 2018

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • BE-Antwerpen Edegem-UZA

    Antwerp, Belgium

  • BE-Antwerpen-ZNASTUIVENBERG

    Antwerp, Belgium

  • BE-Brugge-AZBRUGGE

    Bruges, Belgium

  • BE-Leuven-UZLEUVEN

    Leuven, Belgium

  • BE-Roeselare-AZDELTA

    Roeselare, Belgium

  • NL-Amersfoort-MEANDERMC

    Amersfoort, Netherlands

  • NL-Amsterdam-OLVG

    Amsterdam, Netherlands

  • NL-Amsterdam-VUMC

    Amsterdam, Netherlands

  • NL-Apeldoorn-GELREAPELDOORN

    Apeldoorn, Netherlands

  • NL-Breda-AMPHIA

    Breda, Netherlands

  • NL-Delft-RDGG

    Delft, Netherlands

  • NL-Den Bosch-JBZ

    's-Hertogenbosch, Netherlands

  • NL-Den Haag-HAGA

    The Hague, Netherlands

  • NL-Dordrecht-ASZ

    Dordrecht, Netherlands

  • NL-Ede-ZGV

    Ede, Netherlands

  • NL-Eindhoven-CATHARINA

    Eindhoven, Netherlands

  • NL-Eindhoven-MAXIMAMC

    Eindhoven, Netherlands

  • NL-Enschede-MST

    Enschede, Netherlands

  • NL-Groningen-UMCG

    Groningen, Netherlands

  • NL-Hilversum-TERGOOI

    Hilversum, Netherlands

  • NL-Hoofddorp-SPAARNEGASTHUIS

    Hoofddorp, Netherlands

  • NL-Leeuwarden-MCL

    Leeuwarden, Netherlands

  • NL-Leiden-LUMC

    Leiden, Netherlands

  • NL-Maastricht-MUMC

    Maastricht, Netherlands

  • NL-Nieuwegein-ANTONIUS

    Nieuwegein, Netherlands

  • NL-Nijmegen-CWZ

    Nijmegen, Netherlands

  • NL-Rotterdam-ERASMUSMC

    Rotterdam, Netherlands

  • NL-Rotterdam-MAASSTADZIEKENHUIS

    Rotterdam, Netherlands

  • NL-Sittard-Geleen-ZUYDERLAND

    Sittard, Netherlands

  • NL-Tilburg-ETZ

    Tilburg, Netherlands

  • NL-Utrecht-UMCUTRECHT

    Utrecht, Netherlands

  • NL-Zwolle-ISALA

    Zwolle, Netherlands

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