NCT03463057

Brief Summary

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for phase_2

Timeline
8mo left

Started Aug 2018

Longer than P75 for phase_2

Geographic Reach
2 countries

32 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Aug 2018Jan 2027

First Submitted

Initial submission to the registry

February 23, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

August 30, 2018

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

January 5, 2026

Status Verified

October 1, 2025

Enrollment Period

5.4 years

First QC Date

February 23, 2018

Last Update Submit

January 2, 2026

Conditions

DLBCLNHL

Outcome Measures

Primary Outcomes (1)

  • Disease free survival (DFS) measured from the date of registration to relapse or death from any cause whichever comes first.

    To evaluate the 2-year DFS for patients in complete metabolic remission after R-CHOP induction

    2 year after inclusion last patient

Secondary Outcomes (5)

  • (Severe) Adverse Events and the relation of adverse events in time to the 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.

    2 years after inclusion last patient

  • The relationship between MRD status at the end-of-induction and end-of-consolidation therapy.

    2 years after inclusion last patient

  • The 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.

    2 years after inclusion last patient

Other Outcomes (1)

  • Atezolizumab spinal fluid concentration as assessed by spinal fluid measurements will be performed in patients receiving atezolizumab.

    2 years after inclusion last patient

Study Arms (1)

Atezolizumab

OTHER

18 cycles atezolizumab followed by 12 months of observation

Drug: Atezolizumab

Interventions

AtezolizumabDRUG

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

Also known as: Tecentriq, L01XC
Atezolizumab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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.
  • 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.
  • Central nervous system prophylaxis (MTX) by intrathecal therapy or IV is allowed.
  • Fludeoxyglucose Positron Emission Tomography (18F-FDG-PET) scan should have been made 4-8 weeks after last induction cycle
  • 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

You may not qualify if:

  • 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 \[μmol/L\])
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

BE-Antwerpen Edegem-UZA

Antwerp, Belgium

Location

BE-Antwerpen-ZNASTUIVENBERG

Antwerp, Belgium

Location

BE-Brugge-AZBRUGGE

Bruges, Belgium

Location

BE-Leuven-UZLEUVEN

Leuven, Belgium

Location

BE-Roeselare-AZDELTA

Roeselare, Belgium

Location

NL-Den Bosch-JBZ

's-Hertogenbosch, Netherlands

Location

NL-Amersfoort-MEANDERMC

Amersfoort, Netherlands

Location

NL-Amsterdam-OLVG

Amsterdam, Netherlands

Location

NL-Amsterdam-VUMC

Amsterdam, Netherlands

Location

NL-Apeldoorn-GELREAPELDOORN

Apeldoorn, Netherlands

Location

NL-Breda-AMPHIA

Breda, Netherlands

Location

NL-Delft-RDGG

Delft, Netherlands

Location

NL-Dordrecht-ASZ

Dordrecht, Netherlands

Location

NL-Ede-ZGV

Ede, Netherlands

Location

NL-Eindhoven-CATHARINA

Eindhoven, Netherlands

Location

NL-Eindhoven-MAXIMAMC

Eindhoven, Netherlands

Location

NL-Enschede-MST

Enschede, Netherlands

Location

NL-Groningen-UMCG

Groningen, Netherlands

Location

NL-Hilversum-TERGOOI

Hilversum, Netherlands

Location

NL-Hoofddorp-SPAARNEGASTHUIS

Hoofddorp, Netherlands

Location

NL-Leeuwarden-MCL

Leeuwarden, Netherlands

Location

NL-Leiden-LUMC

Leiden, Netherlands

Location

NL-Maastricht-MUMC

Maastricht, Netherlands

Location

NL-Nieuwegein-ANTONIUS

Nieuwegein, Netherlands

Location

NL-Nijmegen-CWZ

Nijmegen, Netherlands

Location

NL-Rotterdam-ERASMUSMC

Rotterdam, Netherlands

Location

NL-Rotterdam-MAASSTADZIEKENHUIS

Rotterdam, Netherlands

Location

NL-Sittard-Geleen-ZUYDERLAND

Sittard, Netherlands

Location

NL-Den Haag-HAGA

The Hague, Netherlands

Location

NL-Tilburg-ETZ

Tilburg, Netherlands

Location

NL-Utrecht-UMCUTRECHT

Utrecht, Netherlands

Location

NL-Zwolle-ISALA

Zwolle, Netherlands

Location

Related Publications (1)

  • Nijland M, Issa DE, Bult JAA, Deeren D, Velders GA, Nijziel MR, Sandberg Y, Vergote V, Oosterveld M, Fijnheer R, Brouwer RE, Boersma RS, Wu K, Nieuwenhuizen L, Vermaat JSP, van Kampen RJW, Terpstra WE, Snauwaert S, van der Poel MW, de Jongh E, Durian MF, Strobbe L, Beeker A, Gadisseur A, van Rijn RS, Visser O, Doorduijn JK, Snijders TJF, Silbermann MH, de Jong D, Chamuleau M, Mous R, Jalving H, Visser-Wisselaar H, Jansen van de Bergh S, Zwezerijnen GJC, Bremer E, Brink M, Diepstra A, Chitu DA, Koene HR, Zijlstra JM. Atezolizumab consolidation in patients with high-risk diffuse large B-cell lymphoma in complete remission after R-CHOP. Blood Adv. 2025 Jul 22;9(14):3530-3539. doi: 10.1182/bloodadvances.2024015226.

    PMID: 40249860DERIVED

Related Links

MeSH Terms

Interventions

atezolizumab

Study Officials

  • M. Nijland, PhD/MD

    NL-Groningen-UMCG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 13, 2018

Study Start

August 30, 2018

Primary Completion

January 18, 2024

Study Completion (Estimated)

January 1, 2027

Last Updated

January 5, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(5)NL(27)