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Relapsed/Refractory Primary Central Nervous System LymphomaPhase 3IGNITENCT07104032

IGNITE: Study of Tirabrutinib vs Rituximab and Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)

A Phase 3 study testing Tirabrutinib, Rituximab and Temozolomide in people with Relapsed/Refractory Primary Central Nervous System Lymphoma, run by Ono Pharmaceutical Co., Ltd. at 42 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this clinical trial is to evaluate efficacy and safety of tirabrutinib alone compared with rituximab and temozolomide (R-TMZ) combination therapy in participants with Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tirabrutinib, Rituximab and Temozolomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
42 sitesin 7 countries
Study dates
12 Jun 2026to Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathology report confirming the diagnosis of B-cell PCNSL
  • Relapsed or refractory B-cell PCNSL with at least 1 prior high-dose methotrexate (HD-MTX) based therapy for PCNSL:
  • Relapsed disease: Participants who achieved a response (CR, CRu, PR) to the last treatment and subsequently experienced disease progression
  • Refractory disease: Participants whose best response to the last treatment was stable disease or PD
  • One or more measurable brain lesions with a diameter in at least one dimension greater than or equal to (≥) 1 centimeter (cm) in gadolinium-enhanced magnetic resonance imaging (MRI)
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
  • Adequate bone marrow, renal, and hepatic function per central lab values
  • Participants must agree to comply with all defined contraceptive requirements

Who cannot join

  • Participants with isolated intraocular PCNSL or spinal PCNSL with no brain lesions
  • Participants with non-B-cell PCNSL
  • Participants with systemic presence of lymphoma
  • Refractory to temozolomide with or without rituximab-containing regimens in the last PCNSL treatment
  • Concomitant systemic corticosteroid exposure within 14 days before starting study drug per Investigator assessment with the exception of the following:
  • Equivalent of up to 10 milligram per day (mg/day) of prednisone for a disease other than PCNSL
Show all 11Show fewer
  • Equivalent of up to 50 mg/day of prednisone (equal to 8 mg/day dexamethasone) for participants with lesions of the brain and/or spinal cord
  • Active malignancy, other than PCNSL requiring systemic therapy
  • Poorly controlled comorbidity, or history of medical conditions contraindicated per Investigator assessment
  • Participants who are unable to swallow oral medication
  • Prior Bruton's tyrosine kinase inhibitor treatment

Trial locations and contacts

42 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Clinical Team contact

888-724-3274

clinicaltrials@deciphera.com

42 sites in 7 countries

United States26 sites, 26 recruiting

  • University of Maryland

    Baltimore, Maryland, 21201

    Ben Kremenets, 410-328-7931, ben.kremenets@umm.edu

    Seung Lee, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Rebecca Lyons, 617-643-6081, RTLYONS@mgh.harvard.edu

    Tracy Batchelor, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

    Zeyuan Li, 617-667-7000, zli6@bidmc.harvard.edu

    Ka-Wai Grace Ho, MD

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

    Amanda Dresser, 617-582-9314, amanda_dresser@dfci.harvard.edu

    Lakshmi Nayak, MD

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Erin Severance, 919-668-6230, erin.k.bell@duke.edu

    Katherine Peters, MD, PhD

    Recruiting

  • Providence Medical Foundation

    Fullerton, California, 92835

    Michelle de Pol, 714-446-7523, michelle.depol@providence.org

    Jose Carrillo, MD

    Recruiting

  • University of Florida Gainesville

    Gainesville, Florida, 32610

    Taryn King, 352-273-6945, king.taryn@ufl.edu

    Ashley Ghiaseddin, MD

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Gregory Daszkiewicz, 551-996-8120, gregory.daszkiewicz@hmhn.org

    Andrew Ip, MD

    Recruiting

  • Penn State Health Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Sara Craig, 717-531-0003 ext. 285799, scraig2@pennstatehealth.psu.edu

    Dawit Aregawi, MD

    Recruiting

  • Mayo Clinic Cancer Center

    Jacksonville, Florida, 32224

    Jordan Oberhaus, 904-953-5288, oberhaus.jordan@mayo.edu

    Han Tun, MD

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06520

    Amy Rodrigues, 203-260-9632, amy.rodrigues@yale.edu

    Sylvia Kurz, MD

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Rachel Kim, 347-449-0107, rachel.kim3@nyulangone.org

    J Ricardo McFaline Figueroa, MD

    Recruiting

  • Columbia University Irving Medical Center

    New York, New York, 10032

    Eva Grace White, 212-304-6329, ew2926@cumc.columbia.edu

    Aya Haggiagi, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Kerina Yang, 901-883-8400, yangk3@mskcc.org

    Christian Grommes, MD

    Recruiting

  • UC Irvine Health

    Orange, California, 92868

    Katia Talamantez, 714-509-2370, talamank@hs.uci.edu

    Daniela Bota, MD, PhD

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Michael McNicholas, 267-804-4081, michael.mcnicholas@pennmedicine.upenn.edu

    Sunita Nasta, MD

    Recruiting

  • Mayo Clinic Cancer Center

    Phoenix, Arizona, 85054

    Eric Cruz, 480-574-3222, cruz.eric@mayo.edu

    Mazie Tsang, MD

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Theo Estep, 878-261-6727, esteptj2@upmc.edu

    Jan Drappatz, MD

    Recruiting

  • Providence Neurological Specialties West

    Portland, Oregon, 97225

    Eva Van Beek Van Beek, 503-216-1157, eva.vanbeek@providence.org

    Prakash Ambady, MD

    Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Stephen Donnelly, 401-444-4822, SDonnelly1@brownhealth.org

    Thomas Ollila, MD

    Recruiting

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

    Kathleen Elert, 507-538-3227, elert.kathleen@mayo.edu

    Patrick Johnston, MD, PhD

    Recruiting

  • University of Rochester Medicine Wilmot Cancer Institute - Webster

    Rochester, New York, 14642

    Matt Poquadeck, 585-273-2590, Matt_Poquadeck@urmc.rochester.edu

    Nimish Mohile, MD

    Recruiting

  • HonorHealth Cancer Center

    Scottsdale, Arizona, 85251

    Claudia Crooks, 602-258-2863, ccrooks@honorhealth.com

    Amir Azadi, MD

    Recruiting

  • University of Washington

    Seattle, Washington, 98195

    Dan Finlay, 206-667-3295, dfinlay@fredhutch.org

    Vyshak Venur, MD

    Recruiting

  • Atlantic Health Overlook Medical Center

    Summit, New Jersey, 07901

    Morgan Finlay, 908-522-5985, Morgan.Finlay@atlantichealth.org

    Robert Aiken, MD

    Recruiting

  • John Hopkins University

    Washington D.C., District of Columbia, 20016

    Mani Sreenivas, 202-660-5879, asreeni5@jhmi.edu

    Solmaz Sahebjam, MD

    Recruiting

Other trials in United States

Italy4 sites, 4 recruiting

  • ASST Spedali Civili di Brescia

    Brescia, Italy, 25123

    Chiara Pagani, +39 030 399 6416, chiara.pagani@asst-spedalicivili.it

    Alessandra Tucci, MD

    Recruiting

  • Azienda Sanitaria Ospedaliera Santa Croce e Carle

    Cuneo, Italy, 12100

    Davide Bisogno, 00 390171641571, bisogno.d@ospedale.cuneo.it

    Claudia Castellino, MD

    Recruiting

  • IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST

    Meldola, Italy, 47014

    Martina Ragazzini, + 39 0543739100, martina.ragazzini@irst.emr.it

    Gerardo Musuraca, MD

    Recruiting

  • Arcispedale S. Maria Nuova

    Reggio Emilia, 42123

    Alberto Bavieri, +39 0522295549, alberto.bavieri@ausl.re.it

    Fiorella Ilariucci, MD

    Recruiting

Other trials in Italy

Spain4 sites, 4 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain, 08035

    Mira Mireia, +34 932746000, mmira@vhio.net

    Pau Abrisqueta Costa, MD

    Recruiting

  • Hospital Clínic de Barcelona

    Barcelona, Spain, 08036

    +34 932275477, mozas@clinic.cat

    Pablo Mozas, MD

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, Spain, 28034

    Sara Ruiz, 34 913368631.00, sararuizperez.cc@gmail.com

    Francisco Javier López Jiménez, MD

    Recruiting

  • Hospital Universitario 12 De Octubre

    Madrid, Spain, 28041

    Maria San Segundo, +34 91 779 2809, mariah12oct@gmail.com

    Antonia Rodríguez Izquierdo, MD

    Recruiting

Other trials in Spain

France3 sites, 3 recruiting

  • Hôpitaux de Marseille

    Marseille, France, 13005

    04 91 38 55 00 ext. +33, laurence.schenone@ap-hm.fr

    Laurence Schenone, MD

    Recruiting

  • Hospital Center University De Montpellier

    Montpellier, France, 34090

    +33 (0)467338364, c-herbaux@chu-montpellier.fr

    Charles Herbaux, MD

    Recruiting

  • Centre Hospitalier Régional Universitaire (CHRU) de Tours - Hôpital Bretonneau

    Tours, France, 37044

    Delphine Labbe, +33 0218370539, D.LABBE@chu-tours.fr

    Emmanuel Gyan, MD

    Recruiting

Other trials in France

Australia2 sites, 2 recruiting

  • St Vincent's Hospital Sydney

    Darlinghurst, Australia, 2010

    Joshua Neish, 47 8267680.00, joshua.neish@svha.org.au

    Orly Lavee, MD

    Recruiting

  • Epworth Healthcare

    Melbourne, Victoria, 3002

    Connie Barlas, (03) 9516 2374, connie.barlas@epworth.org.au

    Costas Yannakou, MD

    Recruiting

Other trials in Australia

Czechia2 sites, 2 recruiting

  • University Hospital Ostrava

    Ostrava, Czechia, 708 52

    Michal Kascak, +420 597372151, michal.kascak@fno.cz

    Juraj Ďuraš, MD

    Recruiting

  • University Hospital Královské Vinohrady

    Prague, Czechia, 10034

    +420 267163554, heidi.mocikova@fnkv.cz

    Heidi Mocikova, MD

    Recruiting

Other trials in Czechia

Brazil1 site, 1 recruiting

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652-900

    Aline Raposo Nishimoto, +011 2151-0240, Aline.nishimoto@einstein.br

    Guilherme Fleury Perini, MD

    Recruiting

Other trials in Brazil

About this study

Official title: A Phase 3, Multiregional, Open-label, Randomized Study of Tirabrutinib vs Rituximab and Temozolomide in Participants With Relapsed/Refractory Primary Central Nervous System Lymphoma (IGNITE)

The purpose of this clinical trial is to evaluate efficacy and safety of tirabrutinib alone compared with rituximab and temozolomide (R-TMZ) combination therapy in participants with Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL).

Being tested
Tirabrutinib, Rituximab, Temozolomide
Keywords
Bruton's tyrosine kinase (BTK), IGNITE, PCNSL, Primary Central Nervous System Lymphoma, Relapsed/Refractory Primary Central Nervous System Lymphoma
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirabrutinibDrug

    Also called ONO-4059

    Administered orally.

  • RituximabDrug

    Administered intravenously (IV).

  • TemozolomideDrug

    Administered orally.

Study groups in NCT07104032
Study groupRoleWhat they receive
TirabrutinibExperimentalTirabrutinib 480 milligram (mg) orally every day (QD), as monotherapy in 28-day cycles.
Receives: Drug: Tirabrutinib
Rituximab-Temozolomide (R-TMZ)Active comparatorRituximab 375 milligram per square meter (mg/m2) intravenously (IV) and temozolomide 150 mg/m2/day orally, as combination therapy for Cycle 1 through 6 in 28-day cycles.
Receives: Drug: Rituximab; Drug: Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    PFS based on blinded Independent Review Committee (BIRC) assessment according to International Primary Central Nervous System Lymphoma Collaborative Group (IPCG) criteria, defined as time from randomization to progressive disease (PD) or death due to any cause, whichever occurs first.

    Measured: Estimated up to 24 months

Secondary outcomes (12)

  1. Overall Response Rate (ORR)

    ORR based on BIRC per IPCG criteria, defined as the percentage of participants with a best overall response of complete response (CR), unconfirmed complete response (CRu), or partial response (PR).

    Measured: Estimated up to 48 months]

  2. Overall Survival (OS)

    OS defined as time from randomization until death due to any cause.

    Measured: Estimated up to 48 months

  3. Complete Response Rate (CRR)

    CRR based on BIRC per IPCG criteria, defined as the percentage of participants with a best overall response of CR or CRu.

    Measured: Estimated up to 48 months

  4. Best Overall Response (BOR)

    BOR based on BIRC per IPCG criteria, defined as the best response from randomization to the date of PD or the date of initiation of subsequent anticancer therapy for PCNSL, whichever occurs first.

    Measured: Estimated up to 48 months]

  5. Time to Response (TTR)

    TTR based on BIRC per IPCG criteria, defined as time between randomization and the date of first response of CR, CRu, or PR.

    Measured: Estimated up to 48 months

  6. Time to Complete Response (TTCR)

    TTCR based on BIRC per IPCG criteria, defined as the time between randomization and the date of first complete response (CR or CRu).

    Measured: Estimated up to 48 months

  7. Duration of Response (DOR)

    DOR based on BIRC per IPCG criteria, defined as the time between the date of first response (CR, CRu, or PR) and the date of the first PD or date of death due to any cause, whichever occurs first.

    Measured: Estimated up to 48 months

  8. Disease Free Survival (DFS)

    DFS based on BIRC per IPCG criteria, defined as the time between the date of first complete response (CR or CRu) and the date of the first PD, or date of death due to any cause, whichever occurs first.

    Measured: Estimated up to 48 months

  9. Change from Baseline in Corticosteroid Dose

    Measured: Baseline, estimated up to 48 months

  10. Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire Core Module 30 (QLQ-C30) Score

    Measured: Baseline, estimated up to 48 months

  11. Change from Baseline in EORTC Quality of Life Questionnaire Brain Cancer Module (QLQ-BN20) Score

    Measured: Baseline, estimated up to 48 months

  12. Change from Baseline in 5-Level EuroQol 5-Dimensional Questionnaire (EQ-5D-5L) Score

    Measured: Baseline, estimated up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2025
  2. Study start12 Jun 2026
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07104032
Sponsor's protocol ID
ONO-4059-17
Other IDs
2025-523389-26-00, 2025
Acronym
IGNITE
Status last verified
Oct 2026
First submitted
29 Jul 2025
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nayak L, Grommes C, Psoinos C, Reu FJ, Takazawa A, Uttarwar M, Xia B, Carvajal LA, Kim S, Sherman ML, Batchelor TT. IGNITE: a phase III study of tirabrutinib versus rituximab and temozolomide combination therapy in relapsed/refractory primary central nervous system lymphoma. Future Oncol. 2026 Jun;22(15):1751-1757. doi: 10.1080/14796694.2026.2683574. Epub 2026 Jun 19.

    PubMed 42317052

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tirabrutinib, Rituximab and Temozolomide in people with Relapsed/Refractory Primary Central Nervous System Lymphoma, run by Ono Pharmaceutical Co., Ltd. at 42 sites in 7 countries.

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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Italy, Spain, France, Australia and 2 more countries. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Team (888-724-3274, clinicaltrials@deciphera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Estimated up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07104032, which also lists 1 linked publication.

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 28 Oct 2026.

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