NCT04802590 is a Phase 2 clinical trial of Ibrutinib 560 mg in Mantle Cell Lymphoma, sponsored by The Lymphoma Academic Research Organisation.

Who is sponsoring NCT04802590?

NCT04802590 is sponsored by The Lymphoma Academic Research Organisation.

What drugs are being tested in NCT04802590?

Interventions in NCT04802590: Ibrutinib 560 mg, Venetoclax 10 MG Oral Tablet [Venclexta], Venetoclax 50 MG Oral Tablet [Venclexta], Venetoclax 100 MG Oral Tablet [Venclexta].

What condition does NCT04802590 study?

NCT04802590 studies Mantle Cell Lymphoma.

Is NCT04802590 still recruiting?

NCT04802590 is currently active, enrolled. Last updated 4 March 2026.

Last reviewed 2026-03-04 · How we verify

NCT04802590

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Ibrutinib + CD20 Antibody and Venetoclax in Patients With Untreated Mantle Cell Lymphoma

Active, enrolled Phase 2 Last updated 4 March 2026

What this trial tests

Phase 2 trial testing Ibrutinib 560 mg in Mantle Cell Lymphoma in 194 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

24 January 2022

Primary endpoint
31 March 2026

30 September 2031

Quick facts

Lead sponsor	The Lymphoma Academic Research Organisation
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	194
Start date	24 January 2022
Primary completion	31 March 2026
Estimated completion	30 September 2031
Sites	45 locations across Belgium, France, United Kingdom

Drugs / interventions tested

Ibrutinib 560 mg — full drug profile →
Venetoclax 10 MG Oral Tablet [Venclexta] — full drug profile →
Venetoclax 50 MG Oral Tablet [Venclexta] — full drug profile →
Venetoclax 100 MG Oral Tablet [Venclexta] — full drug profile →

Conditions studied

Mantle Cell Lymphoma — all drugs for Mantle Cell Lymphoma →

Sponsor

The Lymphoma Academic Research Organisation — full company profile →

Who can join

Adults 18 to 79, any sex, with Mantle Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The OASIS II trial is a multicentre, open label, randomized phase II trial. We will compare the efficacy of Ibrutinib/anti-CD20 Ab versus Ibrutinib/anti-CD20 Ab/Venetoclax given as fixed duration combinations in newly diagnosed Mantle Cell Lymphoma (MCL) patients (≥ 18 years and \< 80 years of age). Treatment duration of Ibrutinib and Venetoclax will be a maximum of two years. Patients will be treated with CD20 Ab for 3.5 years. The primary aim is to assess MRD status at 6 months in both arms.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Tumor Microenvironment and Immunotherapy-Based Approaches in Mantle Cell Lymphoma.
Saleh K, Cheminant M, Chiron D, Burroni B, et al · · 2022 · cited 18× · PMID 35804999 · DOI 10.3390/cancers14133229
Tipping the balance: toward rational combination therapies to overcome venetoclax resistance in mantle cell lymphoma.
Thus YJ, Eldering E, Kater AP, Spaargaren M. · · 2022 · cited 17× · PMID 35725771 · DOI 10.1038/s41375-022-01627-9
Seven-year outcomes of venetoclax-ibrutinib therapy in mantle cell lymphoma: durable responses and treatment-free remissions.
Handunnetti SM, Anderson MA, Burbury K, Thompson PA, et al · · 2024 · cited 16× · PMID 38662991 · DOI 10.1182/blood.2023023388
Molecular pathology of lymphoma and its treatment strategies: from mechanistic elucidation to precision medicine.
Wang Z, Feng S, Yao X, Zhao R, et al · · 2025 · cited 2× · PMID 40703518 · DOI 10.3389/fimmu.2025.1620895
Your chemo is no good here: management of high-risk MCL.
Sawalha Y, Maddocks K. · · 2024 · cited 1× · PMID 39644043 · DOI 10.1182/hematology.2024000658
Evolving therapeutic strategies in mantle cell lymphoma: advancements and future directions.
Tavarozzi R, Maher N, Catania G, Zacchi G, et al · · 2026 · PMID 41986622 · DOI 10.1038/s41375-026-02942-1

Verify or expand the search:

Other trials of Ibrutinib 560 mg

Trials testing the same drug.

NCT03190330 — A Study to Assess Safety of ImbruvicaTM in Indian Participants With Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma · Phase 4 · completed

Other recruiting trials for Mantle Cell Lymphoma

Currently open trials in the same condition.

NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
NCT06839053 — Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic L · Phase 2 · recruiting
NCT06357676 — Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial · Phase 1, PHASE2 · recruiting
NCT06854003 — BRAZAN: A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Fo · Phase 2 · recruiting

Other The Lymphoma Academic Research Organisation trials

Trials by the same sponsor.

NCT06994169 — Glofitamab in Real Life · recruiting
NCT06592846 — FERtility After Therapy With Intensive Lymphoma in Young Women: LNH-03 1B, LNH-03 2B, LNH-07 3B, GAINED Follow-up · completed
NCT06271057 — Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse · Phase 2 · recruiting
NCT05529524 — Signatures of Response and Resistance to Mosunetuzomab in Follicular Lymphomas (FL) · completed
NCT04974216 — Study of Tafasitamab and Lenalinomide Associated to Rituximab in Frontline Diffuse Large B-Cell Lymphoma Patients of 80 · Phase 2 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04802590 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The Lymphoma Academic Research Organisation
Last refreshed: 4 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04802590.

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