NCT04212013 is a Phase 3 clinical trial of Ibrutinib in Marginal Zone Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center.

Who is sponsoring NCT04212013?

NCT04212013 is sponsored by Memorial Sloan Kettering Cancer Center.

What drugs are being tested in NCT04212013?

Interventions in NCT04212013: Ibrutinib, Rituximab, Placebo.

What condition does NCT04212013 study?

NCT04212013 studies Marginal Zone Lymphoma.

Is NCT04212013 still recruiting?

NCT04212013 is currently active, enrolled. Last updated 23 July 2025.

Last reviewed 2025-07-23 · How we verify

NCT04212013

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

A Study of Ibrutinib With Rituximab in People With Untreated Marginal Zone Lymphoma

Active, enrolled Phase 3 Last updated 23 July 2025

What this trial tests

Phase 3 trial testing Ibrutinib in Marginal Zone Lymphoma in 23 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

23 December 2019

Primary endpoint
18 March 2027

18 March 2027

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	23
Start date	23 December 2019
Primary completion	18 March 2027
Estimated completion	18 March 2027
Sites	10 locations across United States

Drugs / interventions tested

Ibrutinib (ibrutinib) — full drug profile →
Rituximab — full drug profile →
Placebo

Conditions studied

Marginal Zone Lymphoma — all drugs for Marginal Zone Lymphoma →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Marginal Zone Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to see if the combination of rituximab and ibrutinib can help people with marginal zone lymphoma who have not received treatment in the past. The study will also compare the combination of rituximab and ibrutinib with the combination of rituximab and placebo to see which combination works better.

Publications & conference data

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

Metabolic Reprogramming and Potential Therapeutic Targets in Lymphoma.
Pang Y, Lu T, Xu-Monette ZY, Young KH. · · 2023 · cited 16× · PMID 36982568 · DOI 10.3390/ijms24065493
Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of lymphoma.
Neelapu SS, Adkins S, Ansell SM, Brody J, et al · · 2020 · cited 12× · PMID 33361336 · DOI 10.1136/jitc-2020-001235
Management of marginal zone lymphomas.
Merli M, Arcaini L. · · 2022 · cited 10× · PMID 36485086 · DOI 10.1182/hematology.2022000362
Novel Therapies for Follicular Lymphoma and Other Indolent Non-Hodgkin Lymphomas.
Leslie LA. · · 2021 · cited 7× · PMID 34694508 · DOI 10.1007/s11864-021-00909-1
Outcomes of marginal zone lymphoma treated with ibrutinib in the first-line setting in the United States: a real-world analysis.
Epperla N, Zhao Q, Moyo T, Watkins MP, et al · · 2024 · cited 1× · PMID 38091577 · DOI 10.1182/bloodadvances.2023011698

Verify or expand the search:

Other trials of Ibrutinib

Trials testing the same drug.

NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
NCT07052695 — Mosunetuzumab for CLL MRD Clearance · Phase 1, PHASE2 · recruiting
NCT06649812 — Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggress · Phase 2 · recruiting
NCT07169565 — Ibrutinib Followed by BR (Bendamustine and Rituximab) as a Time-Limited Therapy for Waldenström Macroglobulinemia · Phase 1 · not yet recruiting
NCT06357676 — Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial · Phase 1, PHASE2 · recruiting

Other recruiting trials for Marginal Zone Lymphoma

Currently open trials in the same condition.

NCT06796998 — Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL) · Phase 2 · recruiting
NCT06792825 — HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL · Phase 2 · recruiting
NCT06860880 — Combating Cancer-Related Fatigue: A Personalized Supportive Care Program · NA · recruiting
NCT06636175 — 64Cu-LLP2A for Imaging Hematologic Malignancies · EARLY_PHASE1 · recruiting
NCT06563596 — Epco, Zanu, Ritux for R/R FL or MZL · Phase 2 · recruiting

Other Memorial Sloan Kettering Cancer Center trials

Trials by the same sponsor.

NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT07507643 — A Study of Methylprednisolone in People Having Liver Surgery · Phase 3 · recruiting
NCT07483307 — A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer · Phase 2 · recruiting
NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term · Phase 2 · recruiting
NCT07449195 — A Study Comparing Two Optical Coherence Tomography Devices in People With Ocular Tumors · NA · 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 NCT04212013 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 Memorial Sloan Kettering Cancer Center
Last refreshed: 23 July 2025

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/NCT04212013.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing