NCT07448324 is a Phase 2 clinical trial of Orelabrutinib in Marginal Zone Lymphoma(MZL), sponsored by The First Affiliated Hospital with Nanjing Medical University.

Who is sponsoring NCT07448324?

NCT07448324 is sponsored by The First Affiliated Hospital with Nanjing Medical University.

What drugs are being tested in NCT07448324?

Interventions in NCT07448324: Orelabrutinib, Rituximab, Lenalidomide.

What condition does NCT07448324 study?

NCT07448324 studies Marginal Zone Lymphoma(MZL).

Is NCT07448324 still recruiting?

NCT07448324 is currently recruiting now. Last updated 4 March 2026.

Last reviewed 2026-03-04 · How we verify

NCT07448324

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

Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL

Recruiting now Phase 2 Last updated 4 March 2026

What this trial tests

Phase 2 trial testing Orelabrutinib in Marginal Zone Lymphoma(MZL) in 50 participants. Currently enrolling.

Timeline

1 April 2025

Primary endpoint
1 January 2028

1 January 2030

Quick facts

Lead sponsor	The First Affiliated Hospital with Nanjing Medical University
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 April 2025
Primary completion	1 January 2028
Estimated completion	1 January 2030
Sites	1 location across China

Drugs / interventions tested

Orelabrutinib — full drug profile →
Rituximab — full drug profile →
Lenalidomide — full drug profile →

Conditions studied

Marginal Zone Lymphoma(MZL) — all drugs for Marginal Zone Lymphoma(MZL) →

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Who can join

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

Sponsor's own description

This is a prospective, single-arm, phase II study aimed at evaluating the safety and efficacy of orelabrutinib combined with rituximab ± lenalidomide in response-adapted stratified therapy for untreated marginal zone lymphoma. The primary endpoint is the complete response rate (CRR).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Orelabrutinib

Trials testing the same drug.

NCT07400250 — Phase II Study of Orelabrutinib in Combination With Romiplostim N01 in Patients With Primary Immune Thrombocytopenia (IT · Phase 2 · not yet recruiting
NCT07410520 — PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL. · Phase 2 · recruiting
NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
NCT07499271 — Genetic Subtype-matched Targeted Therapy for the Treatment of Newly Diagnosed DLBCL With TP53 Mutation · Phase 2 · recruiting
NCT07355699 — Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma · Phase 4 · recruiting

Other recruiting trials for Marginal Zone Lymphoma(MZL)

Currently open trials in the same condition.

NCT07355699 — Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma · Phase 4 · recruiting
NCT07480863 — Treatment of Orelabrutinib+Hi-CVP Regimen for Previously Untreated MZL · Phase 2 · active not recruiting
NCT07247383 — Orelabrutinib Plus Low-Dose Radiotherapy Or Rituximab For Ocular Adnexal MALT Lymphoma · Phase 2 · active not recruiting
NCT07208981 — Orelabrutinib Combined With Zebetuzumab and Lenalidomide for the Treatment of Newly Diagnosed MZL · Phase 2 · recruiting
NCT07022223 — Orelabrutinib Combined With Rituximab as First-line Systemic Treatment for Marginal Zone Lymphoma · Phase 2 · recruiting

Other The First Affiliated Hospital with Nanjing Medical University trials

Trials by the same sponsor.

NCT07377981 — An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyp · Phase 4 · not yet recruiting
NCT07523789 — Comparison of Chemotherapy and Immunotherapy in Neoadjuvant Therapy for TNBC · not yet recruiting
NCT07464756 — SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer · Phase 2 · not yet recruiting
NCT07482826 — Full-Endoscopic Decompression vs. Endoscopic Lumbar Fusion for Middle-Aged and Older Adults With Spinal Stenosis · NA · not yet recruiting
NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · 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 NCT07448324 (US National Library of Medicine, public domain)
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 First Affiliated Hospital with Nanjing Medical University
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/NCT07448324.

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