NCT02232386 (LLC1114) is a Phase 2 clinical trial of Ibrutinib in Chronic Lymphocyte Leukemia, sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto.

Who is sponsoring NCT02232386?

NCT02232386 is sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto.

What drugs are being tested in NCT02232386?

Interventions in NCT02232386: Ibrutinib, Rituximab.

What condition does NCT02232386 study?

NCT02232386 studies Chronic Lymphocyte Leukemia, Adult Patients.

Is NCT02232386 still recruiting?

NCT02232386 is currently completed. Last updated 15 January 2025.

Last reviewed 2025-01-15 · How we verify

NCT02232386: LLC1114

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

A Phase 2 Multicenter Study to Assess the Activity and the Safety of Front-line Ibrutinib Plus Rituximab (IR) in Unfit Patients With Chronic Lymphocytic Leukemia (CLL).

Completed Phase 2 Last updated 15 January 2025

What this trial tests

Phase 2 trial testing Ibrutinib in Chronic Lymphocyte Leukemia in 156 participants. Completed in 16 April 2024.

Timeline

2 March 2015

Primary endpoint
1 April 2018

16 April 2024

Quick facts

Lead sponsor	Gruppo Italiano Malattie EMatologiche dell'Adulto
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	156
Start date	2 March 2015
Primary completion	1 April 2018
Estimated completion	16 April 2024
Sites	36 locations across Italy

Drugs / interventions tested

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

Conditions studied

Chronic Lymphocyte Leukemia — all drugs for Chronic Lymphocyte Leukemia →
Adult Patients — all drugs for Adult Patients →

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto — full company profile →

Who can join

18 and older, any sex, with Chronic Lymphocyte Leukemia or Adult Patients. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of patients on progression-free survival
Time frame: At 12 months from treatment start
To estimate Progression-Free Survival (PFS) at 12 months in patients treated with Ibrutinib plus Rituximab combination in unfit patients with CLL.

Sponsor's own description

The present study aims at evaluating whether treatment with two different drugs, Ibrutinib and Rituximab is both efficient and safe for newly diagnosed patients with chronic lymphocytic leukemia.

Publications & conference data

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

TH2/TH1 Shift Under Ibrutinib Treatment in Chronic Lymphocytic Leukemia.
Puzzolo MC, Del Giudice I, Peragine N, Mariglia P, et al · · 2021 · cited 22× · PMID 33937038 · DOI 10.3389/fonc.2021.637186
Efficacy of Front-Line Ibrutinib and Rituximab Combination and the Impact of Treatment Discontinuation in Unfit Patients with Chronic Lymphocytic Leukemia: Results of the Gimema LLC1114 Study.
Mauro FR, Paoloni F, Molica S, Reda G, et al · · 2021 · cited 5× · PMID 35008372 · DOI 10.3390/cancers14010207
The importance of <i>TP53</i> status in cancer therapy: The example of chronic lymphocytic leukemia.
Mirgayazova R, Khadiullina R, Gilyazova E, Davletshin D, et al · · 2025 · cited 1× · PMID 40321704 · DOI 10.22099/mbrc.2025.51477.2054
47° Congress of the Italian Society of Hematology Rome, Italy, October 7-9, 2019
· 2019

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 Gruppo Italiano Malattie EMatologiche dell'Adulto trials

Trials by the same sponsor.

NCT07356960 — Evaluation of the Efficacy of Ponatinib in Ph+ ALL in the Real-world · not yet recruiting
NCT07158294 — Identification of BCR::ABL1 Mutations by Digital PCR in CML · NA · not yet recruiting
NCT07249606 — Momelotinib Effectiveness in Myelofibrosis · not yet recruiting
NCT06880601 — Teclistamab Plus Autologous Lymphocyte Infusion (ALI) for the Treatment of R/R Multiple Myeloma · Phase 2 · not yet recruiting
NCT06657846 — HRQoL and Financial Toxicity in Patients With VEXAS Syndrome · 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 NCT02232386 (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 Gruppo Italiano Malattie EMatologiche dell'Adulto
Last refreshed: 15 January 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/NCT02232386.

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