CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Ibrutinibdrug
Likely dose
Ibrutinib 420 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03207555
NCT03207555Phase 2Completed

Ibrutinib Monotherapy in Early Stage Chronic Lymphocytic Leukemia (CLL) Without IWCLL/NCI-WG 2008 Treatment Indications But With High-Risk Features for Disease Progression

M.D. Anderson Cancer Center·interventional·Posted Jul 2, 2017·Updated Sep 2, 2025

In Brief

A Phase 2 clinical trial evaluating Ibrutinib for Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic and 2 related conditions. Completed, enrolled 23 participants across 1 site.

Detailed Summary

The standard approach to managing chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) is to wait until you have symptoms before treatment is given. The goal of this clinical research study is to learn if providing earlier treatment for CLL or SLL with ibrutinib in patients who do not have symptoms will be more effective than waiting until symptoms develop. This is an investigational study. Ibrutinib is FDA approved and commercially available for the treatment of patients with CLL or SLL. It is considered investigational to give ibrutinib to CLL and SLL patients before symptoms develop. The study doctor can describe how the study drug is designed to work. Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPharmacyclics LLC.

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 2, 2017
Enrollment StartMay 23, 2018
Primary CompletionAug 2, 2024
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 9 years ago

Interventions

Ibrutinibdrug

420 mg by mouth once daily.