A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia
Condition(s) studied
Investigational drug(s) / intervention(s)
Ibrutinib: Ibrutinib capsules will be administered orally.
Venetoclax: Venetoclax tablets will be administered orally.
Study summary
The purpose of this study is to evaluate the efficacy and safety of ibrutinib + venetoclax (I+V) and ibrutinib monotherapy regimens in which dosing of ibrutinib is either proactively reduced or reactively modified in response to adverse events (AEs).
Eligibility
Primary outcome measure(s)
- Best Overall Response Rate (ORR) — Up to 5 years
Best ORR is defined as the percentage of participants who achieve complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria as assessed by investigator.
Trial sites (74)
| Facility | City | Region | Status |
|---|---|---|---|
| The Oncology Institute Clinical Research | Cerritos | California | |
| Cancer and Blood Specialty Clinic | Los Alamitos | California | |
| SLO Oncology and Hematology Health Center | San Luis Obispo | California | |
| Providence Medical Foundation | Santa Rosa | California | |
| PIH Health Hospital | Whittier | California | |
| Grand Valley Oncology | Grand Junction | Colorado | |
| Mount Sinai Medical Center Campus | Miami Beach | Florida | |
| The Oncology Institute | North Miami Beach | Florida | |
| Mid Florida Hematology Oncology | Orange | Florida | |
| Boise VA Medical Center | Boise | Idaho | |
| Hope and Healing Cancer Services | Hinsdale | Illinois | |
| Springfield Clinic | Springfield | Illinois | |
| Iowa City VA Health Care System | Iowa City | Iowa | |
| Minnesota Oncology Hematology P A | Minneapolis | Minnesota | |
| Research Medical Center | Kansas City | Missouri | |
| Hunterdon Hematology Oncology | Flemington | New Jersey | |
| Summit Medical Group | Florham Park | New Jersey | |
| Hematology Oncology Associates of Rockland | Nyack | New York | |
| Southeastern Medical Oncology Center | Goldsboro | North Carolina | |
| Oncology Hematology Care | Cincinnati | Ohio | |
| Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | |
| OHSU Knight Cancer Institute | Portland | Oregon | |
| Renovatio Clinical | El Paso | Texas | |
| Texas Oncology-Fort Worth Cancer Center | Fort Worth | Texas | |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | |
| Renovatio Clinical 1 | The Woodlands | Texas | |
| Texas Oncology-Gulf Coast | The Woodlands | Texas | |
| Community Cancer Trials of Utah | Ogden | Utah | |
| Virginia Cancer Specialists | Manassas | Virginia | |
| Virginia Oncology Associates | Virginia Beach | Virginia | |
| VA Puget Sound Healthcare System | Seattle | Washington | |
| Northwest Cancer Specialists PC | Vancouver | Washington | |
| QEII Health Sciences Centre | Halifax | Nova Scotia | |
| Niagara Health System | St. Catharines | Ontario | |
| Fakultni nemocnice Brno | Brno-Bohunice | Czechia | |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | Czechia | |
| Fakultni nemocnice Olomouc | Olomouc | Czechia | |
| Fakultni Nemocnice Ostrava | Ostrava - Poruba | Czechia | |
| Fakultni nemocnice Kralovske Vinohrady | Prague | Czechia | |
| Ustav Hematologie A Krevni Transfuze | Prague | Czechia |
+ 34 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05963074 on ClinicalTrials.gov ↗ ← All trials in France