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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05963074
Other study ID # 54179060CLL2032
Secondary ID 2023-504044-34-0
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 31, 2024
Est. completion date March 19, 2029

Study information

Verified date June 2024
Source Janssen Research & Development, LLC
Contact Study Contact
Phone 844-434-4210
Email Participate-In-This-Study@its.jnj.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 320
Est. completion date March 19, 2029
Est. primary completion date September 29, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL) as per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 diagnostic criteria - For ibruinib + venetocIax (I+V) cohorts: eastern cooperative oncology group (ECOG) performance status of 0-1. For ibrutinib monotherapy cohorts: ECOG performance status of 0-2 - Measurable nodal disease by computed tomography (CT), defined as at least 1 lymph node greater than and equal to (>=) 1.5 centimeters (cm) in longest diameter - A participant using oral contraceptives must use an additional contraceptive method - A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or until 1 month after last dose or per local label if more conservative (for example, 3 months in European Union or Canada and 1 month in United States) Exclusion Criteria: - Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura, such as those participants with a declining hemoglobin level or platelet count secondary to autoimmune destruction within the 4 weeks prior to first dose of study treatment, or the need for prednisone greater than (>) 20 milligrams (mg) daily (or corticosteroid equivalent) to treat or control the autoimmune disease - Known bleeding disorders (example, von Willebrand's disease or hemophilia) - Stroke or intracranial hemorrhage within 6 months prior to enrollment - Known or suspected Richter's transformation or central nervous system (CNS) involvement - Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class II, III, or IV congestive heart failure as defined by the New York Heart Association Functional Classification

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ibrutinib
Ibrutinib capsules will be administered orally.
Venetoclax
Venetoclax tablets will be administered orally.

Locations

Country Name City State
Canada QEII Health Sciences Centre Halifax Nova Scotia
Canada Niagara Health System St. Catharines Ontario
Czechia Fakultni nemocnice Brno Brno - Bohunice
Czechia Fakultni nemocnice Hradec Kralove Hradec Kralove
Czechia Fakultni nemocnice Olomouc Olomouc
Czechia Fakultni nemocnice Ostrava Ostrava - Poruba
Czechia Fakultni nemocnice Kralovske Vinohrady Praha 10
Czechia Ustav Hematologie A Krevni Transfuze Praha 2
France CHU Nantes Nantes Cedex 1
Italy Azienda Ospedaliero Universitaria Careggi Firenze
Italy Ospedale San Raffaele Milano
Italy Ospedale Maggiore della Carita Novara
Italy Ospedale Villa Sofia-Cervello Palermo
Italy Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia Perugia
Italy Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore Roma
Poland Wojewodzki Szpital Specjalistyczny Biala Podlaska
Poland Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza Brzozow
Poland Szpitale Pomorskie Sp z o o Gdynia
Poland Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach Kielce
Poland Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie Krakow
Poland Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi Lodz
Poland Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli Lublin
Spain Hosp Reina Sofia Cordoba
Spain Hosp. Univ. 12 de Octubre Madrid
Spain Hosp. Univ. Marques de Valdecilla Santander
United States The Oncology Institute Clinical Research Cerritos California
United States Oncology Hematology Care Cincinnati Ohio
United States Willamette Valley Cancer Institute and Research Center Eugene Oregon
United States Hunterdon Hematology Oncology Flemington New Jersey
United States Texas Oncology-Fort Worth Cancer Center Fort Worth Texas
United States Virginia Cancer Specialists Gainesville Virginia
United States Southeastern Medical Oncology Center Goldsboro North Carolina
United States Grand Valley Oncology Grand Junction Colorado
United States Hope and Healing Cancer Services Hinsdale Illinois
United States Iowa City VA Health Care System Iowa City Iowa
United States Research Medical Center Kansas City Missouri
United States Mount Sinai Medical Center Campus Miami Beach Florida
United States Minnesota Oncology Hematology, P.A. Minneapolis Minnesota
United States Hematology Oncology Associates of Rockland Nyack New York
United States Community Cancer Trials of Utah Ogden Utah
United States SLO Oncology and Hematology Health Center San Luis Obispo California
United States Providence Medical Foundation Santa Rosa California
United States VA Puget Sound Healthcare System Seattle Washington
United States Springfield Clinic Springfield Illinois
United States Texas Oncology-Gulf Coast The Woodlands Texas
United States Northwest Cancer Specialists PC Vancouver Washington
United States Virginia Oncology Associates Virginia Beach Virginia
United States PIH Health Hospital Whittier California

Sponsors (2)

Lead Sponsor Collaborator
Janssen Research & Development, LLC Pharmacyclics LLC.

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  France,  Italy,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Best Overall Response Rate (ORR) 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. Up to 5 years
Secondary Complete Response (CR) Rate CR rate is defined as the percentage of participants achieving a best overall response of CR or CRi per iwCLL 2018 criteria as assessed by investigator. Up to 5 years
Secondary Duration of Response (DOR) DOR is defined as the duration in days from the date of initial documentation of PR or better to the date of first documented evidence of PD or death. Up to 5 years
Secondary Progression Free Survival (PFS) PFS by investigator assessment is defined as the duration from date of randomization to date of PD or death due to any cause, whichever occurs first. Up to 5 years
Secondary Overall Survival (OS) OS is defined as the time from date of randomization to date of death from any cause. Up to 5 years
Secondary Cohorts 1a and 1b: Minimal Residual Disease (MRD) Negative Rate MRD-negative rate is defined as the percentage of participants who reach MRD-negative status (that is, less than [<] 1 chronic lymphocytic leukemia (CLL) cell per 10,000 leukocytes or <0.01 percentage [%]) in the peripheral blood. Up to 5 years
Secondary Number of Participants with Adverse Events (AEs) An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Up to 5 years
Secondary Number of Participants with AEs by Severity An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. Up to 5 years
Secondary Percentage of Participants with Rate of Discontinuation due to AEs Percentage of participants with rate of discontinuation due to AEs will be reported. Up to 5 years
Secondary Percentage of Participants with Dose Reduction due AEs Percentage of participants with dose reduction due AEs will be reported. Up to 5 years
Secondary Adherence Rates The adherence rate is defined as the percentage of total dose taken over the total dose prescribed. Up to 5 years
Secondary Duration of Treatment Duration of treatment is defined as the time period in days between the date of first study treatment administration and date of last administration. Up to 5 years
Secondary Time to Worsening as Measured by EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Time to worsening is defined as time interval (months) from randomization to first observation of deterioration. Time to worsening as measured by EQ-5D-5L will be reported. Up to 5 years
Secondary Time to Worsening as Measured by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ)-C30) Time to worsening is defined as time interval from randomization to first observation of deterioration. Time to worsening as measured by EORTC QLQ-C30 will be reported. Up to 5 years
Secondary Time to Worsening as Measured by EORTC QLQ-CLL17 Time to worsening is defined as time interval from randomization to first observation of deterioration. Time to worsening as measured by EORTC QLQ-CLL17 will be reported. Up to 5 years
Secondary Time to Worsening as Measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score Time to Worsening is defined as time interval (months) from randomization to first observation of deterioration. Time to worsening as measured by FACIT-fatigue total score will be reported. Up to 5 years
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