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| ID | Type | Description | Link |
|---|---|---|---|
| 54179060CLL2032 | Other Identifier | Janssen Research & Development, LLC | |
| 2023-504044-34-00 | Registry Identifier | EUCT number |
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| Name | Class |
|---|---|
| Pharmacyclics LLC. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1a: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax | Experimental | Participants will receive ibrutinib 420 milligrams (mg) capsule every day (QD) for a lead-in of 3 cycles (1 cycle = 28 days). From Cycle 4, venetoclax 400 mg tablet dose ramp-up (from 20 to 400 mg over 5 weeks) will begin, and venetoclax 400 mg QD will be administered with ibrutinib 420 mg QD, orally for 12 cycles through Cycle 15. |
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| Cohort 1b: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax | Experimental | Participants will receive ibrutinib 420 mg capsule QD for a lead-in of 3 cycles (1 cycle = 28 days). From Cycle 4, venetoclax 400 mg tablet dose ramp-up (from 20 to 400 mg over 5 weeks) will begin and ibrutinib dose will be reduced to 280 mg and will be administered QD, venetoclax 400 mg tablets QD will be administered with ibrutinib 280 mg for 12 cycles through Cycle 15. |
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| Cohort 2a: Continuous Ibrutinib Monotherapy | Experimental | Participants will receive ibrutinib 420 mg QD (or last tolerated dose) until disease progression (PD) or unacceptable toxicity. |
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| Cohort 2b: Continuous Ibrutinib Monotherapy | Experimental | Participants will receive ibrutinib 420 mg QD for 1 cycle (1 cycle = 28 days) followed by Ibrutinib 280 mg QD (or last tolerated dose) and continue until disease progression or unacceptable toxicity. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib capsules will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Oncology Institute Clinical Research | Recruiting | Cerritos | California | 90703 | United States | |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Venetoclax | Drug | Venetoclax tablets will be administered orally. |
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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 |
| 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 |
| Overall Survival (OS) | OS is defined as the time from date of randomization to date of death from any cause. | Up to 5 years |
| 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 |
| 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 |
| 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 |
| 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 |
| Percentage of Participants with Dose Reduction due AEs | Percentage of participants with dose reduction due AEs will be reported. | Up to 5 years |
| Adherence Rates | The adherence rate is defined as the percentage of total dose taken over the total dose prescribed. | Up to 5 years |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Cancer and Blood Specialty Clinic |
| Recruiting |
| Los Alamitos |
| California |
| 90720 |
| United States |
| SLO Oncology and Hematology Health Center | Recruiting | San Luis Obispo | California | 93401 | United States |
| Providence Medical Foundation | Recruiting | Santa Rosa | California | 95403 | United States |
| PIH Health Hospital | Recruiting | Whittier | California | 90602 | United States |
| Grand Valley Oncology | Recruiting | Grand Junction | Colorado | 81505 | United States |
| Mount Sinai Medical Center Campus | Recruiting | Miami Beach | Florida | 33140-2948 | United States |
| The Oncology Institute | Recruiting | North Miami Beach | Florida | 33169 | United States |
| Mid Florida Hematology Oncology | Recruiting | Orange | Florida | 32763 | United States |
| Boise VA Medical Center | Recruiting | Boise | Idaho | 83702 | United States |
| Hope and Healing Cancer Services | Recruiting | Hinsdale | Illinois | 60521 | United States |
| Springfield Clinic | Recruiting | Springfield | Illinois | 62702 | United States |
| Iowa City VA Health Care System | Recruiting | Iowa City | Iowa | 52246 | United States |
| Minnesota Oncology Hematology P A | Recruiting | Minneapolis | Minnesota | 55404 | United States |
| Research Medical Center | Recruiting | Kansas City | Missouri | 64132 | United States |
| Hunterdon Hematology Oncology | Recruiting | Flemington | New Jersey | 08822 | United States |
| Summit Medical Group | Completed | Florham Park | New Jersey | 07932 | United States |
| Hematology Oncology Associates of Rockland | Recruiting | Nyack | New York | 10960 | United States |
| Southeastern Medical Oncology Center | Completed | Goldsboro | North Carolina | 27534 | United States |
| Oncology Hematology Care | Recruiting | Cincinnati | Ohio | 45242 | United States |
| Willamette Valley Cancer Institute and Research Center | Recruiting | Eugene | Oregon | 97401 | United States |
| OHSU Knight Cancer Institute | Recruiting | Portland | Oregon | 97239 | United States |
| Renovatio Clinical | Completed | El Paso | Texas | 79915 | United States |
| Texas Oncology-Fort Worth Cancer Center | Recruiting | Fort Worth | Texas | 76104 | United States |
| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Renovatio Clinical 1 | Completed | The Woodlands | Texas | 77380 | United States |
| Texas Oncology-Gulf Coast | Recruiting | The Woodlands | Texas | 77380 | United States |
| Community Cancer Trials of Utah | Recruiting | Ogden | Utah | 84405 | United States |
| Virginia Cancer Specialists | Recruiting | Manassas | Virginia | 20110 | United States |
| Virginia Oncology Associates | Recruiting | Virginia Beach | Virginia | 23456 | United States |
| VA Puget Sound Healthcare System | Recruiting | Seattle | Washington | 98108 | United States |
| Northwest Cancer Specialists PC | Recruiting | Vancouver | Washington | 98684 | United States |
| QEII Health Sciences Centre | Recruiting | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Niagara Health System | Recruiting | St. Catharines | Ontario | L2S 0A9 | Canada |
| Fakultni nemocnice Brno | Recruiting | Brno-Bohunice | 625 00 | Czechia |
| Fakultni nemocnice Hradec Kralove | Recruiting | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Olomouc | Recruiting | Olomouc | 779 00 | Czechia |
| Fakultni Nemocnice Ostrava | Recruiting | Ostrava - Poruba | 708 52 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Recruiting | Prague | 100 34 | Czechia |
| Ustav Hematologie A Krevni Transfuze | Recruiting | Prague | 128 00 | Czechia |
| CHU de Clermont Ferrand | Completed | Clermont-Ferrand | 63100 | France |
| CHU Nantes | Recruiting | Nantes | 44000 | France |
| Hopital Pitie Salpetriere | Recruiting | Paris | 75651 | France |
| CHU Lyon Sud | Recruiting | Pierre-Bénite | 69495 | France |
| CHU de Reims | Recruiting | Reims | 51100 | France |
| Institut de Cancerologie Strasbourg Europe ICANS | Completed | Strasbourg | 67200 | France |
| Semmelweis Egyetem | Recruiting | Budapest | 1088 | Hungary |
| Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz | Recruiting | Győr | 9024 | Hungary |
| Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz | Recruiting | Nyíregyháza | 4400 | Hungary |
| University of Szeged | Recruiting | Szeged | 6725 | Hungary |
| U.O. Ematologia Istituto Tumori Giovanni Paolo II | Recruiting | Bari | 70124 | Italy |
| Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant Anna | Recruiting | Ferrara | 44124 | Italy |
| Azienda Ospedaliero Universitaria Careggi | Recruiting | Florence | 50134 | Italy |
| Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Recruiting | Milan | 20162 | Italy |
| Ospedale Maggiore della Carita | Recruiting | Novara | 28100 | Italy |
| Universita degli Studi di Padova Azienda Ospedaliera di Pa | Recruiting | Padova | 35129 | Italy |
| Ospedale Villa Sofia-Cervello | Recruiting | Palermo | 90146 | Italy |
| Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia | Recruiting | Perugia | 06132 | Italy |
| Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore | Recruiting | Roma | 00136 | Italy |
| Umberto I Policlinico di Roma | Recruiting | Roma | 00161 | Italy |
| Wojewodzki Szpital Specjalistyczny | Recruiting | Biała Podlaska | 21 500 | Poland |
| Szpital Specjalistyczny w Brzozowie | Recruiting | Brzozów | 36 200 | Poland |
| Szpitale Pomorskie Sp z o o | Recruiting | Gdynia | 81-519 | Poland |
| Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach | Recruiting | Kielce | 25 734 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie | Recruiting | Krakow | 30 688 | Poland |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi | Recruiting | Lodz | 93 513 | Poland |
| Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli | Recruiting | Lublin | 20 090 | Poland |
| Hosp Univ Vall D Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hosp Reina Sofia | Recruiting | Córdoba | 14004 | Spain |
| Hosp. Univ. Ramon Y Cajal | Recruiting | Madrid | 28034 | Spain |
| Hosp. Univ. 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hosp. Univ. Marques de Valdecilla | Recruiting | Santander | 39008 | Spain |
| Hosp. Clinico Univ. de Santiago | Recruiting | Santiago de Compostela | 15706 | Spain |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C551803 | ibrutinib |
| C579720 | venetoclax |
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