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My Saved Trials

A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia (TAILOR)

Last Updated   May 14, 2025

Want to learn how to participate in this trial?

54179060CLL2032

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 2
    2
  • Sites
    74 Sites
  • Status
    Recruiting

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).

CONDITIONS

  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Small Lymphocytic Lymphoma

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


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

More...

DETAILS

LOCATIONS

Locations in:
United States, Canada, Czechia, France, Hungary, Italy, Poland, Spain
Country (8) City or Province (74) Status
United States Cerritos The Oncology Institute Clinical Research
RECRUITING
United States San Luis Obispo SLO Oncology and Hematology Health Center
RECRUITING
United States Santa Rosa Providence Medical Foundation
RECRUITING
United States Whittier PIH Health Hospital
RECRUITING
United States Grand Junction Grand Valley Oncology
RECRUITING
United States Miami Beach Mount Sinai Medical Center Campus
RECRUITING
United States Hinsdale Hope and Healing Cancer Services
RECRUITING
United States Springfield Springfield Clinic
RECRUITING
United States Iowa City Iowa City VA Health Care System
RECRUITING
United States Kansas City Research Medical Center
RECRUITING
United States Flemington Hunterdon Hematology Oncology
RECRUITING
United States Nyack Hematology Oncology Associates of Rockland
RECRUITING
United States Cincinnati Oncology Hematology Care
RECRUITING
United States Eugene Willamette Valley Cancer Institute and Research Center
RECRUITING
United States Fort Worth Texas Oncology-Fort Worth Cancer Center
RECRUITING
United States The Woodlands Texas Oncology-Gulf Coast
RECRUITING
United States Ogden Community Cancer Trials of Utah
RECRUITING
United States Virginia Beach Virginia Oncology Associates
RECRUITING
United States Seattle VA Puget Sound Healthcare System
RECRUITING
United States Vancouver Northwest Cancer Specialists PC
RECRUITING
Canada Halifax QEII Health Sciences Centre
RECRUITING
Canada St. Catharines Niagara Health System
RECRUITING
Czechia Brno - Bohunice Fakultni nemocnice Brno
RECRUITING
Czechia Hradec Kralove Fakultni nemocnice Hradec Kralove
RECRUITING
Czechia Olomouc Fakultni nemocnice Olomouc
RECRUITING
Czechia Ostrava - Poruba Fakultni Nemocnice Ostrava
RECRUITING
Czechia Praha 10 Fakultni nemocnice Kralovske Vinohrady
RECRUITING
Czechia Praha 2 Ustav Hematologie A Krevni Transfuze
RECRUITING
France Clermont-Ferrand CHU de Clermont Ferrand
RECRUITING
France Nantes Cedex 1 CHU Nantes
RECRUITING
France Paris cedex 13 Hopital Pitie Salpetriere
RECRUITING
France Pierre-Benite CHU Lyon Sud
RECRUITING
France Reims CHU de Reims
RECRUITING
France Strasbourg Institut de Cancerologie Strasbourg Europe ICANS
RECRUITING
Hungary Budapest Semmelweis Egyetem
RECRUITING
Hungary Gyor Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
RECRUITING
Hungary Nyiregyhaza Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
RECRUITING
Italy Ferrara Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant Anna
RECRUITING
Italy Firenze Azienda Ospedaliero Universitaria Careggi
RECRUITING
Italy Milano Ospedale San Raffaele
RECRUITING
Italy Novara Ospedale Maggiore della Carita
RECRUITING
Italy Palermo Ospedale Villa Sofia-Cervello
RECRUITING
Italy Perugia Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
RECRUITING
Italy Roma Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
RECRUITING
Italy Roma Umberto I Policlinico di Roma
RECRUITING
Poland Biala Podlaska Wojewodzki Szpital Specjalistyczny
RECRUITING
Poland Gdynia Szpitale Pomorskie Sp z o o
RECRUITING
Spain Barcelona Hosp Univ Vall D Hebron
RECRUITING
Spain Cordoba Hosp Reina Sofia
RECRUITING
Spain Madrid Hosp. Univ. 12 de Octubre
RECRUITING
Spain Santander Hosp. Univ. Marques de Valdecilla
RECRUITING
Spain Santiago de Compostela Hosp. Clinico Univ. de Santiago
RECRUITING
United States Los Alamitos Cancer and Blood Specialty Clinic
RECRUITING
United States North Miami Beach The Oncology Institute
RECRUITING
United States Orange Mid Florida Hematology Oncology
RECRUITING
United States Boise Boise VA Medical Center
RECRUITING
United States Minneapolis Minnesota Oncology Hematology P A
RECRUITING
United States Florham Park Summit Medical Group
COMPLETED
United States Portland OHSU Knight Cancer Institute
RECRUITING
United States El Paso Renovatio Clinical
RECRUITING
United States Houston The University of Texas MD Anderson Cancer Center
RECRUITING
United States The Woodlands Renovatio Clinical
RECRUITING
United States Manassas Virginia Cancer Specialists
RECRUITING
Hungary Szeged University of Szeged
RECRUITING
Italy Bari U.O. Ematologia Istituto Tumori Giovanni Paolo II
RECRUITING
Italy Milano ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Italy Padova Universita degli Studi di Padova Azienda Ospedaliera di Pa
RECRUITING
Poland Brzozow Szpital Specjalistyczny w Brzozowie
RECRUITING
Poland Kielce Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
RECRUITING
Poland Krakow Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
RECRUITING
Poland Lodz Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
RECRUITING
Poland Lublin Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
RECRUITING
Spain Madrid Hosp. Univ. Ramon Y Cajal
RECRUITING
United States Goldsboro Southeastern Medical Oncology Center
COMPLETED
Show More
Geo Locations

33.85835, -118.06479

35.28275, -120.65962

38.44047, -122.71443

33.97918, -118.03284

39.06387, -108.55065

25.79065, -80.13005

41.80086, -87.93701

39.80172, -89.64371

41.66113, -91.53017

39.09973, -94.57857

40.51233, -74.85933

41.09065, -73.91791

39.12713, -84.51435

44.05207, -123.08675

32.72541, -97.32085

30.15799, -95.48938

41.223, -111.97383

36.85293, -75.97799

47.60621, -122.33207

45.63873, -122.66149

44.64533, -63.57239

43.17126, -79.24267

49.1693374, 16.5792118

50.20923, 15.83277

49.59552, 17.25175

49.83465, 18.28204

50.08804, 14.42076

50.08804, 14.42076

45.77966, 3.08628

47.21725, -1.55336

48.85341, 2.3488

45.7009, 4.82511

49.25, 4.03333

48.58392, 7.74553

47.49801, 19.03991

47.68333, 17.63512

47.95539, 21.71671

44.83804, 11.62057

43.77925, 11.24626

45.46427, 9.18951

45.44694, 8.62118

38.13205, 13.33561

43.1122, 12.38878

41.89193, 12.51133

41.89193, 12.51133

52.03238, 23.11652

54.51889, 18.53188

41.38879, 2.15899

37.89155, -4.77275

40.4165, -3.70256

43.46472, -3.80444

42.88052, -8.54569

33.80307, -118.07256

25.93315, -80.16255

30.2277, -85.02492

43.6135, -116.20345

44.97997, -93.26384

40.78788, -74.38821

45.52345, -122.67621

31.75872, -106.48693

29.76328, -95.36327

30.15799, -95.48938

38.75095, -77.47527

46.253, 20.14824

41.11148, 16.8554

45.46427, 9.18951

45.40797, 11.88586

49.69501, 22.01926

50.87033, 20.62752

50.06143, 19.93658

51.75, 19.46667

51.25, 22.56667

40.4165, -3.70256

35.38488, -77.99277

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