Chronic Lymphocytic Leukemia Clinical Trial

A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Summary

The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC).

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Full Description

The hypothesis is treatment with combination of I+VEN will result in longer PFS compared with G-Clb in participants with previously untreated leukemia-cll/" >chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) who meet International Workshop on CLL (iwCLL) treatment criteria. The study includes screening (30 days), treatment (from randomization until treatment discontinuation) and follow-up phase (from treatment discontinuation until Subsequent Therapy Phase [if applicable], death, lost to follow up, consent withdrawal, or study end, whichever occurs first). Participants without progression will continue disease evaluations until disease progression or death. Participants from either treatment arm that develop progressive disease may be eligible to receive single-agent ibrutinib until disease progression or unacceptable toxicity (Subsequent Therapy Phase). Participation in this phase of the study is not mandatory and is based on investigator's discretion. Study duration is approximately 6 years. Safety includes review of adverse events and laboratory tests performed over time.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adult participants who are: (a) greater than or equal to (>=) 65 years old or, (b) 18 to 64 years old and have at least 1 of the following:

Cumulative Illness Rating Scale (CIRS) score > 6
Creatinine clearance (CrCl) estimated less than (<) 70 milliliter per minute (mL/min) using Cockcroft-Gault equation
Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that meets International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
Measurable nodal disease (by computed tomography [CT]), defined as at least one lymph node > 1.5 centimeter (cm) in longest diameter
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade less than or equal to (<=) 2
Active CLL/SLL requiring treatment per the iwCLL criteria

Exclusion Criteria:

Prior anti-leukemic therapy for CLL or SLL
Presence of deletion of the short arm of chromosome 17 (del17p) or known TP53 mutation detected at a threshold of >10 percent (%) variable allele frequency (VAF)
Major surgery within 4 weeks of first dose of study treatment
Known bleeding disorders (example, von Willebrand's disease or hemophilia)
Central nervous system (CNS) involvement or suspected Richter's syndrome

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

211

Study ID:

NCT03462719

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 85 Locations for this study

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Norton Cancer Institute
Louisville Kentucky, 40207, United States
John Theurer Cancer Center
Hackensack New Jersey, 07601, United States
Novant Health
Charlotte North Carolina, 28204, United States
Institut - Jules Bordet
Anderlecht , 1070, Belgium
ZNA Stuivenberg
Antwerpen , 2060, Belgium
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
Virga Jessa Ziekenhuis
Hasselt , 3500, Belgium
UZ Leuven Gasthuisberg
Leuven , 3000, Belgium
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Juravinski Cancer Centre
Hamilton Ontario, L8V 5, Canada
The Ottawa Hospital - General Campus
Ottawa Ontario, K1H 8, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont
Montreal Quebec, H1T 2, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika
Brno , 625 0, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Fakultni nemocnice Ostrava
Ostrava , 708 5, Czechia
Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
Plzen , 323 0, Czechia
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
Praha 2 , 128 0, Czechia
Aalborg University Hospital
Aalborg , 9000, Denmark
Aarhus Universitetshospital
Aarhus , 8200, Denmark
Rigshospitalet
Copenhagen , 2100, Denmark
Odense Universitetshospital
Odense C , 5000, Denmark
Roskilde Sygehus
Roskilde , DK- 4, Denmark
CHU de Clermont-Ferrand
Clermont Ferrand , 63000, France
Hopital Claude Huriez
Lille , 59000, France
CHU Montpellier
Montpellier , 34295, France
Hopital Haut Leveque Service Maladie Du Sang
Pessac , 33604, France
Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré
Reims , 51100, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse Cedex 9 , 31059, France
CHU Bretonneau
Tours Cedex 9 , 37044, France
CHU-Nancy
Vandoeuvre les Nancy , 54511, France
Institut Gustave Roussy
Villejuif , 94805, France
Bnai Zion Medical Center
Haifa , 31048, Israel
Carmel Medical Center
Haifa , 34362, Israel
Hadassah Medical Center
Jerusalem , 91120, Israel
Western Galilee Medical Center
Nahariya , 22100, Israel
Sheba Medical Center
Ramat Gan , 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Flevoziekenhuis
Almere , 1315R, Netherlands
OLVG
Amsterdam , 1091A, Netherlands
Academic Medical Center
Amsterdam , 1105 , Netherlands
Reinier de Graaf Gasthuis
Delft , 2625 , Netherlands
MC Haaglanden
Den Haag , 2512 , Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht , 3318 , Netherlands
Catharinaziekenhuis
Eindhoven , 5623 , Netherlands
Spaarne Gasthuis
Hoofddorp , 2134 , Netherlands
Zuyderland Medical Center
Sittard-Geleen , 6162 , Netherlands
Antonius hospital
Sneek , 8601 , Netherlands
Elisabeth zkh
Tilburg , 5022 , Netherlands
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów , 41-50, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz , 93-51, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin , 20-08, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka,
Slupsk , 76-20, Poland
Instytut Hematologii i Transfuzjologii
Warszawa , 02-77, Poland
S.P. Botkin Moscow City Clinical Hospital
Moscow , 12528, Russian Federation
Nizhniy Novgorod Region Clinical Hospital
Nizhny Novgorod , 60312, Russian Federation
Ryazan Regional Clinical Hospital
Ryazan , 39003, Russian Federation
FSBIFederal Centre of Heart, Blood and Endocrinology named after V.A.Almazov MoH of the RF
Saint Petersburg , 19734, Russian Federation
St.-Petersburg Clinical Research Institute of Hematology and Transfusiology
St. Petersburg , 19302, Russian Federation
Hosp. Univ. Vall D Hebron
Barcelona , 08035, Spain
Hosp. Clinic I Provincial de Barcelona
Barcelona , 08036, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona , 8041, Spain
Hosp. Univ. de La Princesa
Madrid , 28006, Spain
Hosp. Gral. Univ. Gregorio Marañon
Madrid , 28007, Spain
Hosp. Univ. Infanta Leonor
Madrid , 28031, Spain
Hospital Ramon y Cajal
Madrid , 28034, Spain
Hosp. Univ. Fund. Jimenez Diaz
Madrid , 28040, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hospital Clinico Universitario Salamanca
Salamanca , 37007, Spain
Hosp. Virgen Del Rocio
Sevilla , 41013, Spain
Sunderby Sjukhus Medicinkliniken
Luelå , 97180, Sweden
Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm
Stockholm , 171 7, Sweden
Gazi Universitesi Tip FalKultesi
Ankara , 06500, Turkey
Ankara Universitesi Tip Fakültesi Ibn-i Sina Hastanesi
Ankara , 6590, Turkey
Ondokuz Mayis Universitesi Tip Fakultesi
Atakum , 55270, Turkey
V.K.V. Amerikan Hastanesi
Istanbul , 34365, Turkey
Dokuz Eylul Universitesi Tip Fakultesi
Izmir , 35340, Turkey
Birmingham Heartlands Hospital
Birmingham , B9 5S, United Kingdom
Addenbrookes Hospital
Cambridge , CB2 0, United Kingdom
Queen Mary University of London
Charterhouse Square , EC1M , United Kingdom
New Victoria Hospital
Glasgow , G42 9, United Kingdom
St James's Hospital
Leeds , LS9 7, United Kingdom
Derriford Hospital
Plymouth , PL6 8, United Kingdom
Barking Havering and Redbridge University Hospitals NHS Trust
Romford , RM7 0, United Kingdom
Royal Hallamshire Hospital
Sheffield , S10 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

211

Study ID:

NCT03462719

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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