Chronic Lymphocytic Leukemia Clinical Trial

A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation

Summary

This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a cumulative illness rating scale [CIRS]/score of ≤6 and a normal creatinine clearance of ≥70 mL/min) with previously untreated leukemia-cll/" >CLL without DEL(17P) or TP53 mutation requiring treatment. Eligible participants will be randomly assigned in a 1:1 ratio to receive either VEN + G (Arm A) or FCR/BR (Arm B).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Ability to comply with the study protocol, in the investigator's judgment
Aged 18 years or older
Have previously untreated documented Chronic Lymphocytic Leukemia (CLL) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
CLL requiring treatment according to the iwCLL criteria
Cumulative Illness Rating Scale (CIRS) score ≤ 6 and creatinine clearance (CrCl) ≥ 70 mL/min

Hematology values within the following limits, unless cytopenia is caused by the underlying disease (i.e., no evidence of additional bone marrow (BM) dysfunction; e.g., myelodysplastic syndrome, hypoplastic BM):

Absolute neutrophil count ≥ 1.0 x 109/L, unless there is BM involvement
Platelet count ≥ 75 x 109/L and more than 7 days since last transfusion, or ≥ 30 x 109/L if there is BM involvement
Adequate liver function as indicated by a total bilirubin, aspartate aminotransferase, and Alanine transaminase ≤ 2 times the institutional upper limit of normal (ULN) value, unless directly attributable to the participant's CLL
Life expectancy >6 months
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm

Exclusion Criteria:

Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL)
Participants with Small Lymphocyclic Lymphoma (SLL) only
Known central nervous system involvement
Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
Detected del(17p) or TP53 mutation (valid test within 6-months from screening is required for randomisation)
An individual organ/system impairment score of 4 as assessed by the Cumulative Illness Rating Scale (CIRS) definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system
Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
History of prior malignancy
Participants with infections requiring IV treatment (Grade 3 or 4) within the last 8 weeks prior to enrollment
Evidence of other clinically significant uncontrolled conditions including but not limited to active or uncontrolled systemic infection (e.g., viral, bacterial, or fungal)
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
Hypersensitivity to fludarabine, bendamustine, cyclophosphamide, rituximab, obinutuzumab, or venetoclax or to any of the excipients (e.g., trehalose)
Pregnant women and nursing mothers
Vaccination with a live vaccine ≤ 28 days prior to randomization
Prisoners or participants who are institutionalized by regulatory or court order or persons who are in dependence to the Sponsor or an investigator
History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen [HBsAg] serology)
Positive test result for hepatitis C (hepatitis C virus [HCV] antibody serology testing)
Participants with known infection with HIV or Human T-Cell Leukemia Virus 1 (HTLV-1)
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study

Received any of the following agents within 28 days prior to the first dose of study treatment:

Immunotherapy
Radiotherapy
Hormone therapy
Any therapies intended for the treatment of lymphoma/leukemia whether approved or experimental

Participants who have received the following agents:

Strong and moderate CYP3A inhibitors/inducers within 7 days prior to the initiation of study treatment
Steroid therapy for anti-neoplastic intent with the exception of inhaled steroids for asthma, topical steroids, or replacement/stress corticosteroids within 7 days prior to the first dose of study drug administration
Consumed grapefruit, grapefruit products, Seville oranges(including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study drug and throughout venetoclax administration
Inability to swallow a large number of tablets.

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

165

Study ID:

NCT04285567

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 56 Locations for this study

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Medical Center of Aurora; Rocky Mountain Cancer Centers
Aurora Colorado, 80012, United States
Center For Cancer and Blood Disorders
Bethesda Maryland, 20817, United States
Maryland Oncology Hematology, P.A.
Columbia Maryland, 21044, United States
St. Vincent Frontier Cancer Center
Billings Montana, 59101, United States
Regional Cancer Care Associates
Hackensack New Jersey, 07601, United States
New York Oncology Hematology, P.C.
Albany New York, 12206, United States
Oncology Assoc of Oregon, PC
Eugene Oregon, 97401, United States
VA Portland Healthcare System
Portland Oregon, 97239, United States
Consultants in Medical Oncology and Hematology, P.C.
Horsham Pennsylvania, 19044, United States
University of Tennessee Medical Center
Knoxville Tennessee, 37920, United States
Texas Oncology West
Amarillo Texas, 79106, United States
Southwest Regional Cancer Center
Austin Texas, 78705, United States
Texas Oncology-Denton South
Denton Texas, 76201, United States
South Texas Cancer Center - McAllen
McAllen Texas, 78503, United States
Texas Oncology, P.A. - Tyler; Tyler Cancer Center
Tyler Texas, 75702, United States
Community Cancer Trials of Utah
Ogden Utah, 84405, United States
Oncology & Hematolgy Associates of SW Va Inc. - Roanoke
Roanoke Virginia, 24014, United States
Canberra Hospital; Haematology Department
Canberra Australian Capital Territory, 2605, Australia
Liverpool Hospital; Haematology
Liverpool New South Wales, 2170, Australia
Port Macquarie Base Hospital
Port Macquarie New South Wales, 2444, Australia
Royal North Shore Hospital; Haematology Department
St. Leonards New South Wales, 2065, Australia
Royal Adelaide Hospital; Haematology Clinical Trials
Adelaide South Australia, 5000, Australia
Royal Hobart Hospital
Hobart Tasmania, 7000, Australia
The Northern Hospital
Epping Victoria, VIC 3, Australia
Peter MacCallum Cancer Centre; Department of Haematology
Melbourne Victoria, 3002, Australia
Monash Medical Centre; Haematology
Melbourne Victoria, 3168, Australia
CHU de Caen, Institut d'Hématologie de Basse-Normandie
Caen , 14033, France
Hopital Henri Mondor; Hematologie Clinique
Creteil , 94010, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans Cedex 02 , 72015, France
CHRU Lille - Hôpital Claude Huriez; Service des Maladies du Sang
Lille , 59037, France
Hopital Saint Jean : Pole Santé du Rousillon; Unité de Recherche clinique
Perpignan , 66046, France
Hopital De Haut Leveque; Hematologie Clinique
Pessac , 33604, France
Ch Lyon Sud; Hemato Secteur Jules Courmont
Pierre Benite , 69495, France
Hopital De La Miletrie; Hematologie Et Oncologie Medicale
Poitiers , 86021, France
Hopital Robert Debre; Hematologie Clinique
Reims , 51092, France
CHI de Toulon - Hôpital Sainte Musse
Toulon , 83056, France
Hopital Bretonneau; Hematologie Therapie Cellulaire
TOURS Cedex , 37044, France
Azienda Ospedaliero-Universitaria Policlinico di Modena Ematologia
Modena Emilia-Romagna, 41123, Italy
Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol
Roma Lazio, 00161, Italy
Uni Cattolica; Divisione Di Ematologia
Roma Lazio, 00168, Italy
A.O. Universitaria S. Martino Di Genova; Ematologia 1
Genova Liguria, 16132, Italy
Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
Milano Lombardia, 20122, Italy
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia
Milano Lombardia, 20162, Italy
SCDU Ematologia
Novara Piemonte, 28100, Italy
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari Puglia, 70124, Italy
Asl Le-Ospedale "Vito Fazzi";U.O. Ematologia
Lecce Puglia, 73100, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
Sant'Andrea Delle Fratte (PG) Umbria, 06132, Italy
Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
Badalona Barcelona, 08915, Spain
Hospital de Navarra, Servicio de Hematología
Pamplona Navarra, 31008, Spain
Hospital Universitario de Canarias;servicio de Hematologia
La Laguna Tenerife, 38320, Spain
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
Barcelona , 08035, Spain
Hospital Universitario la Paz; Servicio de Hematologia
Madrid , 28046, Spain
Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología
Murcia , 30008, Spain
Hospital Clinico Universitario de Salamanca;Servicio de Hematologia
Salamanca , 37007, Spain
Hospital Universitario Virgen del Rocio; Servicio de Hematologia
Sevilla , 41013, Spain
Hospital Universitario de Toledo
Toledo , 45007, Spain

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

165

Study ID:

NCT04285567

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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