Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The anticipated time on study treatment will be approximately one year and the follow-up period will be up to 5 years.

Official Title

A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax (GDC-0199/ABT-199) Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions

Keywords

Lymphocytic Leukemia, Chronic Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Obinutuzumab Venetoclax Chlorambucil Obinutuzumab + Chlorambucil Obinutuzumab + Venetoclax

Eligibility

You can join if…

Open to people ages 18 years and up

  • Documented previously untreated CLL according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
  • CLL requiring treatment according to IWCLL criteria
  • Total Cumulative Illness Rating Scale (CIRS score) greater than (>) 6
  • Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening as per protocol, unless cytopenia is due to marrow involvement of CLL
  • Adequate liver function
  • Life expectancy > 6 months
  • Agreement to use highly effective contraceptive methods per protocol

You CAN'T join if...

  • Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter's transformation or pro-lymphocytic leukemia)
  • Known central nervous system involvement
  • Participants with a history of confirmed progressive multifocal leukoencephalopathy(PML)
  • An individual organ/ system impairment score of 4 as assessed by the 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
  • Inadequate renal function
  • History of prior malignancy, except for conditions as listed in the protocol if patients have recovered from the acute side effects incurred as a result of previous therapy
  • Use of investigational agents or concurrent anti-cancer treatment within the last 4 weeks of registration
  • Participants with active bacterial, viral, or fungal infection requiring systemic treatment within the last two months prior to registration
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
  • Hypersensitivity to chlorambucil, obinutuzumab, or venetoclax or to any of the excipients
  • Pregnant women and nursing mothers
  • Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen [HBsAg] serology) or positive test result for hepatitis C (hepatitis C virus [HCV] antibody serology testing)
  • Participants with known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus-1 (HTLV-1)
  • Requires the use of warfarin, marcumar, or phenprocoumon
  • Received agents known to be strong and moderate Cytochrome P450 3A inhibitors or inducers within 7 days prior to the first dose of study drug

Locations

  • UC San Diego Health System
    La Jolla California 92093 United States
  • San Diego Pacific Hematology Assocates
    Encinitas California 92024-1375 United States
  • cCare
    Encinitas California 92024 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02242942
Phase
Phase 3
Study Type
Interventional
Last Updated