Trial Search Results
A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy
The purpose of this study is to examine the use of an investigational drug, ABT-199, in patients previously diagnosed with refractory or relapsed chroniclymphocytic leukemia (CLL).
Stanford is currently not accepting patients for this trial.
Lead Sponsor:
AbbVie
Collaborator: Roche-Genentech
Stanford Investigator(s):
Intervention(s):
- Drug: ABT-199
Phase:
Phase 2
Eligibility
Inclusion Criteria:
- Subject must have a diagnosis of CLL that meets 2008 Modified International Workshop
on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (iwCLL NCI-WG)
criteria
- Subject has relapsed/refractory disease with an indication for treatment
- Subject has refractory disease or developed recurrence after therapy with a BCR PI
- Subject must have an Eastern Cooperative Oncology Group performance score of equal to
or less than 2
- Subject must have adequate bone marrow function at Screening
- Subject must have adequate coagulation profile, renal, and hepatic function, per
laboratory reference range at Screening
Exclusion Criteria:
- Subject has undergone an allogeneic stem cell transplant within the past year
- Subject has developed Richter's transformation confirmed by biopsy
- Subject has active and uncontrolled autoimmune cytopenia
- Subject has malabsorption syndrome or other condition that precludes enteral route of
administration
- Subject is human immunodeficiency virus (HIV) positive or has chronic hepatitis B or
hepatitis C virus requiring treatment
- Subject has known contraindication or allergy to both xanthine oxidase inhibitors and
rasburicase.
Ages Eligible for Study
18 Years - 99 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting