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