This study is in progress, not accepting new patients

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

a study on Chronic Lymphocytic Leukemia Leukemia

Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at UCLA UCSD
Dates
study started
estimated completion

Description

Summary

This is an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy and safety of ABT-199 in approximately 120 subjects with relapsed or refractory CLL after B-cell receptor signaling pathway inhibitors (BCR PI) treatment.

Official Title

A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy

Keywords

Chronic Lymphocytic Leukemia Oncology Cancer of the blood and bone marrow Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Venetoclax ABT-199 ABT-199 after ibrutinib therapy ABT-199 after idelalisib therapy

Eligibility

You can join if…

Open to people ages 18-99

  • 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

You CAN'T join if...

  • 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.

Locations

  • Ucsd /Id# 128535
    La Jolla California 92093 United States
  • University of California, Los Angeles /ID# 127262
    Los Angeles California 90095 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT02141282
Phase
Phase 2
Study Type
Interventional
Last Updated