Chronic Lymphocytic Leukemia Clinical Trial

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

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 leukemia-cll/" >CLL after B-cell receptor signaling pathway inhibitors (BCR PI) treatment.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participant must have a diagnosis of chronic lymphocytic leukemia (CLL) that meets 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (IWCLL NCI-WG) criteria
Participant has relapsed/refractory disease with an indication for treatment
Participant has refractory disease or developed recurrence after therapy with a B-cell receptor pathway inhibitor (BCR PI)
Participant must have an Eastern Cooperative Oncology Group performance score of ≤ 2
Participant must have adequate bone marrow function at Screening
Participant must have adequate coagulation profile, renal, and hepatic function, per laboratory reference range at Screening

Exclusion Criteria:

Participant has undergone an allogeneic stem cell transplant within the past year
Participant has developed Richter's transformation confirmed by biopsy
Participant has active and uncontrolled autoimmune cytopenia
Participant has malabsorption syndrome or other condition that precludes enteral route of administration
Participant is human immunodeficiency virus (HIV) positive or has chronic hepatitis B or hepatitis C virus requiring treatment
Participant has known contraindication or allergy to both xanthine oxidase inhibitors and rasburicase

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

127

Study ID:

NCT02141282

Recruitment Status:

Completed

Sponsor:

AbbVie

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 13 Locations for this study

See Locations Near You

Moores Cancer Center at UC San Diego /ID# 128535
La Jolla California, 92093, United States
University of California, Los Angeles /ID# 127262
Los Angeles California, 90095, United States
Stanford University School of Med /ID# 126495
Stanford California, 94305, United States
Georgetown University Hospital /ID# 127261
Washington District of Columbia, 20007, United States
Emory Midtown Infectious Disease Clinic /ID# 131249
Atlanta Georgia, 30322, United States
Northwestern University Feinberg School of Medicine /ID# 126497
Chicago Illinois, 60611, United States
Beth Israel Deaconess Medical Center /ID# 134509
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute /ID# 126496
Boston Massachusetts, 02215, United States
Columbia Univ Medical Center /ID# 128536
New York New York, 10032, United States
New York Presbyterian Hospital Weill Cornell Medical Center /ID# 129648
New York New York, 10032, United States
Univ Rochester Med Ctr /ID# 130011
Rochester New York, 14642, United States
The Ohio State University /ID# 127263
Columbus Ohio, 43210, United States
University of Pennsylvania /ID# 126860
Philadelphia Pennsylvania, 19104, United States
University of Texas MD Anderson Cancer Center /ID# 126498
Houston Texas, 77030, United States
University of Utah /ID# 130813
Salt Lake City Utah, 84112, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

127

Study ID:

NCT02141282

Recruitment Status:

Completed

Sponsor:


AbbVie

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.