Summary

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

Description

Summary

This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics of venetoclax (GDC-0199, ABT-199) administered in combination with bendamustine and rituximab (BR) (MabThera/Rituxan) or bendamustine and obinutuzumab (BG) to participants with relapsed/refractory or previously untreated CLL. The study will explore two schedules for drug administration, Schedule A (venetoclax introduced before other agents) and Schedule B (introduced after other agents). In addition, the study will explore two venetoclax combination regimens: venetoclax+BR and venetoclax + BG (the latter is optional). The study is comprised of two stages for each participant population: a dose-finding stage and a safety-expansion stage. The dose-finding stage will explore multiple doses of venetoclax to be used in combination with fixed doses of BR or BG.

Official Title

A Phase IB, Open-Label Study Evaluating the Safety and Pharmacokinetics of Venetoclax (GDC-0199, ABT-199) in Combination With Bendamustine+Rituximab (BR) or Bendamustine+Obinutuzumab (BG) in Patients With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Obinutuzumab Venetoclax Rituximab Bendamustine Hydrochloride Bendamustine Dose-Finding: Schedule A (Optional): CLL Dose-Finding: Schedule A: Previously Untreated CLL Dose-Finding: Schedule A: Relapsed/Refractory CLL Dose-Finding: Schedule B (Optional): CLL Dose-Finding: Schedule B: Previously Untreated CLL Dose-Finding: Schedule B: Relapsed/Refractory CLL Safety Expansion (Optional): Previously Untreated CLL Safety Expansion: Previously Untreated CLL Safety Expansion: Relapsed/Refractory CLL

Eligibility

You can join if…

Open to people ages 18 years and up

  • Diagnosis of relapsing/refractory or previously untreated CLL
  • Eastern Cooperative Oncology Group (ECOG) performance score of less than equal to(</=) 1
  • Adequate bone marrow function
  • Adequate coagulation, renal and hepatic function
  • Hematological values within the limits independent of growth factor support or transfusion unless cytopenia is caused by the underlying disease, i.e., no evidence of additional bone marrow dysfunction (e.g., myelodysplastic syndrome, hypoplastic bone marrow)

You CAN'T join if...

  • Participants received an allogeneic stem cell transplant
  • Known human immunodeficiency virus (HIV) positivity
  • Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
  • Positive test results for chronic hepatitis B infection and hepatitis C virus (HCV)
  • Received any anti-cancer therapy including chemotherapy or radiotherapy, steroid therapy for anti-neoplastic intent, and investigational therapy, including targeted small molecule agents within 28 days prior to the first dose of study drug or has not recovered to less than Grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy
  • Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic,immunologic, cardiovascular, or hepatic disease

Locations

  • University of California San Diego Medical Center
    La Jolla California 92093-5354 United States
  • North Star Lodge
    Yakima Washington 98902 United States
  • Yakima Valley Memorial Hospital/North Star Lodge
    Yakima Washington 98902 United States
  • Evergreen Hematology and Oncology
    Spokane Washington 99218 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genentech, Inc.
ID
NCT01671904
Phase
Phase 1
Study Type
Interventional
Last Updated
August 8, 2018