Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

This is a multicenter, 2-cohort Phase 2 study assessing both minimal residual disease (MRD)-guided discontinuation and fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with treatment-naïve CLL or SLL.

Official Title

Phase 2 Study of the Combination of Ibrutinib Plus Venetoclax in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Keywords

Leukemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Lymphoma, Leukemia, Lymphoid, Leukemia, Lymphocytic, Chronic, B-Cell, Venetoclax, ibrutinib

Eligibility

You can join if…

Open to people ages 18-70

  • Diagnosis of CLL/SLL that meets 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) diagnostic criteria (Hallek et al), with active disease meeting at least 1 IWCLL criteria for requiring treatment.
  • Measurable nodal disease by computed tomography (CT)
  • Adequate hepatic, and renal function
  • Adequate hematologic function
  • absolute neutrophil count >750/µL
  • platelet count >30,000 /μL
  • hemoglobin >8.0 g/dL

You CAN'T join if...

  • Any prior therapy used for treatment of CLL/SLL
  • Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects at risk for tumor lysis syndrome (TLS)

Locations

  • UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 1142-0008
    Orange California 92868-3201 United States
  • City of Hope /ID# 1142-0047
    Duarte California 91010 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pharmacyclics LLC.
ID
NCT02910583
Phase
Phase 2 research study
Study Type
Interventional
Participants
At least 323 people participating
Last Updated