VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib

a study on Chronic Lymphocytic Leukemia Leukemia

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
estimated completion
Principal Investigator
by Thomas J Kipps (ucsd)Sarah Larson (ucla)
Photo of Thomas J Kipps
Thomas J Kipps

Description

Summary

Patients enrolled to the study will have chronic lymphocytic leukemia (CLL) and are actively receiving ibrutinib. Patients will have either been receiving ibrutinib for one year without having had a complete response or patients will have developed a resistance mutation to ibrutinib. This study will have two parts, a dose escalation part and a dose expansion part. In the dose escalation part, the maximum tolerated dose (MTD) of the combination of VAY736 with ibrutinib will be determined. Once determined, the dose expansion part of the study will begin.

Official Title

Phase Ib Open-label Study of VAY736 and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL) on Ibrutinib Therapy

Keywords

Chronic Lymphocytic Leukemia (CLL) Ibrutinib VAY736 Chronic lymphocytic leukemia CLL Bruton's Tyrosine Kinase BTK mutation Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Dose Escalation Dose expansion

Eligibility

You can join if…

Open to people ages 18 years and up

  • Diagnosis of CLL per the WHO classification
  • At least 18 years of age
  • Lack of a complete response after receiving ibrutinib for > 1 year OR presence of known ibrutinib resistance mutation
  • Actively receiving ibrutinib at either 420 mg (patients enrolled to the escalation arm) or at a stable dose for at least 2 months prior to starting study treatment (patients enrolled to the expansion arm)

You CAN'T join if...

  • Known history of HIV
  • Active hepatitis B or C infection
  • Receipt of attenuated vaccine within 2 weeks prior to starting study treatment.

Locations

  • University of California San Diego - Moores Cancer Center accepting new patients
    La Jolla California 92093-0658 United States
  • David Geffen School of Medicine at UCLA David Geffen School of Med accepting new patients
    Los Angeles California 90095 United States

Lead Scientists at UC Cancer

  • Thomas J Kipps (ucsd)
    Thomas Kipps, MD, PhD, is Professor of Medicine, Evelyn and Edwin Tasch Chair in Cancer Research, and Deputy Director of Research Operations at the UC San Diego Moores Cancer Center. He received his Ph.D. in Immunology and M.D. from Harvard University and had his residency and fellowship training in Internal Medicine, Hematology, and Genetics at Stanford University.
  • Sarah Larson (ucla)
    HS Assistant Clinical Professor, Medicine. Authored (or co-authored) 10 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT03400176
Phase
Phase 1
Study Type
Interventional
Last Updated