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VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib

Trial Status: Active

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.

Inclusion Criteria

  • 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)

Exclusion Criteria

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

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Vladimir Kustanovich
Phone: 310-206-5756
San Diego
University of California San Diego
Status: ACTIVE

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Novartis Pharmaceuticals Corporation

  • Primary ID CVAY736Y2102
  • Secondary IDs NCI-2018-00563
  • Clinicaltrials.gov ID NCT03400176