VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib

Part of paid clinical trials in La Jolla, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03400176
Phase
PHASE1
Status
Terminated

Conditions

  • Chronic Lymphocytic Leukemia (CLL)

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • VAY736 — DRUG
    Experimental
  • ibrutinib — DRUG
    Approved medication

Study Details

Patients enrolled to the study had chronic lymphocytic leukemia (CLL) and received ibrutinib. Patients had either received ibrutinib for one year without having had a complete response or patients developed a resistance mutation to ibrutinib. This study had two parts, a dose escalation part and a dose expansion part.

Key Dates

Start date
Apr 9, 2018
Status verified
May 2025
Primary completion
Sep 29, 2023
Completion
Sep 29, 2023

Study Design

Enrollment
39 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Increasing doses of VAY736 in combination with a fixed dose of ibrutinib.
  • Experimental: Dose expansion
    Evaluation of the MTD/RD of the combination of VAY736 and ibrutinib that was identified in dose escalation.

Primary Outcome Measure

Number of Participants With Dose-Limiting Toxicities (DLTs) in Cycle 1 (Escalation Only) [ Time Frame: 28 days ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of California San Diego - Moores Cancer CenterLa JollaCalifornia92093-0658-
David Geffen School of Medicine at UCLALos AngelesCalifornia90095-
Ohio ST Compr Cancer Ctr James HospColumbusOhio43210-
SCRI Oncology PartnersNashvilleTennessee37203-
Uni of Utah Huntsman Cancer InstSalt Lake CityUtah84103-

Find similar trials in La Jolla, CA

By research site
University of California San Diego - Moores Cancer Center· La Jolla, CADavid Geffen School of Medicine at UCLA· Los Angeles, CAOhio ST Compr Cancer Ctr James Hosp· Columbus, OHSCRI Oncology Partners· Nashville, TNUni of Utah Huntsman Cancer Inst· Salt Lake City, UT

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