VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib
NCT ID: NCT03400176
Last Updated: 2025-05-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
39 participants
INTERVENTIONAL
2018-04-09
2023-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Escalation
Increasing doses of VAY736 in combination with a fixed dose of ibrutinib.
VAY736
Experimental
ibrutinib
Approved medication
Dose expansion
Evaluation of the MTD/RD of the combination of VAY736 and ibrutinib that was identified in dose escalation.
VAY736
Experimental
ibrutinib
Approved medication
Interventions
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VAY736
Experimental
ibrutinib
Approved medication
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Active hepatitis B or C infection
* Receipt of attenuated vaccine within 2 weeks prior to starting study treatment.
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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University of California San Diego - Moores Cancer Center
La Jolla, California, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Ohio ST Compr Cancer Ctr James Hosp
Columbus, Ohio, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Uni of Utah Huntsman Cancer Inst
Salt Lake City, Utah, United States
Countries
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References
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Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on www.novctrd.com
Other Identifiers
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CVAY736Y2102
Identifier Type: -
Identifier Source: org_study_id
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