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VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib | Clinical Trials | Clareo Health

TERMINATEDPHASE1

VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib

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

NCT03400176•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

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.

Locations (5)

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

Key Dates

Start Date

April 9, 2018

Primary Completion Date

September 29, 2023

Completion Date

September 29, 2023

Last Updated

May 16, 2025

Enrollment

ACTUAL participants

Conditions

Chronic Lymphocytic Leukemia (CLL)

Interventions

VAY736

DRUG

ibrutinib

DRUG

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

NCT06043011

Chronic Lymphocytic Leukemia (CLL)Diffuse Large B-cell Lymphoma (DLBCL)+4 more

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RECRUITINGPHASE1

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

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Lymphoma, B-CellLymphoma, Non-Hodgkin (NHL)+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib

Inclusion Criteria

Exclusion Criteria

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

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