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VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03400176
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia (CLL) Drug: VAY736 Drug: ibrutinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib Open-label Study of VAY736 and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL) on Ibrutinib Therapy
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : August 4, 2023
Estimated Study Completion Date : August 7, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Ibrutinib

Arm Intervention/treatment
Experimental: Dose Escalation
Increasing doses of VAY736 in combination with a fixed dose of ibrutinib.
Drug: VAY736
Experimental

Drug: ibrutinib
Approved medication
Other Name: Imbruvica

Experimental: Dose expansion
Evaluation of the MTD/RD of the combination of VAY736 and ibrutinib that was identified in dose escalation.
Drug: VAY736
Experimental

Drug: ibrutinib
Approved medication
Other Name: Imbruvica




Primary Outcome Measures :
  1. DLT rate [ Time Frame: 1 year ]
    To determine the incidence of DLTs.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Two years ]
    To determine preliminary antitumor activity of the combination.

  2. Time to progression (TTP) [ Time Frame: Two years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400176


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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United States, California
University of California San Diego - Moores Cancer Center Recruiting
La Jolla, California, United States, 92093-0658
Contact    858-534-5400      
Principal Investigator: Thomas J Kipps         
David Geffen School of Medicine at UCLA David Geffen School of Med Recruiting
Los Angeles, California, United States, 90095
Contact: Nicole Alimi NP       nalimi@mednet.ucla.edu   
Principal Investigator: Sarah Larson         
United States, Ohio
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact    614-293-5655      
Principal Investigator: Kerry Rodgers         
United States, Tennessee
Tennessee Oncology Centennial Medical Center Recruiting
Nashville, Tennessee, United States, 37203
Contact    615-986-7274      
Principal Investigator: Ian W. Flinn         
United States, Utah
University of Utah / Huntsman Cancer Institute Oncology Recruiting
Salt Lake City, Utah, United States, 84103
Contact: Maggie Rittel    801-213-4301    Maggie.rittel@hci.utah.edu   
Principal Investigator: Deborah Stephens         
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03400176    
Other Study ID Numbers: CVAY736Y2102
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Ibrutinib
VAY736
Chronic lymphocytic leukemia
CLL
Bruton's Tyrosine Kinase
BTK mutation
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell