Back to resultsVAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib
Primary Purpose
Chronic Lymphocytic Leukemia (CLL)
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VAY736
ibrutinib
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia (CLL) focused on measuring Ibrutinib, VAY736, Chronic lymphocytic leukemia, CLL, Bruton's Tyrosine Kinase, BTK mutation
Eligibility 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.
Sites / Locations
- University of California San Diego - Moores Cancer Center
- David Geffen School of Medicine at UCLA David Geffen School of Med
- Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State University
- Tennessee Oncology Centennial Medical Center
- University of Utah / Huntsman Cancer Institute Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dose Escalation
Dose expansion
Arm Description
Increasing doses of VAY736 in combination with a fixed dose of ibrutinib.
Evaluation of the MTD/RD of the combination of VAY736 and ibrutinib that was identified in dose escalation.
Outcomes
Primary Outcome Measures
DLT rate
To determine the incidence of DLTs.
Secondary Outcome Measures
Overall Response Rate (ORR)
To determine preliminary antitumor activity of the combination.
Time to progression (TTP)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03400176
Brief Title
VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib
Official Title
Phase Ib Open-label Study of VAY736 and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL) on Ibrutinib Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
December 6, 2024 (Anticipated)
Study Completion Date
December 6, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia (CLL)
Keywords
Ibrutinib, VAY736, Chronic lymphocytic leukemia, CLL, Bruton's Tyrosine Kinase, BTK mutation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose Escalation
Arm Type
Experimental
Arm Description
Increasing doses of VAY736 in combination with a fixed dose of ibrutinib.
Arm Title
Dose expansion
Arm Type
Experimental
Arm Description
Evaluation of the MTD/RD of the combination of VAY736 and ibrutinib that was identified in dose escalation.
Intervention Type
Drug
Intervention Name(s)
VAY736
Intervention Description
Experimental
Intervention Type
Drug
Intervention Name(s)
ibrutinib
Other Intervention Name(s)
Imbruvica
Intervention Description
Approved medication
Primary Outcome Measure Information:
Title
DLT rate
Description
To determine the incidence of DLTs.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
To determine preliminary antitumor activity of the combination.
Time Frame
Two years
Title
Time to progression (TTP)
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of California San Diego - Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
David Geffen School of Medicine at UCLA David Geffen School of Med
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Tennessee Oncology Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
University of Utah / Huntsman Cancer Institute Oncology
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34398557
Citation
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.
Results Reference
derived
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VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib
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