Status:
TERMINATED
VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Lymphocytic Leukemia (CLL)
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief 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 dev...
Eligibility Criteria
Inclusion
- 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
- Known history of HIV
- Active hepatitis B or C infection
- Receipt of attenuated vaccine within 2 weeks prior to starting study treatment.
Key Trial Info
Start Date :
April 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2023
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03400176
Start Date
April 9 2018
End Date
September 29 2023
Last Update
May 16 2025
Active Locations (5)
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1
University of California San Diego - Moores Cancer Center
La Jolla, California, United States, 92093-0658
2
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
3
Ohio ST Compr Cancer Ctr James Hosp
Columbus, Ohio, United States, 43210
4
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203