Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma
Conditions
Brief summary
Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib in Subjects with Relapsed or Refractory CLL/SLL and NHL
Interventions
DRUGVenetoclax
BCL-2 Inhibitor
DRUGUmbralisib
PI3K-Delta Inhibitor
BIOLOGICALUblituximab
Glycoengineered Anti-CD20 mAb
DRUGLenalidomide
Thalidomide Analog, immunomodulatory agent with antiangiogenic and antineoplastic properties
Sponsors
James P. Wilmot Cancer Center
TG Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia, or Non-Hodgkin's Lymphoma * Refractory to or relapsed after at least 1 prior treatment regimen * Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
Exclusion criteria
* Any major surgery, chemotherapy or immunotherapy within the last 21 days * Known hepatitis B virus, hepatitis C virus or HIV infection * Known histological transformation from CLL to an aggressive lymphoma (Richter's)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine Acceptable Adverse Events That Are Related to Treatment | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response and Complete Remission Rate | 12 months |
| Minimum Residual Disease (MRD) | 12 months |
Countries
United States
Outcome results
None listed