Description:
Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib
in Subjects with Relapsed or Refractory CLL/SLL and NHL
Title
- Brief Title: Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL
- Official Title: Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL
Clinical Trial IDs
- ORG STUDY ID:
U2-VEN-109
- NCT ID:
NCT03379051
Conditions
- Chronic Lymphocytic Leukemia
- Non-Hodgkin Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
Venetoclax | Venclexta | Ublituximab + Umbralisib + Venetoclax |
Umbralisib | TGR-1202 | Ublituximab + Umbralisib + Lenalidomide |
Ublituximab | TG-1101 | Ublituximab + Umbralisib + Lenalidomide |
Lenalidomide | Revlimid | Ublituximab + Umbralisib + Lenalidomide |
Purpose
Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib
in Subjects with Relapsed or Refractory CLL/SLL and NHL
Trial Arms
Name | Type | Description | Interventions |
---|
Ublituximab + Umbralisib + Venetoclax | Experimental | Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose | - Venetoclax
- Umbralisib
- Ublituximab
|
Ublituximab + Umbralisib + Lenalidomide | Experimental | Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days | - Umbralisib
- Ublituximab
- Lenalidomide
|
Eligibility Criteria
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)
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Determine Acceptable Adverse Events That Are Related to Treatment |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall Response and Complete Remission Rate |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | Minimum Residual Disease (MRD) |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | TG Therapeutics, Inc. |
Last Updated
August 23, 2021