Clinical Trials /

Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL

NCT03379051

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

Related Conditions:
  • Chronic Lymphocytic Leukemia
  • Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
VenetoclaxVenclextaUblituximab + Umbralisib + Venetoclax
UmbralisibTGR-1202Ublituximab + Umbralisib + Lenalidomide
UblituximabTG-1101Ublituximab + Umbralisib + Lenalidomide
LenalidomideRevlimidUblituximab + 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

NameTypeDescriptionInterventions
Ublituximab + Umbralisib + VenetoclaxExperimentalUblituximab 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 + LenalidomideExperimentalUblituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Venetoclax 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

January 8, 2021