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

TG Therapeutics

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma

Treatments: Drug: Umbralisib; Biological: Ublituximab; Drug: Lenalidomide; Drug: Venetoclax

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03379051

U2-VEN-109

Details and patient eligibility

About

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

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Ublituximab + Umbralisib + Venetoclax

Experimental group

Description:

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

Treatment:

Drug: Venetoclax

Biological: Ublituximab

Drug: Umbralisib

Ublituximab + Umbralisib + Lenalidomide

Experimental group

Description:

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

Treatment:

Drug: Lenalidomide

Biological: Ublituximab

Drug: Umbralisib