Extension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials

TG Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Chronic Lymphocytic Leukemia; Non Hodgkin Lymphoma

Treatments: Drug: TGR-1202 + Ublituximab; Drug: TGR-1202

Study type: Interventional

Funder types: Industry

Identifiers

NCT03207256

UTX-TGR-501

Details and patient eligibility

About

This is an open label compassionate use trial of Ublituximab and TGR-1202 in combination or as single agents in patients currently receiving treatment on Ublituximab and/or TGR-1202 trials with B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia.

Enrollment: 51 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must be currently receiving treatment with ublituximab and/or TGR-1202 on a previously approved protocol.
• Subjects must have completed at least 6 cycles of therapy on their current protocol.

Exclusion criteria

• Subject progressed while receiving therapy with ublituximab and/or TGR-1202 while participating in their immediate previous trial.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

TGR-1202

Experimental group

Description:

Oral TGR-1202 Daily

Treatment:

Drug: TGR-1202

TGR-1202 + Ublituximab

Experimental group

Description:

Oral TGR-1202 in combination with Ublituximab intravenous administration

Treatment:

Drug: TGR-1202 + Ublituximab