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

An Open Label Extension Trial of Ublituximab and/or Umbralisib (TGR-1202) in Combination With Other Novel Agents or as Single Agents in Subjects Currently Receiving Treatment on a TG Therapeutics Study.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03207256

Enrollment

Registered

2017-07-02

Start date

2017-08-09

Completion date

2022-06-24

Last updated

2022-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma

Brief summary

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.

Interventions

DRUGTGR-1202

Oral Daily TGR-1202

DRUGTGR-1202 + Ublituximab

Oral Daily TGR-1202 + Ublituximab IV Administration

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
Adverse Events of TGR-1202 and/or TGR-1202 + ublituximab treatment, including delayed toxicities	Evaluated at each planned visit through study completion, an average of 2 years	Toxicity according to the investigator (Adverse events with NCI-CTC 4.0)

Secondary

Measure	Time frame	Description
Progression-free survival of TGR-1202 and/or TGR-1202 + ublituximab treatment	Evaluated at each planned visit through study completion, an average of 2 years	Date of progression reported for each patient

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026