NCT03207256|TerminatedPhase 2FDA Drug

Study Stopped

Strategic/Business Decision

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.

TG Therapeutics, Inc.ClinicalTrials.gov

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1 other identifier

UTX-TGR-501

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJul 2017

StartedAug 2017

CompletionJun 2022

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Aug 2017

Longer than P75 for phase_2

Geographic Reach

1 country

17 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.9 years study duration

First Submitted

Initial submission to the registry

June 28, 2017

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed

1 month until next milestone

Study Start

First participant enrolled

August 9, 2017

Completed

4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2022

Completed

Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

4.8 years

First QC Date

June 28, 2017

Last Update Submit

July 20, 2022

Conditions

Chronic Lymphocytic Leukemia Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Study Arms (2)

TGR-1202

EXPERIMENTAL

Oral TGR-1202 Daily

Drug: TGR-1202

TGR-1202 + Ublituximab

EXPERIMENTAL

Oral TGR-1202 in combination with Ublituximab intravenous administration

Drug: TGR-1202 + Ublituximab

Interventions

TGR-1202DRUG

Oral Daily TGR-1202

TGR-1202

TGR-1202 + UblituximabDRUG

Oral Daily TGR-1202 + Ublituximab IV Administration

TGR-1202 + Ublituximab

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.