NCT02742090|TerminatedPhase 2Results

Study Stopped

(Strategic/Business Decision)

Evaluate the Efficacy and Safety of TGR-1202 in Participants With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy

A Phase 2 Study to Assess the Safety and Efficacy of TGR-1202 (Umbralisib) in Patients With Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K-Delta Inhibitor Therapy

TG Therapeutics, Inc.ClinicalTrials.gov

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1 other identifier

TGR-1202-201-CLL

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredApr 2016

StartedApr 2016

CompletionJun 2021

Brief Summary

The main objective of this study is to determine the progression free survival of umbralisib in participants who were intolerant to prior BTK (Bruton Tyrosine Kinase) inhibitors (ibrutinib, ACP-196, other) or prior PI3K-delta inhibitors (idelalisib, duvelisib, other).

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 Apr 2016

Longer than P75 for phase_2

Geographic Reach

1 country

15 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

5.1 years study duration

First Submitted

Initial submission to the registry

April 11, 2016

Completed

7 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed

3 days until next milestone

Study Start

First participant enrolled

April 21, 2016

Completed

5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed

3.1 years until next milestone

Results Posted

Study results publicly available

July 3, 2024

Completed

Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

5.1 years

First QC Date

April 11, 2016

Results QC Date

June 7, 2024

Last Update Submit

June 7, 2024

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLL

Outcome Measures

Primary Outcomes (1)

Progression-free Survival
PFS was defined as the interval from Day 1 to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. Participants who had no event (progression or death) were censored at the day of their last adequate disease assessment.
From Day 1 to the earlier of the first documentation of definitive disease progression or death (Up to 61.7 months)

Secondary Outcomes (4)

Overall Response Rate (ORR)
Up to 61.7 months
Time to Treatment Failure (TTF)
From Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death (up to approximately 61.7 months)
Duration of Response (DOR)
From first documentation of CR or PR till disease progression/death (up to approximately 61.7 months)
Number of Participants With Treatment-Emergent Adverse Events (TEAE's) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)
From first dose of study treatment up to end of study (up to 61.7 months)

Study Arms (1)

Umbralisib

EXPERIMENTAL

Participants received 800 milligrams (mg) of umbralisib, orally, once daily until disease progression, unacceptable toxicity or the end of the study for 60.7 months.

Drug: Umbralisib

Interventions

UmbralisibDRUG

Umbralisib was administered as a tablet(s), orally once daily.

Also known as: TGR-1202

Umbralisib

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
Discontinuation on prior BTK inhibitor or PI3K delta inhibitor due to adverse events within prior 9 months
Presence of measurable disease

You may not qualify if:

Progression on prior BTK or PI3K delta inhibitor
Prior treatment with TGR-1202
Richter's transformation or CLL transformation to aggressive lymphoma

Contact the study team to confirm eligibility.