Trial · NCT04163718
TGR-1202 (Umbralisib) in Treatment Naïve Patients With Chronic Lymphocytic Leukemia (CLL)
NCT04163718, Phase 2, Terminated, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2023-03-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TGR-1202 (Umbralisib) in Treatment Naïve Patients With Chronic Lymphocytic Leukemia (CLL). Trials, record NCT04163718. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04163718
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TGR-1202 (Umbralisib) in Treatment Naïve Patients With Chronic Lymphocytic Leukemia (CLL)
- NCT number
- NCT04163718
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Umbralisib
- First posted
- 2019-11-15
- Last updated
- 2026-01-06
- Results first posted
- 2023-03-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (Complete Response and Partial Response) | Up to 24 months | Overall Response Rate (ORR) of Umbralisib Treatment will be determined according to the criteria of the International Workshop on Chronic Lymphocytic Leukemia. ORR is defined as the percent of participants who achieve Complete Response (CR) or Partial Response (PR). Due to early study termination, result data is provided as best response at End of Treatment/Study Termination. |
| Secondary | Progression Free Survival (PFS) | Up to 24 months | Progression Free Survival (PFS) is defined as the interval from registration to the earlier of the first documentation of definitive disease progression or death from any cause. |
| Secondary | Number of Participants With Serious Adverse Events | Up to 15 months | Number of participants with adverse events after receiving one dose of Umbralisib.. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (Complete Response and Partial Response) | Up to 24 months | Evaluable participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) | Up to 24 months | PFS cannot be calculated. Drug was withdrawn by FDA, therefore all participants off treatment too early to determine survival. | participants | NUMBER |
| SECONDARY | Number of Participants With Serious Adverse Events | Up to 15 months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (Complete Response and Partial Response) | Treatment With Umbralisib | Stable Disease | 1 | Participants | |
| Overall Response Rate (Complete Response and Partial Response) | Treatment With Umbralisib | Partial Response | 8 | Participants | |
| Progression Free Survival (PFS) | Treatment With Umbralisib | NA | participants | ||
| Number of Participants With Serious Adverse Events | Treatment With Umbralisib | 10 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment With Umbralisib | 12 | |
| Overall Study | COMPLETED | Treatment With Umbralisib | 0 | |
| Overall Study | NOT COMPLETED | Treatment With Umbralisib | 12 |
Source ClinicalTrials.gov
Adverse events116
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Treatment With Umbralisib | 9 | 12 | 10 |
| other | Diarrhea | Gastrointestinal disorders | Treatment With Umbralisib | 7 | 12 | 13 |
| other | Bloating | Gastrointestinal disorders | Treatment With Umbralisib | 2 | 12 | 2 |
| other | Gastrointestinal disorders - Other | Gastrointestinal disorders | Treatment With Umbralisib | 2 | 12 | 2 |
| other | Vomiting | Gastrointestinal disorders | Treatment With Umbralisib | 2 | 12 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment With Umbralisib | 1 | 12 | 1 |
| other | Belching | Gastrointestinal disorders | Treatment With Umbralisib | 1 | 12 | 1 |
| other | Dry mouth | Gastrointestinal disorders | Treatment With Umbralisib | 1 | 12 | 1 |
| other | Dysphagia | Gastrointestinal disorders | Treatment With Umbralisib | 1 | 12 | 1 |
| other | Esophageal perforation | Gastrointestinal disorders | Treatment With Umbralisib | 1 | 12 | 1 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment With Umbralisib | 2 | 12 |
| Total, other adverse events | Treatment With Umbralisib | 12 | 12 |
| Total, serious adverse events | Treatment With Umbralisib | 10 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34398557 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04163718
GET https://conductscience.org/api/trials/v1/NCT04163718/events?page=2