Trial · NCT04149821
Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy
NCT04149821, Phase 2, Terminated, Weill Medical College of Cornell University; results first posted 2023-06-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy. Trials, record NCT04149821. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04149821
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy
- NCT number
- NCT04149821
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Weill Medical College of Cornell University
- Conditions
- Chronic Lymphocytic Leukemia, CLL Progression, CLL/SLL
- Interventions
- Umbralisib, Ublituximab
- First posted
- 2019-11-04
- Last updated
- 2023-06-15
- Results first posted
- 2023-06-15
- Limitations and caveats
- The study did not reach the target number of participants needed to achieve target power and statistically reliable results
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Umbralisib in Combination With Ublituximab (U2) as Measured by Overall Response Rate (ORR) in Patients With CLL Who Have Progressed on a BTKi or BCL-2 Inhibitor | 11 months | Number of subjects who achieve a partial or complete response |
| Secondary | Safety of Umbralisib in Combination With Ublituximab (U2) as Measured by the Percentage of Subjects Who Experience 1 or More Adverse Events | 1 year and 4 months | Rate of subjects who experience 1 or more adverse events |
| Secondary | Complete Remission Rate as Measured by the Number of Subjects Who Achieve Complete Response as Their Best Response | 1 year and 4 months | Number of subjects who achieve complete response on study |
| Secondary | Duration of Response | 1 year and 4 months | Median interval of time between subjects' first objective response to the first sign of disease progression |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of Umbralisib in Combination With Ublituximab (U2) as Measured by Overall Response Rate (ORR) in Patients With CLL Who Have Progressed on a BTKi or BCL-2 Inhibitor | 11 months | 0 subjects were enrolled in Cohort A. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety of Umbralisib in Combination With Ublituximab (U2) as Measured by the Percentage of Subjects Who Experience 1 or More Adverse Events | 1 year and 4 months | 0 subjects were enrolled in Cohort A. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Complete Remission Rate as Measured by the Number of Subjects Who Achieve Complete Response as Their Best Response | 1 year and 4 months | 0 subjects were enrolled in Cohort A. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response | 1 year and 4 months | 0 subjects were enrolled in Cohort A. | years | 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 |
|---|---|---|---|---|---|
| Efficacy of Umbralisib in Combination With Ublituximab (U2) as Measured by Overall Response Rate (ORR) in Patients With CLL Who Have Progressed on a BTKi or BCL-2 Inhibitor | Cohort B Post BCL-2 Therapy | 0 | Participants | ||
| Safety of Umbralisib in Combination With Ublituximab (U2) as Measured by the Percentage of Subjects Who Experience 1 or More Adverse Events | Cohort B Post BCL-2 Therapy | 1 | Participants | ||
| Complete Remission Rate as Measured by the Number of Subjects Who Achieve Complete Response as Their Best Response | Cohort B Post BCL-2 Therapy | 0 | Participants | ||
| Duration of Response | Cohort B Post BCL-2 Therapy | 0 | years |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A Post BTKi Therapy | 0 | |
| Overall Study | STARTED | Cohort B Post BCL-2 Therapy | 1 | |
| Overall Study | COMPLETED | Cohort A Post BTKi Therapy | 0 | |
| Overall Study | COMPLETED | Cohort B Post BCL-2 Therapy | 1 | |
| Overall Study | NOT COMPLETED | Cohort A Post BTKi Therapy | 0 | |
| Overall Study | NOT COMPLETED | Cohort B Post BCL-2 Therapy | 0 |
Source ClinicalTrials.gov
Adverse events50
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 | Blurred vision | Eye disorders | Cohort A Post BTKi Therapy | 0 | 0 | 0 |
| other | Blurred vision | Eye disorders | Cohort B Post BCL-2 Therapy | 1 | 1 | 3 |
| other | Dizziness | Nervous system disorders | Cohort A Post BTKi Therapy | 0 | 0 | 0 |
| other | Dizziness | Nervous system disorders | Cohort B Post BCL-2 Therapy | 1 | 1 | 5 |
| other | Headache | Nervous system disorders | Cohort A Post BTKi Therapy | 0 | 0 | 0 |
| other | Headache | Nervous system disorders | Cohort B Post BCL-2 Therapy | 1 | 1 | 7 |
| other | Fatigue | General disorders | Cohort A Post BTKi Therapy | 0 | 0 | 0 |
| other | Fatigue | General disorders | Cohort B Post BCL-2 Therapy | 1 | 1 | 13 |
| other | Lactate dehydrogenase increased | Investigations | Cohort A Post BTKi Therapy | 0 | 0 | 0 |
| other | Lactate dehydrogenase increased | Investigations | Cohort B Post BCL-2 Therapy | 1 | 1 | 6 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A Post BTKi Therapy | 0 | 0 |
| Total, all-cause mortality | Cohort B Post BCL-2 Therapy | 0 | 1 |
| Total, other adverse events | Cohort A Post BTKi Therapy | 0 | 0 |
| Total, other adverse events | Cohort B Post BCL-2 Therapy | 1 | 1 |
| Total, serious adverse events | Cohort A Post BTKi Therapy | 0 | 0 |
| Total, serious adverse events | Cohort B Post BCL-2 Therapy | 1 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04149821
GET https://conductscience.org/api/trials/v1/NCT04149821/events?page=2