Trial · NCT04016805
Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax
NCT04016805, Phase 2, Terminated, TG Therapeutics, Inc.; results first posted 2023-07-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax. Trials, record NCT04016805. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04016805
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax
- NCT number
- NCT04016805
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- TG Therapeutics, Inc.
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Ublituximab, Umbralisib, Ibrutinib, Venetoclax, Acalabrutinib Oral Capsule
- First posted
- 2019-07-11
- Last updated
- 2023-07-24
- Results first posted
- 2023-07-24
- Limitations and caveats
Due to sponsor's business decision, the clinical trial was terminated by the sponsor prematurely. No analysis was done at the termination of the trial, therefore, outcome, and safety data are not available and the numbers of participants analyzed are reported as 0.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Undetected Minimal Residual Disease (U-MRD) | Up to approximately 23 months | U-MRD rate was defined as the proportion of participants who have undetectable MRD in the peripheral blood as confirmed by central lab. |
| Secondary | Overall Response Rate (ORR) | Up to approximately 34 months | ORR was defined as percent of participants who achieve complete response (CR) or partial response (PR). CR was defined as no evidence of new disease, regression of all target nodal masses to normal size \< or = 1.5 cm in the longest diameter (LD) and an absolute lymphocyte count (ALC) in peripheral blood \< 4\*10\^9/L. PR was defined as no evidence of new disease, a decrease in peripheral blood ALC by ≥50% from baseline or a decrease to \<4 x 10\^9/L or a decrease by ≥50% from the baseline in the sum of the products (SPD) of the target nodal lesions or a decrease by ≥50% from baseline in the CLL marrow infiltrate or in B lymphoid, no target, splenic, liver, or non-target disease with worsening that meets the criteria for definitive nodules, peripheral blood counts with ANC \>1.5 x 10\^9/L or platelet count ≥100 x 10\^9/L or hemoglobin ≥110 g/L (11.0 g/dL) without red blood cell transfusions, all without need for exogenous growth factors. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5) | Up to approximately 34 months | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE is an AE that starts or worsens after receiving study drug. |
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 | Rate of Undetected Minimal Residual Disease (U-MRD) | Up to approximately 23 months | Data for this outcome measure was not collected or analyzed as planned as the study was terminated due to sponsor's business decision. | ||
| SECONDARY | Overall Response Rate (ORR) | Up to approximately 34 months | Data for this outcome measure was not collected or analyzed as planned as the study was terminated due to sponsor's business decision. | ||
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5) | Up to approximately 34 months | Data for this outcome measure was not collected or analyzed as planned as the study was terminated due to sponsor's business decision. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ublituximab + Umbralisib + Ibrutinib | 30 | |
| Overall Study | STARTED | Ublituximab + Umbralisib + Venetoclax | 6 | |
| Overall Study | STARTED | Ublituximab + Umbralisib + Acalabrutinib | 5 | |
| Overall Study | COMPLETED | Ublituximab + Umbralisib + Ibrutinib | 0 | |
| Overall Study | COMPLETED | Ublituximab + Umbralisib + Venetoclax | 0 | |
| Overall Study | COMPLETED | Ublituximab + Umbralisib + Acalabrutinib | 0 | |
| Overall Study | NOT COMPLETED | Ublituximab + Umbralisib + Ibrutinib | 30 | |
| Overall Study | NOT COMPLETED | Ublituximab + Umbralisib + Venetoclax | 6 | |
| Overall Study | NOT COMPLETED | Ublituximab + Umbralisib + Acalabrutinib | 5 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ublituximab + Umbralisib + Ibrutinib | 0 | 0 |
| Total, all-cause mortality | Ublituximab + Umbralisib + Venetoclax | 0 | 0 |
| Total, all-cause mortality | Ublituximab + Umbralisib + Acalabrutinib | 0 | 0 |
| Total, other adverse events | Ublituximab + Umbralisib + Ibrutinib | 0 | 0 |
| Total, other adverse events | Ublituximab + Umbralisib + Venetoclax | 0 | 0 |
| Total, other adverse events | Ublituximab + Umbralisib + Acalabrutinib | 0 | 0 |
| Total, serious adverse events | Ublituximab + Umbralisib + Ibrutinib | 0 | 0 |
| Total, serious adverse events | Ublituximab + Umbralisib + Venetoclax | 0 | 0 |
| Total, serious adverse events | Ublituximab + Umbralisib + Acalabrutinib | 0 | 0 |
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/NCT04016805
GET https://conductscience.org/api/trials/v1/NCT04016805/registered