Trial · NCT04508647
Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma
NCT04508647, Phase 2, Completed, University of Colorado, Denver; results first posted 2023-11-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma. Trials, record NCT04508647. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04508647
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma
- NCT number
- NCT04508647
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Marginal Zone Lymphoma, Follicular Lymphoma
- Interventions
- Ublituximab, Umbralisib
- First posted
- 2020-08-11
- Last updated
- 2024-03-21
- Results first posted
- 2023-11-09
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Complete Response Rate (CR) at 8 Weeks Post Single Agent Induction | 8 weeks post induction | Number of subjects that reached a complete response at the end of single agent induction as defined by a Lugano score of 3 or less on arm MONO - Monotherapy: Ublituximab. Complete response assessed via PET CT scan utilizing the Lugano-Deauville Criteria where none of the lymphoma lesions had FDG ( FluoroDeoxyglucose) avidity greater than the liver uptake. Patients who did not reach complete response at this point were then bridged to arm COMBO - Combotherapy: Ublituximab + Umbralisib. |
| Primary | Number of Participants With Complete Response Rate (CR) at up to 12 Months Post MONO - Monotherapy: Ublituximab or Combotherapy: Ublituximab + Umbralisib. | up to 12 months post induction | Number of subjects that reached a complete response at up to 12 months post induction as defined by a Lugano score of 3 or less on arms MONO - Monotherapy: Ublituximab.OR Combotherapy: Ublituximab + Umbralisib. Complete response assessed via PET CT scan utilizing the Lugano-Deauville Criteria where none of the lymphoma lesions had FDG ( FluoroDeoxyglucose) avidity greater than the liver uptake. |
| Secondary | Overall Response Rates (ORR) for Number of Participants | up to 12 months post induction | Overall Response Rate for number of subjects as defined by a Lugano score of 3 or less on arms MONO - Monotherapy: Ublituximab.OR Combotherapy: Ublituximab + Umbralisib. Overall response rate assessed via PET CT utilizing Lugano deauvile criteria where lymphoma lesions had responded and would include complete response, partial response (\> 50% improvement) and stable disease (less than 50 % response) |
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 | Number of Participants With Complete Response Rate (CR) at 8 Weeks Post Single Agent Induction | 8 weeks post induction | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Complete Response Rate (CR) at up to 12 Months Post MONO - Monotherapy: Ublituximab or Combotherapy: Ublituximab + Umbralisib. | up to 12 months post induction | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Response Rates (ORR) for Number of Participants | up to 12 months post induction | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Complete Response Rate (CR) at 8 Weeks Post Single Agent Induction | Ublituximab Only | 2 | Participants | ||
| Number of Participants With Complete Response Rate (CR) at up to 12 Months Post MONO - Monotherapy: Ublituximab or Combotherapy: Ublituximab + Umbralisib. | Ublituximab Only | 2 | Participants | ||
| Number of Participants With Complete Response Rate (CR) at up to 12 Months Post MONO - Monotherapy: Ublituximab or Combotherapy: Ublituximab + Umbralisib. | Ublituximab First, Then Ublituximab and Umbralisib | 2 | Participants | ||
| Overall Response Rates (ORR) for Number of Participants | Ublituximab Only | 2 | Participants | ||
| Overall Response Rates (ORR) for Number of Participants | Ublituximab First, Then Ublituximab and Umbralisib | 2 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Cycle 1: Baseline to 8 Weeks | STARTED | Ublituximab Only | 4 | |
| Cycle 1: Baseline to 8 Weeks | STARTED | Ublituximab First, Then Ublituximab and Umbralisib | 0 | |
| Cycle 1: Baseline to 8 Weeks | COMPLETED | Ublituximab Only | 4 | |
| Cycle 1: Baseline to 8 Weeks | COMPLETED | Ublituximab First, Then Ublituximab and Umbralisib | 0 | |
| Cycle 1: Baseline to 8 Weeks | NOT COMPLETED | Ublituximab Only | 0 | |
| Cycle 1: Baseline to 8 Weeks | NOT COMPLETED | Ublituximab First, Then Ublituximab and Umbralisib | 0 | |
| Cycle 2: 8 Weeks to 12 Months | STARTED | Ublituximab Only | 2 | |
| Cycle 2: 8 Weeks to 12 Months | STARTED | Ublituximab First, Then Ublituximab and Umbralisib | 2 | |
| Cycle 2: 8 Weeks to 12 Months | COMPLETED | Ublituximab Only | 2 | |
| Cycle 2: 8 Weeks to 12 Months | COMPLETED | Ublituximab First, Then Ublituximab and Umbralisib | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events58
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 | Abdominal Distension | Gastrointestinal disorders | Ublituximab Only | 1 | 2 | 1 |
| other | Abdominal Distension | Gastrointestinal disorders | Ublituximab First, Then Ublituximab and Umbralisib | 0 | 2 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Ublituximab Only | 0 | 2 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Ublituximab First, Then Ublituximab and Umbralisib | 1 | 2 | 1 |
| other | Alanine Aminotransferase Increased | Blood and lymphatic system disorders | Ublituximab Only | 0 | 2 | 0 |
| other | Alanine Aminotransferase Increased | Blood and lymphatic system disorders | Ublituximab First, Then Ublituximab and Umbralisib | 1 | 2 | 1 |
| other | Back Pain | General disorders | Ublituximab Only | 0 | 2 | 0 |
| other | Back Pain | General disorders | Ublituximab First, Then Ublituximab and Umbralisib | 1 | 2 | 1 |
| other | volare bleeding | Blood and lymphatic system disorders | Ublituximab Only | 0 | 2 | 0 |
| other | volare bleeding | Blood and lymphatic system disorders | Ublituximab First, Then Ublituximab and Umbralisib | 1 | 2 | 1 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ublituximab Only | 0 | 2 |
| Total, all-cause mortality | Ublituximab First, Then Ublituximab and Umbralisib | 0 | 2 |
| Total, other adverse events | Ublituximab Only | 2 | 2 |
| Total, other adverse events | Ublituximab First, Then Ublituximab and Umbralisib | 2 | 2 |
| Total, serious adverse events | Ublituximab Only | 0 | 2 |
| Total, serious adverse events | Ublituximab First, Then Ublituximab and Umbralisib | 0 | 2 |
Source ClinicalTrials.gov
Papers32
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Ublituximab Only vs Ublituximab First, Then Ublituximab and Umbralisib: Number of Participants With Complete Response Rate (CR) at up to 12 Months Post MONO - Monotherapy: Ublituximab or Combotherapy: Ublituximab + Umbralisib. | Trial comparisons |
| Ublituximab Only vs Ublituximab First, Then Ublituximab and Umbralisib: Overall Response Rates (ORR) for Number of Participants | Trial comparisons |
| Ublituximab Only vs Ublituximab First, Then Ublituximab and Umbralisib: deaths from any cause | Trial comparisons |
| Ublituximab Only vs Ublituximab First, Then Ublituximab and Umbralisib: serious adverse events | Trial comparisons |
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/NCT04508647
GET https://conductscience.org/api/trials/v1/NCT04508647/events?page=2