Trial · NCT04783415
Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma
NCT04783415, Phase 2, Active not recruiting, City of Hope Medical Center; results first posted 2023-11-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma. Trials, record NCT04783415. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04783415
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma
- NCT number
- NCT04783415
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
- Mantle Cell Lymphoma
- Interventions
- Acalabrutinib, Ublituximab, Umbralisib
- First posted
- 2021-03-05
- Last updated
- 2026-10-06
- Results first posted
- 2023-11-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR) Rate After Induction (Six Cycles) | Participants were assessed at the end of the induction therapy (24 weeks post-baseline). The induction therapy included six 28-day cycles of the study treatment. | Defined as the proportion of response-evaluable participants that achieve a CR at the end of the induction therapy. CR rate after the induction therapy was estimated by the proportion of response-evaluable patients achieving CR after the induction therapy, along with the 95% exact binomial confidence interval. |
| Secondary | Overall Response Rate (ORR) | Participants were followed up to 24 months after the end of protocol therapy. | Defined as the proportion of response-evaluable participants that achieve a best response of either CR or partial response (PR) during protocol therapy. ORR rate after induction therapy was estimated by the proportion of response-evaluable patients achieving ORR after induction therapy, along with the 95% exact binomial confidence interval. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response (CR) Rate After Induction (Six Cycles) | Participants were assessed at the end of the induction therapy (24 weeks post-baseline). The induction therapy included six 28-day cycles of the study treatment. | percentage of participants | NUMBER | |
| SECONDARY | Overall Response Rate (ORR) | Participants were followed up to 24 months after the end of protocol therapy. |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response (CR) Rate After Induction (Six Cycles) | Treatment (Ublituximab, Acalabrutinib, Umbralisib) | 100 | percentage of 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 (Ublituximab, Acalabrutinib, Umbralisib) | 12 | |
| Overall Study | COMPLETED | Treatment (Ublituximab, Acalabrutinib, Umbralisib) | 12 | |
| Overall Study | NOT COMPLETED | Treatment (Ublituximab, Acalabrutinib, Umbralisib) | 0 |
Source ClinicalTrials.gov
Adverse events110
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 | Anemia | Blood and lymphatic system disorders | Treatment (Ublituximab, Acalabrutinib, Umbralisib) | 8 | 12 | 13 |
| other | Palpitations | Cardiac disorders | Treatment (Ublituximab, Acalabrutinib, Umbralisib) | 1 | 12 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Treatment (Ublituximab, Acalabrutinib, Umbralisib) | 5 | 12 | 5 |
| other | Abdominal distension | Gastrointestinal disorders | Treatment (Ublituximab, Acalabrutinib, Umbralisib) | 1 | 12 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Ublituximab, Acalabrutinib, Umbralisib) | 5 | 12 | 7 |
| other | BELCHING | Gastrointestinal disorders | Treatment (Ublituximab, Acalabrutinib, Umbralisib) | 1 | 12 | 1 |
| other | Constipation | Gastrointestinal disorders | Treatment (Ublituximab, Acalabrutinib, Umbralisib) | 3 | 12 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Ublituximab, Acalabrutinib, Umbralisib) | 11 | 12 | 30 |
| other | Dry mouth | Gastrointestinal disorders | Treatment (Ublituximab, Acalabrutinib, Umbralisib) | 1 | 12 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Treatment (Ublituximab, Acalabrutinib, Umbralisib) | 2 | 12 | 2 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Ublituximab, Acalabrutinib, Umbralisib) | 1 | 12 |
| Total, other adverse events | Treatment (Ublituximab, Acalabrutinib, Umbralisib) | 12 | 12 |
| Total, serious adverse events | Treatment (Ublituximab, Acalabrutinib, Umbralisib) | 4 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT04783415
GET https://conductscience.org/api/trials/v1/NCT04783415/events?page=2