Trial · NCT03776864
Umbralisib and Pembrolizumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
NCT03776864, Phase 2, Terminated, University of Washington; results first posted 2023-05-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Umbralisib and Pembrolizumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma. Trials, record NCT03776864. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03776864
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Umbralisib and Pembrolizumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
- NCT number
- NCT03776864
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Hodgkin's Lymphoma
- Interventions
- Pembrolizumab, Umbralisib
- First posted
- 2018-12-17
- Last updated
- 2023-05-03
- Results first posted
- 2023-05-03
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate | Up to 1 year | Proportion of subjects with relapsed/ refractory classical Hodgkin Lymphoma (CHL) who achieve a complete response (CR) with a regimen of umbralisib (oral, daily) and pembrolizumab (IV, day 1 of 21-day cycles). Per Response Evaluation Criteria Lugano 2014 for target lesions and assessed by PET-CT, Complete Metabolic Response (CMR), Deaville score of 1, 2, or 3 in nodal or extranodal sites with or without residual mass. |
| Secondary | Overall Response Rate | Up to 1 year | Proportion of subjects with relapsed/ refractory classical Hodgkin Lymphoma (CHL) who achieve an overall response (OR) with a regimen of umbralisib (oral, daily) and pembrolizumab (IV, day 1 of 21-day cycles). Per Response Evaluation Criteria Lugano 2014 for target lesions and assessed by PET-CT, Complete Metabolic Response (CMR), Deaville score of 1, 2, or 3 in nodal or extranodal sites with or without residual mass; Partial Metabolic Response, Deauville score of 4 or 5 with reduced uptake compared to baseline and residual mass(es) of any size; No Response or Stable Disease, Deauville score of 4 or 5 with no significant change in FDG uptake from baseline at interim or end of treatment. |
| Secondary | Number of Participants With Adverse Events | Up to 28 days post-treatment, approximately 2 years | Measured via CTCAE v4.0. Incidence of adverse events is defined as the count of participants who experienced an adverse event. |
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 | Complete Response Rate | Up to 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Response Rate | Up to 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Adverse Events | Up to 28 days post-treatment, approximately 2 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response Rate | Treatment (Pembrolizumab, Umbralisib) | 0 | Participants | ||
| Overall Response Rate | Treatment (Pembrolizumab, Umbralisib) | 3 | Participants | ||
| Number of Participants With Adverse Events | Treatment (Pembrolizumab, Umbralisib) | 6 | 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 (Pembrolizumab, Umbralisib) | 6 | |
| Overall Study | COMPLETED | Treatment (Pembrolizumab, Umbralisib) | 6 | |
| Overall Study | NOT COMPLETED | Treatment (Pembrolizumab, Umbralisib) | 0 |
Source ClinicalTrials.gov
Adverse events34
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 Pain | Gastrointestinal disorders | Treatment (Pembrolizumab, Umbralisib) | 2 | 6 | 3 |
| other | Alanine aminotransferase increased | Investigations | Treatment (Pembrolizumab, Umbralisib) | 3 | 6 | 7 |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Pembrolizumab, Umbralisib) | 1 | 6 | 1 |
| other | Anxiety | Psychiatric disorders | Treatment (Pembrolizumab, Umbralisib) | 1 | 6 | 2 |
| other | Aspartate aminotransferase increased | Investigations | Treatment (Pembrolizumab, Umbralisib) | 3 | 6 | 5 |
| other | Blood bilirubin increased | Investigations | Treatment (Pembrolizumab, Umbralisib) | 1 | 6 | 1 |
| other | Constipation | Gastrointestinal disorders | Treatment (Pembrolizumab, Umbralisib) | 1 | 6 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Treatment (Pembrolizumab, Umbralisib) | 3 | 6 | 3 |
| other | Depression | Psychiatric disorders | Treatment (Pembrolizumab, Umbralisib) | 1 | 6 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Pembrolizumab, Umbralisib) | 3 | 6 | 5 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Pembrolizumab, Umbralisib) | 0 | 6 |
| Total, other adverse events | Treatment (Pembrolizumab, Umbralisib) | 6 | 6 |
| Total, serious adverse events | Treatment (Pembrolizumab, Umbralisib) | 0 | 6 |
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 |
|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | 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/NCT03776864
GET https://conductscience.org/api/trials/v1/NCT03776864/events?page=2