Trial · NCT02874404
TGR-1202 and Ibrutinib in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
NCT02874404, Phase 2, Completed, University of Nebraska; results first posted 2020-02-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TGR-1202 and Ibrutinib in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma. Trials, record NCT02874404. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02874404
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TGR-1202 and Ibrutinib in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- NCT number
- NCT02874404
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- University of Nebraska
- Conditions
- Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma
- Interventions
- Ibrutinib, Laboratory Biomarker Analysis, PI3K-delta Inhibitor TGR-1202
- First posted
- 2016-08-22
- Last updated
- 2023-10-05
- Results first posted
- 2020-02-26
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants With Adverse Events | Up to 112 days (course 4) | Notable serious or recurrent adverse events (SAEs or AEs) of interest occurring across all cycles regardless of attribution assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. |
| Secondary | Overall Response Rate (ORR) | Up to 4 years | ORR is defined as number of patients achieving a best response of complete response or partial response at any disease assessment time point. Response is based on PET/CT (Deauville 3 or less) or CT alone if CR is achieved by PET/CT. Response criteria, modified from the Lugano response criteria. DLBCL is considered FDG avid. Complete response: Complete disappearance of all detectable clinical evidence of disease and definitely disease-related symptoms if present before therapy. Criteria for Partial Response (PR): Regression of measurable disease and no new sites |
| Secondary | Estimated Progression-free Survival (PFS) at 6 Months | Time between study registration and documented progression or death if no progression was observed, assessed up to 4 years (6 Month estimate shown) | PFS is defined as the time between study registration and documented progression or death if no progression was observed. |
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 | Participants With Adverse Events | Up to 112 days (course 4) | percentage of participants | NUMBER | |
| SECONDARY | Overall Response Rate (ORR) | Up to 4 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Estimated Progression-free Survival (PFS) at 6 Months | Time between study registration and documented progression or death if no progression was observed, assessed up to 4 years (6 Month estimate shown) | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With Adverse Events | All Subjects | G 3-4 elevated AST/ALT | 0 | percentage of participants | |
| Participants With Adverse Events | All Subjects | G 3-4 nausea | 15 | percentage of participants | |
| Participants With Adverse Events | All Subjects | G 3-4 diarrhea | 15 | percentage of participants | |
| Overall Response Rate (ORR) | All Patients | Complete Response | 1 | Participants | |
| Overall Response Rate (ORR) | All Patients | Partial Response | 3 | Participants | |
| Estimated Progression-free Survival (PFS) at 6 Months | All Patients | 8 | 95% Confidence Interval 0.5 to 29 | 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 | All Subjects | 13 | |
| Overall Study | COMPLETED | All Subjects | 13 | |
| Overall Study | NOT COMPLETED | All Subjects | 0 |
Source ClinicalTrials.gov
Adverse events44
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 | alanine aminotransferase increased | Investigations | All Patients | 4 | 13 | 8 |
| other | nausea | Gastrointestinal disorders | All Patients | 6 | 13 | 8 |
| other | diarrhea | Gastrointestinal disorders | All Patients | 3 | 13 | 7 |
| other | Aspartate aminotransferase increased | Investigations | All Patients | 4 | 13 | 6 |
| other | alkaline phosphatase increased | General disorders | All Patients | 2 | 13 | 4 |
| other | Fever | General disorders | All Patients | 2 | 13 | 4 |
| other | abdominal pain | Gastrointestinal disorders | All Patients | 2 | 13 | 3 |
| other | cough | Respiratory, thoracic and mediastinal disorders | All Patients | 3 | 13 | 3 |
| other | upper respiratory infection | Infections and infestations | All Patients | 3 | 13 | 3 |
| other | chills | General disorders | All Patients | 2 | 13 | 2 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Patients | 8 | 13 |
| Total, other adverse events | All Patients | 12 | 13 |
| Total, serious adverse events | All Patients | 6 | 13 |
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 |
|---|---|---|---|---|---|
| P30CA036727 | Buffett Cancer Center Support Grant | SWEASY, JOANN B. | UNIVERSITY OF NEBRASKA MEDICAL 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/NCT02874404
GET https://conductscience.org/api/trials/v1/NCT02874404/events?page=2