Trial · NCT03121534
Ibrutinib, Nivolumab and Blinatumomab in Richter Transformation
NCT03121534, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2023-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ibrutinib, Nivolumab and Blinatumomab in Richter Transformation. Trials, record NCT03121534. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03121534
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ibrutinib, Nivolumab and Blinatumomab in Richter Transformation
- NCT number
- NCT03121534
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Hematopoietic/Lymphoid Cancer, Richter's Transformation
- Interventions
- Blinatumomab, Dexamethasone, Ibrutinib, Nivolumab
- First posted
- 2017-04-20
- Last updated
- 2023-02-17
- Results first posted
- 2023-02-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Response | 2 months | Response is defined as complete remission (CR) plus partial remission (PR). Complete Remission (CR) is Lymph nodes None \>/= 1.5 cm, Spleen size \< 13 cm; normal liver size, the absence of constitutional symptoms, normal circulating lymphocyte count, platelets \>/= 100 x 10\^9/L, Hemoglobin \>/= 11.0 g/dL (absence of transfusion and without erythropoietin) and marrow normocellular, no CLL cells and no B-lymphoid nodules. Partial Remission (PR) is any two of the following must decrease \>/= 50% from baseline: lymph nodes, Liver and/or spleen size, circulating lymphocyte count in addition to one of the following: platelets \>/= 100 x 10\^9/L or \>/= 50% increase from baseline, Hemoglobin \>/= 11.0 g/dL or \>/= 50% increase from baseline or marrow presence of CLL cells, or of B-lymphoid nodules, or not done. |
| Secondary | Number of Participants to Achieve Complete Remission | Up to 4 years, 8 months | Complete Remission is defined as: Complete Remission (CR) is Lymph nodes None \>/= 1.5 cm, Spleen size \< 13 cm; normal liver size, the absence of constitutional symptoms, normal circulating lymphocyte count, platelets \>/= 100 x 10\^9/L, Hemoglobin \>/= 11.0 g/dL (absence of transfusion and without erythropoietin) and marrow normocellular, no CLL cells and no B-lymphoid nodules. |
| Secondary | Progression Free Survival | Up to 4 years, 8 months | Time from date of treatment start until the date of first objective documentation of disease-relapse. |
| Secondary | Overall Survival | Up to 4 years, 8 Months | Time from date of treatment start until date of death due to any cause or last Follow-up. |
Source ClinicalTrials.gov
Outcomes4
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 a Response | 2 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants to Achieve Complete Remission | Up to 4 years, 8 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression Free Survival | Up to 4 years, 8 months | months | MEDIAN | |
| SECONDARY | Overall Survival | Up to 4 years, 8 Months | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group4
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 a Response | Ibrutinib, Nivolumab and Blinatumomab | 2 | Participants | ||
| Number of Participants to Achieve Complete Remission | Ibrutinib, Nivolumab and Blinatumomab | 1 | Participants | ||
| Progression Free Survival | Ibrutinib, Nivolumab and Blinatumomab | 1.9 | Full Range 1 to 17 | months | |
| Overall Survival | Ibrutinib, Nivolumab and Blinatumomab | 10.3 | Full Range 5 to 48 | Months |
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 | Ibrutinib, Nivolumab and Blinatumomab | 9 | |
| Overall Study | COMPLETED | Ibrutinib, Nivolumab and Blinatumomab | 9 | |
| Overall Study | NOT COMPLETED | Ibrutinib, Nivolumab and Blinatumomab | 0 |
Source ClinicalTrials.gov
Adverse events67
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 | Ibrutinib, Nivolumab and Blinatumomab | 1 | 9 | 1 |
| other | Alanine aminotransferase increased | Investigations | Ibrutinib, Nivolumab and Blinatumomab | 2 | 9 | 2 |
| other | Alkaline phosphatase increased | Investigations | Ibrutinib, Nivolumab and Blinatumomab | 3 | 9 | 3 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Ibrutinib, Nivolumab and Blinatumomab | 1 | 9 | 1 |
| other | Anorexia | Gastrointestinal disorders | Ibrutinib, Nivolumab and Blinatumomab | 1 | 9 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Ibrutinib, Nivolumab and Blinatumomab | 1 | 9 | 1 |
| other | Aspartate aminotransferase increased | Investigations | Ibrutinib, Nivolumab and Blinatumomab | 1 | 9 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Ibrutinib, Nivolumab and Blinatumomab | 1 | 9 | 1 |
| other | Blood bilirubin increased | Investigations | Ibrutinib, Nivolumab and Blinatumomab | 1 | 9 | 1 |
| other | Bruising | Skin and subcutaneous tissue disorders | Ibrutinib, Nivolumab and Blinatumomab | 1 | 9 | 1 |
1 to 10 of 67Source ClinicalTrials.gov
See all 67 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibrutinib, Nivolumab and Blinatumomab | 0 | 9 |
| Total, other adverse events | Ibrutinib, Nivolumab and Blinatumomab | 9 | 9 |
| Total, serious adverse events | Ibrutinib, Nivolumab and Blinatumomab | 9 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35941212 | DERIVED |
Source PubMed
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/NCT03121534
GET https://conductscience.org/api/trials/v1/NCT03121534/events?page=2