Trial · NCT01109069
Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia
NCT01109069, Phase 2, Completed, Pharmacyclics LLC.; results first posted 2020-05-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia. Trials, record NCT01109069. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01109069
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia
- NCT number
- NCT01109069
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 199 participants, actual
- Lead sponsor
- Pharmacyclics LLC.
- Conditions
B-cell Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Diffuse Well-differentiated Lymphocytic Lymphoma, B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma, Waldenstrom Macroglobulinemia, Burkitt Lymphoma, B-Cell Diffuse Lymphoma
- Interventions
- PCI-32765
- First posted
- 2010-04-22
- Last updated
- 2020-05-27
- Results first posted
- 2020-05-07
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 Subjects With Adverse Events | 30 days after last dose of study drug, continue up to 6 months | Subjects were to receive ibrutinib once daily at the dose level the subject was receiving in the parent study until disease progression or unacceptable toxicity. The study included Screening, Treatment (from the first dose until study drug discontinuation), and Follow-up Phases. |
| Secondary | Progressive Disease (PD) | 30 days after last dose of study drug, continue up to 6 months | A progressive disease confirmed by a CT scan. |
| Secondary | Death Event | 30 days after last dose of study drug | All death events are due to AE, progressive disease, and other reasons. |
| Secondary | Documented Responses | 30 days after last dose of study drug, continue up to 6 months | Investigator-assessed responses were summarized descriptively for subjects with CLL/SLL and listed for subjects with other NHLs based on the efficacy population. |
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 Subjects With Adverse Events | 30 days after last dose of study drug, continue up to 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progressive Disease (PD) | 30 days after last dose of study drug, continue up to 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Death Event | 30 days after last dose of study drug | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Documented Responses | 30 days after last dose of study drug, continue up to 6 months | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Number of Subjects With Adverse Events | A LONG-TERM SAFETY STUDY OF BRUTON'S TYROSINE KINASE (BTK) INH | 199 | Participants | ||
| Progressive Disease (PD) | IBRUTINIB/PCI-32765 | 70 | Participants | ||
| Death Event | IBRUTINIB/PCI-32765 | 42 | Participants | ||
| Documented Responses | IBRUTINIB/PCI-32765 | CLL/SLL | 180 | Participants | |
| Documented Responses | IBRUTINIB/PCI-32765 | Other NHL | 16 | Participants | |
| Documented Responses | IBRUTINIB/PCI-32765 | Treatment discontinuation | 3 | 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 | A LONG-TERM SAFETY STUDY OF BRUTON'S TYROSINE KINASE (BTK) INH | 199 | |
| Overall Study | COMPLETED | A LONG-TERM SAFETY STUDY OF BRUTON'S TYROSINE KINASE (BTK) INH | 106 | |
| Overall Study | NOT COMPLETED | A LONG-TERM SAFETY STUDY OF BRUTON'S TYROSINE KINASE (BTK) INH | 93 |
Source ClinicalTrials.gov
Adverse events181
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 | Neutropenia | Blood and lymphatic system disorders | IBRUTINIB/PCI-32765 | 21 | 199 | 24 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | IBRUTINIB/PCI-32765 | 10 | 199 | 23 |
| other | Cataract | Ear and labyrinth disorders | IBRUTINIB/PCI-32765 | 14 | 199 | 20 |
| other | Diarrohea | Gastrointestinal disorders | IBRUTINIB/PCI-32765 | 9 | 199 | 10 |
| other | Upper Respiratory Track Infection | Infections and infestations | IBRUTINIB/PCI-32765 | 9 | 199 | 10 |
| other | Lymphocyte count decreased | Investigations | IBRUTINIB/PCI-32765 | 24 | 199 | 59 |
| other | Neutrophil Count decreased | Investigations | IBRUTINIB/PCI-32765 | 17 | 199 | 32 |
| other | White Blood cell count decreased | Investigations | IBRUTINIB/PCI-32765 | 8 | 199 | 12 |
| other | Hyperglycemia | Metabolism and nutrition disorders | IBRUTINIB/PCI-32765 | 10 | 199 | 15 |
| other | Hypertension | Vascular disorders | IBRUTINIB/PCI-32765 | 67 | 199 | 197 |
1 to 10 of 181Source ClinicalTrials.gov
See all 181 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IBRUTINIB/PCI-32765 | 111 | 199 |
| Total, other adverse events | IBRUTINIB/PCI-32765 | 114 | 199 |
| Total, serious adverse events | IBRUTINIB/PCI-32765 | 111 | 199 |
Source ClinicalTrials.gov
Papers3
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 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/NCT01109069
GET https://conductscience.org/api/trials/v1/NCT01109069/events?page=2