A Phase 2 interventional study of PCI-32765 in B-cell Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma and Diffuse Well-differentiated Lymphocytic Lymphoma, sponsored by Pharmacyclics LLC.. Completed at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-27.
Sponsored by Pharmacyclics LLC. · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the long-term safety of a fixed-dose, daily regimen of PCI-32765 PO in subjects with B cell lymphoma or chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL).
392 studies on the registry are indexed under Burkitt Lymphoma; 114 are open to participants now.
This study's enrollment of 199 is above the median of 41 across 354 interventional studies indexed under Burkitt Lymphoma.
Browse Burkitt Lymphoma studies →Pharmacyclics LLC. is the lead sponsor of 54 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 9 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: PCI-32765
Dose based on parent protocol
Number of Subjects With Adverse Events
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.
Time frame: 30 days after last dose of study drug, continue up to 6 months
Progressive Disease (PD)
A progressive disease confirmed by a CT scan.
Time frame: 30 days after last dose of study drug, continue up to 6 months
Death Event
All death events are due to AE, progressive disease, and other reasons.
Time frame: 30 days after last dose of study drug
Documented Responses
Investigator-assessed responses were summarized descriptively for subjects with CLL/SLL and listed for subjects with other NHLs based on the efficacy population.
Time frame: 30 days after last dose of study drug, continue up to 6 months
27 July 2010 (the first Patient enrolled) to 31 March 2016 (the Last patient enrolled), Study was approved on June 2010.
| Milestone | A LONG-TERM SAFETY STUDY OF BRUTON'S TYROSINE KINASE (BTK) INH |
|---|---|
| Started | 199 |
| Completed | 106 |
| Not completed | 93 |
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.
| Participants | A LONG-TERM SAFETY STUDY OF BRUTON'S TYROSINE KINASE (BTK) INH |
|---|---|
| Number of Subjects With Adverse Events | 199 |
A progressive disease confirmed by a CT scan.
| Participants | IBRUTINIB/PCI-32765 |
|---|---|
| Progressive Disease (PD) | 70 |
All death events are due to AE, progressive disease, and other reasons.
| Participants | IBRUTINIB/PCI-32765 |
|---|---|
| Death Event | 42 |
Investigator-assessed responses were summarized descriptively for subjects with CLL/SLL and listed for subjects with other NHLs based on the efficacy population.
| Participants | IBRUTINIB/PCI-32765 |
|---|---|
| CLL/SLL | 180 |
| Other NHL | 16 |
| Treatment discontinuation | 3 |
Collected over 8 Years, 5 months. This is a safety longterm follow-up study, it doesn't have any common milestones.. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IBRUTINIB/PCI-32765 | 111/199 (55.8%) | 111/199 (55.8%) | 114/199 (57.3%) |
| Event | IBRUTINIB/PCI-32765 |
|---|---|
| PneumoniaInfections and infestations | 32/199 |
| Atrial fibrillationCardiac disorders | 21/199 |
| CellulitisInfections and infestations | 13/199 |
| SepsisInfections and infestations | 11/199 |
| PyrexiaGeneral disorders | 8/199 |
| Urinary tract infectionInfections and infestations | 6/199 |
| Febrile neutropeniaBlood and lymphatic system disorders | 4/199 |
| Acute kidney injuryRenal and urinary disorders | 4/199 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 4/199 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 4/199 |
| Event | IBRUTINIB/PCI-32765 |
|---|---|
| HypertensionVascular disorders | 67/199 |
| Lymphocyte count decreasedInvestigations | 24/199 |
| NeutropeniaBlood and lymphatic system disorders | 21/199 |
| Neutrophil Count decreasedInvestigations | 17/199 |
| CataractEar and labyrinth disorders | 14/199 |
| ThrombocytopeniaBlood and lymphatic system disorders | 10/199 |
| HyperglycemiaMetabolism and nutrition disorders | 10/199 |
| DiarroheaGastrointestinal disorders | 9/199 |
| Upper Respiratory Track InfectionInfections and infestations | 9/199 |
| White Blood cell count decreasedInvestigations | 8/199 |
A total of 199 subjects were enrolled and received at least 1 dose of study treatment and therefore comprised the safety population which was used for safety analyses.
| Age, Categorical(Participants) | A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inh |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 83 |
| >=65 years | 116 |
| Age, Continuous(Years) | A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inh |
|---|---|
| Mean | 65.6 ± 8.98 |
| Sex: Female, Male(Participants) | A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inh |
|---|---|
| Female | 56 |
| Male | 143 |
| Ethnicity (NIH/OMB)(Participants) | A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inh |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 192 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inh |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 8 |
| White | 185 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inh |
|---|---|
| United States | 199 |
| Estimated creatinine clearance rate (mL/min)(ML/min) | A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inh |
|---|---|
| Mean | 85.55 ± 34.150 |
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