Trial · NCT01589302
PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia
NCT01589302, Phase 2, Active not recruiting, Kami Maddocks, MD; results first posted 2019-05-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia. Trials, record NCT01589302. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01589302
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia
- NCT number
- NCT01589302
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 154 participants, actual
- Lead sponsor
- Kami Maddocks, MD
- Conditions
- Prolymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory/Relapsed Chronic Lymphocytic Leukemia
- Interventions
- ibrutinib, Correlative laboratory samples, quality of life assessment
- First posted
- 2012-05-01
- Last updated
- 2026-04-13
- Results first posted
- 2019-05-21
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determine the 2 Year Progression-free Survival (PFS) of Single Agent PCI-32765 in Patients With Relapsed and Refractory CLL. | up to 2 years | We will summarize our findings for this endpoint independently as well within each cohort (del17p vs other cytogenetic groups). We will evaluate the proportion of patients who are progression-free and alive at two years or have gone on to transplant (treatment successes) over the total number of evaluable patients; eligible patients who received at least one dose of therapy are considered evaluable. Assuming that the number of treatment successes as defined above is binomially distributed, we will also include 95% binomial confidence intervals for the estimates corresponding to each cohort. |
| Secondary | Best Overall Response Rate Using the Revised International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Working Group Guidelines | up to 2 years | Responders were subjects who achieved a complete response (CR), partial response (PR) or PR with persistent lymphocytosis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Number of Patients With 6 Month ORR of Single Agent Ibrutinib in Relapsed and Refractory CLL Patients | Up to 6 months | The 6 month overall response rates overall response rate (ORR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
| Secondary | Percentage of Patients With Overall Survival (OS) | 2 years | Time from date of first treatment with ibrutinib until the date of death from any cause or the date of last contact for those alive. |
| Secondary | 2-year Kaplan-Meier Estimate of OS for Relapsed and Refractory CLL Patients Treated With Single Agent PCI-32765 | 2 years | Time from date of first treatment with ibrutinib until the date of progression or death from any cause. Those alive and progression free are censored at the date of last clinical assessment. |
| Secondary | Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Up to 2 years post treatment | Adverse events grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 with the attribution of either definite, possible or probable related. |
| Secondary | Resistance Studies of Ibrutinib | Up to 4 years | Percentage of patients with BTK C481S mutation or PLCG2 mutation |
| Secondary | Decrease in Immune Suppression of CLL Cells | up to 3 months | |
| Secondary | Effectiveness of Ibrutinib Bridging Patients to Allogeneic Stem Cell Transplant and Outcome of Patients Following This Intervention | Up to 2 years | The number of participants with successful Allogenic Stem Cell Transplant |
| Secondary | Cancer-Specific Stress as Measured by the Impact of Event Scale-Revised (IES-R) | Up to 2 years | Cancer-Specific Stress was measured by the Impact of Event Scale-Revised Participants rated the intensity of these feelings using a five-point Likert scale ranging from 0=not at all to 4=extremely. Patients rated the frequency of their feelings or events for the previous week before treatment. The items were summed for a total score that ranged from 0 to 64 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Determine the 2 Year Progression-free Survival (PFS) of Single Agent PCI-32765 in Patients With Relapsed and Refractory CLL. | up to 2 years | There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients | percentage of patients | NUMBER |
| SECONDARY | Best Overall Response Rate Using the Revised International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Working Group Guidelines | up to 2 years | There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients | percentage of patients | NUMBER |
| SECONDARY | Number of Patients With 6 Month ORR of Single Agent Ibrutinib in Relapsed and Refractory CLL Patients | Up to 6 months | There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients | patients | NUMBER |
| SECONDARY | Percentage of Patients With Overall Survival (OS) | 2 years | There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients | percent of patients | NUMBER |
| SECONDARY | 2-year Kaplan-Meier Estimate of OS for Relapsed and Refractory CLL Patients Treated With Single Agent PCI-32765 | 2 years | There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients | percent of patients | NUMBER |
| SECONDARY | Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Up to 2 years post treatment | patients | NUMBER | |
| SECONDARY | Resistance Studies of Ibrutinib | Up to 4 years | percentage of patients | NUMBER | |
| SECONDARY | Decrease in Immune Suppression of CLL Cells | up to 3 months | Data was not collect and analyzed for this outcome measure | ||
| SECONDARY | Effectiveness of Ibrutinib Bridging Patients to Allogeneic Stem Cell Transplant and Outcome of Patients Following This Intervention | Up to 2 years | participants | NUMBER | |
| SECONDARY | Cancer-Specific Stress as Measured by the Impact of Event Scale-Revised (IES-R) | Up to 2 years | Data was reported for start of treatment only | units on a scale | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Determine the 2 Year Progression-free Survival (PFS) of Single Agent PCI-32765 in Patients With Relapsed and Refractory CLL. | Treatment (Ibrutinib) | All patients | 64 | 95% Confidence Interval 57 to 72 | percentage of patients |
| Determine the 2 Year Progression-free Survival (PFS) of Single Agent PCI-32765 in Patients With Relapsed and Refractory CLL. | Treatment (Ibrutinib) | Del(17p) | 64 | 95% Confidence Interval 54 to 75 | percentage of patients |
| Determine the 2 Year Progression-free Survival (PFS) of Single Agent PCI-32765 in Patients With Relapsed and Refractory CLL. | Treatment (Ibrutinib) | non-Del(17p) | 64 | 95% Confidence Interval 54 to 75 | percentage of patients |
| Best Overall Response Rate Using the Revised International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Working Group Guidelines | Treatment (Ibrutinib) | All patients | 63 | 95% Confidence Interval 55 to 70 | percentage of patients |
| Best Overall Response Rate Using the Revised International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Working Group Guidelines | Treatment (Ibrutinib) | Del(17p) | 66 | 95% Confidence Interval 55 to 76 | percentage of patients |
| Best Overall Response Rate Using the Revised International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Working Group Guidelines | Treatment (Ibrutinib) | non-Del(17p) | 59 | 95% Confidence Interval 48 to 70 | percentage of patients |
| Number of Patients With 6 Month ORR of Single Agent Ibrutinib in Relapsed and Refractory CLL Patients | Treatment (Ibrutinib) | All patients | 63 | 95% Confidence Interval 55 to 70 | patients |
| Number of Patients With 6 Month ORR of Single Agent Ibrutinib in Relapsed and Refractory CLL Patients | Treatment (Ibrutinib) | Del(17p) | 66 | 95% Confidence Interval 55 to 76 | patients |
| Number of Patients With 6 Month ORR of Single Agent Ibrutinib in Relapsed and Refractory CLL Patients | Treatment (Ibrutinib) | Non-del(17p) | 59 | 95% Confidence Interval 48 to 70 | patients |
| Percentage of Patients With Overall Survival (OS) | Treatment (Ibrutinib) | All patients | 78 | 95% Confidence Interval 71 to 84 | percent of patients |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Ibrutinib) | 154 | |
| Overall Study | Del17p Patients | Treatment (Ibrutinib) | 76 | |
| Overall Study | Non-Del17p Patients | Treatment (Ibrutinib) | 76 | |
| Overall Study | COMPLETED | Treatment (Ibrutinib) | 152 | |
| Overall Study | NOT COMPLETED | Treatment (Ibrutinib) | 2 |
Source ClinicalTrials.gov
Adverse events158
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 | Anemia | Blood and lymphatic system disorders | Treatment (Ibrutinib) | 43 | 152 | 51 |
| other | Leukocytosis | Blood and lymphatic system disorders | Treatment (Ibrutinib) | 25 | 152 | 29 |
| other | Lymph node pain | Blood and lymphatic system disorders | Treatment (Ibrutinib) | 14 | 152 | 16 |
| other | Atrial Fibrillation | Cardiac disorders | Treatment (Ibrutinib) | 13 | 152 | 15 |
| other | Palpitations | Cardiac disorders | Treatment (Ibrutinib) | 12 | 152 | 15 |
| other | Sinus Bradycardia | Cardiac disorders | Treatment (Ibrutinib) | 24 | 152 | 28 |
| other | Sinus Tachycardia | Cardiac disorders | Treatment (Ibrutinib) | 9 | 152 | 11 |
| other | Ear and Labyrinth disorders | Ear and labyrinth disorders | Treatment (Ibrutinib) | 10 | 152 | 12 |
| other | Hearing impaired | Ear and labyrinth disorders | Treatment (Ibrutinib) | 8 | 152 | 8 |
| other | Vertigo | Ear and labyrinth disorders | Treatment (Ibrutinib) | 8 | 152 | 8 |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Ibrutinib) | ||
| Total, other adverse events | Treatment (Ibrutinib) | 152 | 152 |
| Total, serious adverse events | Treatment (Ibrutinib) | 152 | 152 |
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.
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