Trial · NCT01217749
Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL
NCT01217749, Phase 1, Phase 2, Completed, Pharmacyclics LLC.; results first posted 2015-04-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL. Trials, record NCT01217749. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01217749
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL
- NCT number
- NCT01217749
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 71 participants, actual
- Lead sponsor
- Pharmacyclics LLC.
- Conditions
- B-cell Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocyctic Leukemia, Richter's Transformation
- Interventions
- PCI-32765, ofatumumab
- First posted
- 2010-10-08
- Last updated
- 2015-06-25
- Results first posted
- 2015-04-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Response | The median follow-up time on study for all treated participants is 12.5 (range 0.5-19.6) months | The primary endpoint for the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR), CR with incomplete blood count recovery (Cri), or partial response (PR), according to the guidelines from the International Workshop on Chronic Lymphocytic Leukemia (IWCLL1) published in 2008 for CLL participants and International Working Group for non-Hodgkin's lymphoma (IWG NHL) 2007 criteria for SLL participants, with the modification that treatment-related lymphocytosis will not be considered progressive disease, as evaluated by the investigators. Assessment of disease is based on radiological exams, physical exam, hematological evaluations and, when appropriate, bone marrow results. |
| Primary | Safety During Dose-Limiting Toxicity (DLT) Observation Period | 56 days for Group 1 and 28 days for Group 2 | Number of dose-limiting toxicities observed in the first 6 participants enrolled in treatment Groups 1 and 2 |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) | From first dose of study treatment to within 30 days of last dose or until study closure | Number of participants who had experienced at least one treatment emergent AE |
| Secondary | Progression Free Survival (PFS) at 12 Months | From first dose of study treatment until disease progression, death, or until 12 months | Progressive disease for CLL (Hallek) is characterized by ≥1 of the following: * Appearance of any new lesion, eg lymph nodes (\> 1.5 cm), de novo hepatomegaly or splenomegaly, or other organ infiltrates * Increase of ≥50% * in longest diameter of any previous site * in hepatomegaly or splenomegaly * in blood lymphocytes with ≥5x109/L B cells with enlarging lymph node, liver, or spleen Progressive disease for B cell lymphoma (Cheson) is characterized by any new lesion or increase by ≥ 50% of previously involved sites from nadir: * Appearance of a new lesion(s) \>1.5 cm in any axis, ≥ 50% increase in the SPD of \>1 node, or ≥50% increase in longest diameter of a previously identified node \>1 cm in short axis * Lesions PET+ if FDG-avid lymphoma or PET+ before therapy * 50% increase from nadir in the SPD of any liver or spleen lesions * New or recurrent BM involvement * Increase of ≥50% in blood lymphocytes with ≥5x109/L B cells within enlarging lymph node, liver, or spleen |
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 | Percentage of Participants Achieving Response | The median follow-up time on study for all treated participants is 12.5 (range 0.5-19.6) months | percentage of participants | NUMBER | |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) | From first dose of study treatment to within 30 days of last dose or until study closure | participants | NUMBER | |
| SECONDARY | Progression Free Survival (PFS) at 12 Months | From first dose of study treatment until disease progression, death, or until 12 months | percentage of event free participants | MEAN | |
| PRIMARY | Safety During Dose-Limiting Toxicity (DLT) Observation Period | 56 days for Group 1 and 28 days for Group 2 | participants who experienced DLT | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Response | Group 1 | 92.6 | 95% Confidence Interval 75.7 to 99.1 | percentage of participants | |
| Percentage of Participants Achieving Response | Group 2 | 80.0 | 95% Confidence Interval 56.3 to 94.3 | percentage of participants | |
| Percentage of Participants Achieving Response | Group 3 | 70.8 | 95% Confidence Interval 48.9 to 87.4 | percentage of participants | |
| Number of Participants With Treatment Emergent Adverse Events (AEs) | Group 1 | 27 | participants | ||
| Number of Participants With Treatment Emergent Adverse Events (AEs) | Group 2 | 20 | participants | ||
| Number of Participants With Treatment Emergent Adverse Events (AEs) | Group 3 | 24 | participants | ||
| Progression Free Survival (PFS) at 12 Months | Group 1 | 88.7 | 95% Confidence Interval 69.0 to 96.2 | percentage of event free participants | |
| Progression Free Survival (PFS) at 12 Months | Group 2 | 85.0 | 95% Confidence Interval 60.4 to 94.9 | percentage of event free participants | |
| Progression Free Survival (PFS) at 12 Months | Group 3 | 75.0 | 95% Confidence Interval 52.6 to 87.9 | percentage of event free participants | |
| Safety During Dose-Limiting Toxicity (DLT) Observation Period | Group 1 | 0 | participants who experienced DLT |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 | 27 | |
| Overall Study | STARTED | Group 2 | 20 | |
| Overall Study | STARTED | Group 3 | 24 | |
| Overall Study | COMPLETED | Group 1 | 24 | |
| Overall Study | COMPLETED | Group 2 | 17 | |
| Overall Study | COMPLETED | Group 3 | 22 | |
| Overall Study | NOT COMPLETED | Group 1 | 3 | |
| Overall Study | NOT COMPLETED | Group 2 | 3 | |
| Overall Study | NOT COMPLETED | Group 3 | 2 |
Source ClinicalTrials.gov
Adverse events849
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 | Group 1 | 4 | 27 | |
| other | Neutropenia | Blood and lymphatic system disorders | Group 2 | 5 | 20 | |
| other | Neutropenia | Blood and lymphatic system disorders | Group 3 | 3 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 1 | 7 | 27 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 2 | 2 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 3 | 2 | 24 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Group 1 | 10 | 27 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Group 2 | 5 | 20 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Group 3 | 2 | 24 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Group 1 | 0 | 27 |
1 to 10 of 849Source ClinicalTrials.gov
See all 849 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 | ||
| Total, all-cause mortality | Group 2 | ||
| Total, all-cause mortality | Group 3 | ||
| Total, other adverse events | Group 1 | 27 | 27 |
| Total, other adverse events | Group 2 | 20 | 20 |
| Total, other adverse events | Group 3 | 24 | 24 |
| Total, serious adverse events | Group 1 | 12 | 27 |
| Total, serious adverse events | Group 2 | 9 | 20 |
| Total, serious adverse events | Group 3 | 10 | 24 |
Source ClinicalTrials.gov
Papers4
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/NCT01217749
GET https://conductscience.org/api/trials/v1/NCT01217749/events?page=2