Trial · NCT01646021
Study of Ibrutinib (a Bruton's Tyrosine Kinase Inhibitor), Versus Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy
NCT01646021, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2017-03-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Ibrutinib (a Bruton's Tyrosine Kinase Inhibitor), Versus Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy. Trials, record NCT01646021. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01646021
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Ibrutinib (a Bruton's Tyrosine Kinase Inhibitor), Versus Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy
- NCT number
- NCT01646021
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 280 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Mantle Cell Lymphoma
- Interventions
- Ibrutinib, Temsirolimus
- First posted
- 2012-07-20
- Last updated
- 2018-01-19
- Other registries' IDs
- eudract:2012-000601-74
- Results first posted
- 2017-03-01
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Time from the date of randomization until the date of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death, whichever occurred first (approximately 48 months) | PFS is defined as the duration in months from the date of randomization to the date of progression disease (PD) or relapse from complete response (CR) or death whichever was reported first and was assessed based on the investigator assessment. Revised Response Criteria for Malignant Lymphoma categorizes the response of the treatment of a patient's tumour to CR (the disappearance of all evidence of disease), Relapsed Disease or PD (Any new lesion or increase by greater than or equal to \[\>=\] 50 percent \[%\] of previously involved sites from nadir). |
| Secondary | Overall Response Rate (ORR) | Approximately up to 48 months | ORR is defined as the percentage of participants who achieved either CR or PR as best overall response based on the investigator assessment. CR is Disappearance of all target lesions while PR is greater than or equal to 30 % decrease in the sum of the longest diameter of target lesions and Overall Response (OR) is sum of CR and PR. |
| Secondary | Overall Survival (OS) | Approximately up to 48 months | Overall survival (OS) was defined as the interval between the date of randomization and the date of death from any cause. |
| Secondary | Duration of Response | Approximately up to 48 months | Duration of response (CR or PR), defined as the duration in days from the date of initial response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death. The analysis was based on the investigator assessment. |
| Secondary | Time-to-Next Treatment | Approximately up to 48 months | Time to next treatment was measured from the date of randomization to the start date of any anti-neoplastic treatment subsequent to study treatment. |
| Secondary | Progression-Free Survival 2 | Approximately up to 48 months | Progression-free survival 2 defined as the time interval between the date of randomization and date of event, defined as progressive disease as assessed by investigator that started after the next line of subsequent anti-neoplastic therapy (including cross-over to ibrutinib), death from any cause, or the start of the second subsequent anti-neoplastic therapy if no progressive disease was recorded after the first subsequent anti-neoplastic therapy. |
| Secondary | Time to Worsening in the Lymphoma Sub Scale of Functional Assessment of Cancer Therapy- Lymphoma (FACT-Lym) | Approximately up to 48 months | Time to worsening in the Lymphoma subscale of the FACT-Lym, defined as the interval from the date of randomization to the start date of worsening. Worsening was defined by a 5-point decrease from baseline. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (higher the worse). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life. |
| Secondary | Number of Participants Affected With Treatment-emergent Adverse Events | Time from first dose of study drug until the last dose date + 30 days or the start of a subsequent anti-neoplastic therapy, whichever occur earlier (Approximately up to 4 years) | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Other | Time to Response | Approximately up to 2.8 years | Time to response for participants with CR/PR, defined as the interval between the date of randomization and date of initial documentation of response. |
| Other | Extent of Exposure of Time | Approximately up to 46.8 months | Extent of exposure is defined as the duration of the treatment administered during the study. Duration of exposure is calculated as the number of months between the start and end of treatment. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | Time from the date of randomization until the date of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death, whichever occurred first (approximately 48 months) | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | Approximately up to 48 months | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Approximately up to 48 months | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. | Months | MEDIAN |
| SECONDARY | Duration of Response | Approximately up to 48 months | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. The 'N' (number of participants analyzed) signifies the number of participants responded for this outcome measure. | Months | MEDIAN |
| SECONDARY | Time-to-Next Treatment | Approximately up to 48 months | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival 2 | Approximately up to 48 months | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. | Months | MEDIAN |
| SECONDARY | Time to Worsening in the Lymphoma Sub Scale of Functional Assessment of Cancer Therapy- Lymphoma (FACT-Lym) | Approximately up to 48 months | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. | Weeks | MEDIAN |
| SECONDARY | Number of Participants Affected With Treatment-emergent Adverse Events | Time from first dose of study drug until the last dose date + 30 days or the start of a subsequent anti-neoplastic therapy, whichever occur earlier (Approximately up to 4 years) | Safety population included all randomized participants who received at least 1 dose of the study drug. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Time to Response | Approximately up to 2.8 years | The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. The 'N' (number of participants analyzed) signifies the number of participants responded for this outcome measure. | Months | MEDIAN |
| OTHER_PRE_SPECIFIED | Extent of Exposure of Time | Approximately up to 46.8 months | Safety Analyses Set (SAS) population includes all the randomized participants who received at least 1 dose of study agent (ibrutinib or temsirolimus) during the treatment phase. | Months | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group63
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Ibrutinib | 15.6 | 95% Confidence Interval 10.6 to 25.1 | Months | |
| Progression Free Survival (PFS) | Temsirolimus | 6.2 | 95% Confidence Interval 4.2 to 7.8 | Months | |
| Overall Response Rate (ORR) | Ibrutinib | 77.0 | Percentage of participants | ||
| Overall Response Rate (ORR) | Temsirolimus | 46.8 | Percentage of participants | ||
| Overall Survival (OS) | Ibrutinib | 30.3 | 95% Confidence Interval 19.1 to 42.1 | Months | |
| Overall Survival (OS) | Temsirolimus | 23.5 | 95% Confidence Interval 13.0 to 30.7 | Months | |
| Duration of Response | Ibrutinib | 23.1 | 95% Confidence Interval 16.2 to 28.1 | Months | |
| Duration of Response | Temsirolimus | 6.3 | 95% Confidence Interval 4.7 to 8.6 | Months | |
| Time-to-Next Treatment | Ibrutinib | 31.8 | 95% Confidence Interval 23.3 to NA | Months | |
| Time-to-Next Treatment | Temsirolimus | 11.6 | 95% Confidence Interval 8.0 to 13.3 | Months |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibrutinib | 139 | |
| Overall Study | STARTED | Temsirolimus | 141 | |
| Overall Study | Treated | Ibrutinib | 139 | |
| Overall Study | Treated | Temsirolimus | 139 | |
| Overall Study | COMPLETED | Ibrutinib | 0 | |
| Overall Study | COMPLETED | Temsirolimus | 0 | |
| Overall Study | NOT COMPLETED | Ibrutinib | 139 | |
| Overall Study | NOT COMPLETED | Temsirolimus | 141 |
Source ClinicalTrials.gov
Adverse events504
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 | Anaemia | Blood and lymphatic system disorders | Ibrutinib | 27 | 139 | |
| other | Anaemia | Blood and lymphatic system disorders | Temsirolimus | 57 | 139 | |
| other | Neutropenia | Blood and lymphatic system disorders | Ibrutinib | 21 | 139 | |
| other | Neutropenia | Blood and lymphatic system disorders | Temsirolimus | 36 | 139 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ibrutinib | 25 | 139 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Temsirolimus | 77 | 139 | |
| other | Atrial Fibrillation | Cardiac disorders | Ibrutinib | 8 | 139 | |
| other | Atrial Fibrillation | Cardiac disorders | Temsirolimus | 1 | 139 | |
| other | Cataract | Eye disorders | Ibrutinib | 2 | 139 | |
| other | Cataract | Eye disorders | Temsirolimus | 7 | 139 |
1 to 10 of 504Source ClinicalTrials.gov
See all 504 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibrutinib | 130 | 139 |
| Total, all-cause mortality | Temsirolimus | 137 | 139 |
| Total, other adverse events | Ibrutinib | 130 | 139 |
| Total, other adverse events | Temsirolimus | 137 | 139 |
| Total, serious adverse events | Ibrutinib | 79 | 139 |
| Total, serious adverse events | Temsirolimus | 83 | 139 |
Source ClinicalTrials.gov
Papers2
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Ibrutinib vs Temsirolimus: Number of Participants With Biomarkers That Alter B-cell Receptor (BCR) Signaling or Activate Alternative Signaling Pathways and to Explore Their Association With Response or Resistance to Ibrutinib | Trial comparisons |
| Ibrutinib vs Temsirolimus: Number of Participants Affected With Treatment-emergent Adverse Events | Trial comparisons |
| Ibrutinib vs Temsirolimus: deaths from any cause | Trial comparisons |
| Ibrutinib vs Temsirolimus: serious adverse events | Trial comparisons |
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.
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