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
CompletedPhase 3Results postedLast updated 19 January 2018
What this trial tests
Phase 3 trial testing Ibrutinib in Mantle Cell Lymphoma in 280 participants. Completed in 15 December 2016.
18 and older, any sex, with Mantle Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free Survival (PFS)Primary· 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).
Group
Value
95% CI
Ibrutinib
15.6
10.6 – 25.1
Temsirolimus
6.2
4.2 – 7.8
Overall Response Rate (ORR)Secondary· 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.
Group
Value
95% CI
Ibrutinib
77.0
Temsirolimus
46.8
Overall Survival (OS)Secondary· 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.
Group
Value
95% CI
Ibrutinib
30.3
19.1 – 42.1
Temsirolimus
23.5
13.0 – 30.7
Duration of ResponseSecondary· 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.
Group
Value
95% CI
Ibrutinib
23.1
16.2 – 28.1
Temsirolimus
6.3
4.7 – 8.6
Time-to-Next TreatmentSecondary· 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.
Group
Value
95% CI
Ibrutinib
31.8
23.3 – NA
Temsirolimus
11.6
8.0 – 13.3
Progression-Free Survival 2Secondary· 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.
Group
Value
95% CI
Ibrutinib
26.2
17.2 – 32.4
Temsirolimus
15.4
10.2 – 21.3
Time to Worsening in the Lymphoma Sub Scale of Functional Assessment of Cancer Therapy- Lymphoma (FACT-Lym)Secondary· 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.
Group
Value
95% CI
Ibrutinib
NA
81.4 – NA
Temsirolimus
10.6
6.6 – 15.3
Number of Participants Affected With Treatment-emergent Adverse EventsSecondary· 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.
Group
Value
95% CI
Ibrutinib
139
Temsirolimus
138
Time to ResponseSecondary· 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.
Group
Value
95% CI
Ibrutinib
2.15
0.5 – 10.4
Temsirolimus
2.14
0.9 – 12.0
Extent of Exposure of TimeSecondary· 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.
Group
Value
95% CI
Ibrutinib
14.39
0.0 – 46.8
Temsirolimus
3.02
0.0 – 31.4
One Year Survival RateSecondary· Month 12
One -year survival rate, defined as the proportion of participants who were alive 1 year after randomization.
Group
Value
95% CI
Ibrutinib
0.68
0.59 – 0.75
Temsirolimus
0.61
0.52 – 0.69
Area Under the Plasma Concentration of Ibrutinib During Steady State (AUC-ss)Secondary· Cycle 1 and 2 (Day 1): Predose, 1, 2, 4 hr. postdose; Cycle 3 (day 1): Predose (Each cycle is of 21 days)
The AUC-ss is the area under the plasma concentration time curve observed during steady state.
Group
Value
95% CI
Ibrutinib
561.6
± 448
Adverse events — posted to ClinicalTrials.gov
Time frame: Approximately up to 4 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus temsirolimus in patients with relapsed or refractory mantle cell lymphoma who received at least 1 prior chemotherapy regimen.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel
· Phase 3
· recruiting
NCT06649812 — Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggress
· Phase 2
· recruiting
NCT07169565 — Ibrutinib Followed by BR (Bendamustine and Rituximab) as a Time-Limited Therapy for Waldenström Macroglobulinemia
· Phase 1
· not yet recruiting
NCT06357676 — Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial
· Phase 1, PHASE2
· recruiting
Other recruiting trials for Mantle Cell Lymphoma
Currently open trials in the same condition.
NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel
· Phase 3
· recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr
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· recruiting
NCT06839053 — Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic L
· Phase 2
· recruiting
NCT06357676 — Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial
· Phase 1, PHASE2
· recruiting
NCT06854003 — BRAZAN: A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Fo
· Phase 2
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
Last refreshed: 19 January 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01646021.