18 and older, any sex, with Relapsed Diffuse Large B-Cell Lymphoma or Refractory Diffuse Large B-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.
Phase 1b: Recommended Phase 2 Dose of Lenalidomide in Combination With Fixed Doses of Ibrutinib and Rituximab in Participants With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)Primary· Estimated median time on study in Phase 1b was 59.6 months.
The dose levels of lenalidomide were explored, and dose escalation of lenalidomide followed the 3+3+3 dose escalation schema. A Dose Level Review Committee evaluated safety data following completion of each dose observation period of the Phase 1b portion.
Group
Value
95% CI
All Phase 1b Participants
20
Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEsPrimary· From first dose of study drug up to 30 days after last dose of study drug. Phase 1b median duration of ibrutinib exposure was 4.4 months; median duration of lenalidomide exposure was 4.4 months; median total number of doses of rituximab received was 4.0.
An adverse event (AE) is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious AE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization \> 24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. AEs that started or worsened during the treatment-emergent period and all possibly related or related AEs were considered TEAEs. Related events w
Phase 2: Overall Response Rate (ORR)Primary· Estimated median time on study in Phase 2 was 35.0 months.
The ORR was defined as the percentage of participants who achieve either a partial response (PR) or complete response (CR), according to the Revised International Working Group Response Criteria for Malignant Lymphoma or Lugano Classification (Cheson 2014), as assessed by the investigator in response-evaluable population. The 95% confidence interval (CI) was calculated using the exact method.
Group
Value
95% CI
Phase 2: Enrolled at Lenalidomide Dose 20 mg
52.8
38.6 – 66.7
Phase 2: Enrolled at Lenalidomide Dose 25 mg
43.8
26.4 – 62.3
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
49.4
38.4 – 60.5
Phase 1b: ORRSecondary· Estimated median time on study in Phase 1b was 59.6 months.
The ORR was defined as the percentage of participants who achieve either a PR or CR, according to the Revised International Working Group Response Criteria for Malignant Lymphoma (Cheson 2007), as assessed by the Investigator in response-evaluable population, where CR=disappearance of all evidence of disease and PR=regression of measurable disease and no new sites. The 95% CI was calculated using the exact method.
Phase 1b Total: Enrolled at Lenalidomide Dose 10 to 25 mg (All Dose Levels)
42.5
27.0 – 59.1
Phase 1b: Complete Response (CR) RateSecondary· Estimated median time on Phase 1b study was 59.6 months.
The CR rate was defined as the percentage of participants who achieve a CR, according to the Revised International Working Group Response Criteria for Malignant Lymphoma (Cheson 2007), as assessed by the Investigator in response-evaluable population, where CR=disappearance of all evidence of disease, as assessed by the Investigator.
Phase 1b Total: Enrolled at Lenalidomide Dose 10 to 25 mg (All Dose Levels)
27.5
Phase 2: CR RateSecondary· Estimated median time on study in Phase 2 was 35.0 months.
The CR rate was defined as the percentage of participants who achieve a CR, according to the Revised International Working Group Response Criteria for Malignant Lymphoma or Lugano Classification (see Cheson, 2014 for detailed criteria) in response-evaluable population, as assessed by the Investigator.
Group
Value
95% CI
Phase 2: Enrolled at Lenalidomide Dose 20 mg
32.1
Phase 2: Enrolled at Lenalidomide Dose 25 mg
21.9
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
28.2
Phase 2: Duration of Response (DOR)Secondary· Estimated median time on study in Phase 2 was 35.0 months.
DOR is defined as the time from the date of the first documented response (CR or PR) to the first documented evidence of disease progression (PD) according to the Revised International Working Group Response Criteria for Malignant Lymphoma or Lugano Classification (Cheson 2014) or death from any cause. For participants who had achieved an overall response but did not die or progress at the time of analysis, DOR was censored on the date of the last adequate post-baseline disease assessment, or on the date of the first occurrence of response (CR or PR) if there was no disease assessment afterwar
Group
Value
95% CI
Phase 2: Enrolled at Lenalidomide Dose 20 mg
38.3
3.7 – NA
Phase 2: Enrolled at Lenalidomide Dose 25 mg
28.6
2.8 – 28.6
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
38.3
9.5 – NA
Phase 2: Progression Free Survival (PFS)Secondary· Estimated median time on study in Phase 2 was 35.0 months.
PFS is defined as the time from the date of the first dose of study drug to confirmed PD according to the Revised International Working Group Response Criteria for Malignant Lymphoma or Lugano Classification (Cheson 2014) or death from any cause, whichever occurred first. For participants without disease progression or death, PFS data was censored at the date of the last tumor assessment. 2 sided 95% CI is estimated by Kaplan-Meier method.
Group
Value
95% CI
Phase 2: Enrolled at Lenalidomide Dose 20 mg
5.4
3.4 – 11.3
Phase 2: Enrolled at Lenalidomide Dose 25 mg
4.7
2.6 – 24.8
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
5.4
3.4 – 6.3
Phase 2: Overall Survival (OS)Secondary· Estimated median time on study in Phase 2 was 35.0 months.
OS is defined as the time from the date of the first dose of study drug to the date of death due to any cause. For participants not known to have died at or prior to the database lock date, OS data was censored at the date last known alive. Participants who withdrew consent prior to study closure were censored on the date of the consent withdrawal. 2-sided 95% CI was estimated by Kaplan-Meier method.
Group
Value
95% CI
Phase 2: Enrolled at Lenalidomide Dose 20 mg
14.7
9.7 – 32.8
Phase 2: Enrolled at Lenalidomide Dose 25 mg
11.6
5.7 – NA
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
14.2
9.7 – 28.1
Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEsSecondary· From first dose of study drug up to 30 days after last dose of study drug. Phase 2 median duration of ibrutinib exposure was 4.9 months; median duration of lenalidomide exposure was 4.7 months; median total number of doses of rituximab received was 5.0.
An adverse event (AE) is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious AE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization \> 24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. AEs that started or worsened during the treatment-emergent period and all possibly related or related AEs were considered TEAEs. Related events w
Any TEAE
Group
Value
95% CI
Phase 2: Enrolled at Lenalidomide Dose 20 mg
55
Phase 2: Enrolled at Lenalidomide Dose 25 mg
34
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
89
Any Grade >=3 TEAE
Group
Value
95% CI
Phase 2: Enrolled at Lenalidomide Dose 20 mg
51
Phase 2: Enrolled at Lenalidomide Dose 25 mg
30
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
81
Any Study Drug-Related TEAE
Group
Value
95% CI
Phase 2: Enrolled at Lenalidomide Dose 20 mg
52
Phase 2: Enrolled at Lenalidomide Dose 25 mg
33
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
85
Any Grade >=3 Study Drug-Related TEAE
Group
Value
95% CI
Phase 2: Enrolled at Lenalidomide Dose 20 mg
41
Phase 2: Enrolled at Lenalidomide Dose 25 mg
25
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
66
Any Ibrutinib-Related TEAE
Group
Value
95% CI
Phase 2: Enrolled at Lenalidomide Dose 20 mg
50
Phase 2: Enrolled at Lenalidomide Dose 25 mg
32
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
82
Any Grade >=3 Ibrutinib-Related TEAE
Group
Value
95% CI
Phase 2: Enrolled at Lenalidomide Dose 20 mg
36
Phase 2: Enrolled at Lenalidomide Dose 25 mg
24
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
60
Any Lenalidomide-Related TEAE
Group
Value
95% CI
Phase 2: Enrolled at Lenalidomide Dose 20 mg
51
Phase 2: Enrolled at Lenalidomide Dose 25 mg
32
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
83
Any Grade >=3 Lenalidomide-Related TEAE
Group
Value
95% CI
Phase 2: Enrolled at Lenalidomide Dose 20 mg
40
Phase 2: Enrolled at Lenalidomide Dose 25 mg
25
Phase 2 Total: Enrolled at Lenalidomide Dose 20 or 25 mg
65
Adverse events — posted to ClinicalTrials.gov
Time frame: All Cause Mortality Time Frame: Estimated median time on study in Phase 1b was 59.6 months. Estimated median time on study in Phase 2 was 35.0 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not eligible for transplant.
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 Relapsed Diffuse Large B-Cell Lymphoma
Currently open trials in the same condition.
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· Phase 1, PHASE2
· active not recruiting
NCT04384484 — Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refra
· Phase 3
· active not recruiting
Other Pharmacyclics LLC. trials
Trials by the same sponsor.
NCT03790332 — Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD
· Phase 1, PHASE2
· completed
NCT03112174 — Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL)
· Phase 3
· completed
NCT02959944 — Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New On
· Phase 3
· completed
NCT02947347 — Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
· Phase 3
· completed
NCT02910583 — Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL
· Phase 2
· completed
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 Pharmacyclics LLC.
Last refreshed: 4 February 2022
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/NCT02077166.