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Trial ยท NCT05564052

A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell Lymphoma

NCT05564052, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2025-01-13

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell Lymphoma. Trials, record NCT05564052. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05564052

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell Lymphoma
NCT number
NCT05564052
Status
Completed
Phases
Phase 2
Enrollment
36 participants, actual
Lead sponsor
Janssen Research & Development, LLC
Conditions
Lymphoma, Mantle-Cell
Interventions
Ibrutinib, Lenalidomide, Rituximab, Bortezomib
First posted
2022-10-03
Last updated
2025-10-07
Other registries' IDs
eudract:2022-000364-21
Results first posted
2025-01-13

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Arms A1, A2, A3 and BFrom start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as any new or worsening AE occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. All TEAEs including serious and non-serious events were reported in this outcome measure.
PrimaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Monotherapy Arm
From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as any new or worsening AE occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. All TEAEs included serious and non-serious events were reported in this outcome measure.
PrimaryNumber of Participants With Grade 3 or Higher TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0: Arms A1, A2, A3 and BFrom start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as any new or worsening AE occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. TEAEs were graded according to NCI-CTCAE v5.0 as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences and Grade 5- Death related to AE. Number of participants with grade 3 or higher TEAEs (including serious and non-serious events) were reported in this outcome measure.
PrimaryNumber of Participants With Grade 3 or Higher TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0: Monotherapy Arm
From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as any new or worsening AE occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. TEAEs were graded according to NCI-CTCAE v5.0 as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences and Grade 5- Death related to AE. Number of participants with grade 3 or higher TEAEs (including serious and non-serious events) were reported in this outcome measure.
PrimaryNumber of Participants With Treatment Emergent Serious Adverse Events (TESAEs): Arms A1, A2, A3 and BFrom start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious AE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, or was medically important. TESAEs was defined as SAEs occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first.
PrimaryNumber of Participants With Treatment Emergent Serious Adverse Events (TESAEs): Monotherapy Arm
From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious AE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, or was medically important. TESAEs was defined as SAEs occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first.
PrimaryNumber of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and BFrom start of treatment (Day 1) up to 30 days after last dose of study drug (up to 12 months)
Number of participants with clinical abnormalities in hematology laboratory parameters were reported. Hematology parameters included: Activated partial thromboplastin time (aPTT), hemoglobin, neutrophil count, white blood cell (WBC) count, lymphocyte count, platelet count and prothrombin international normalized ratio (INR). Abnormality criteria was assessed as per NCI CTCAE v5.0 grading, where Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening. Grade 0 was assigned when the laboratory value was not assigned a Grade 1 or higher. Only those categories in which at least 1 participant had data were reported.
PrimaryNumber of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy ArmFrom start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug (up to 6 months)
Number of participants with clinical abnormalities in hematology laboratory parameters were reported. Hematology parameters included: Activated partial thromboplastin time (aPTT), hemoglobin, neutrophil count, white blood cell (WBC) count, lymphocyte count, platelet count and prothrombin international normalized ratio (INR). Abnormality criteria was assessed as per NCI CTCAE v5.0 grading, where Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening. Grade 0 was assigned when the laboratory value was not assigned a Grade 1 or higher. Only those categories in which at least 1 participant had data were reported.
PrimaryNumber of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and BFrom start of treatment (Day 1) up to 30 days after last dose of study drug (up to 12 months)
Number of participants with clinical abnormalities in chemistry laboratory parameters were reported. Chemistry parameters included: sodium, aspartate aminotransferase (AST), potassium, alanine aminotransferase (ALT), creatinine, total bilirubin (BL), alkaline phosphatase, albumin, and calcium. Abnormality criteria was assessed as per NCI CTCAE v5.0 grading, where Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening. Grade 0 was assigned when the laboratory value was not assigned a Grade 1 or higher. Only those categories in which at least 1 participant had data were reported.
PrimaryNumber of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy ArmFrom start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug (up to 6 months)
Number of participants with clinical abnormalities in chemistry laboratory parameters were reported. Chemistry parameters included: sodium, aspartate aminotransferase (AST), potassium, alanine aminotransferase (ALT), creatinine, total bilirubin, alkaline phosphatase, albumin, and calcium. Abnormality criteria was assessed as per NCI CTCAE v5.0 grading, where Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening. Grade 0 was assigned when the laboratory value was not assigned a Grade 1 or higher. Only those categories in which at least 1 participant had data were reported.

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Arms A1, A2, A3 and BFrom start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months)Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Monotherapy Arm
From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Grade 3 or Higher TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0: Arms A1, A2, A3 and BFrom start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months)Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Grade 3 or Higher TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0: Monotherapy Arm
From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Treatment Emergent Serious Adverse Events (TESAEs): Arms A1, A2, A3 and BFrom start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months)Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Treatment Emergent Serious Adverse Events (TESAEs): Monotherapy Arm
From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and BFrom start of treatment (Day 1) up to 30 days after last dose of study drug (up to 12 months)
Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Here, 'n' (number analyzed) signifies the participants analyzed for each specified parameter and n=0 signifies that there was no evaluable participant for specified parameter.
ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy ArmFrom start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug (up to 6 months)
Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) refers to number of participants analyzed for each specified parameter.
ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and BFrom start of treatment (Day 1) up to 30 days after last dose of study drug (up to 12 months)Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy ArmFrom start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug (up to 6 months)
Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) refers to number of participants analyzed for each specified parameter.
ParticipantsCOUNT_OF_PARTICIPANTS

Results by group305

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Arms A1, A2, A3 and BArm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2Discontinuation of Treatment Ibrutinib/Lenalidomide1Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Arms A1, A2, A3 and BArm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2Discontinuation of Treatment Ibrutinib/Lenalidomide0Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Arms A1, A2, A3 and BArm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2Discontinuation of Treatment Ibrutinib/Lenalidomide0Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Arms A1, A2, A3 and BArm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2Discontinuation of Treatment Ibrutinib/Lenalidomide2Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Arms A1, A2, A3 and BArm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2Discontinuation of Treatment Rituximab0Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Arms A1, A2, A3 and BArm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2Discontinuation of Treatment Rituximab1Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Arms A1, A2, A3 and BArm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2Discontinuation of Treatment Rituximab0Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Arms A1, A2, A3 and BArm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2Discontinuation of Treatment Rituximab1Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Monotherapy ArmMonotherapy Arm: Ibrutinib 560 mg1Participants
Number of Participants With Grade 3 or Higher TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0: Arms A1, A2, A3 and BArm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^27Participants

Participant flow16

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDArm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^210
Overall StudySTARTEDArm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^29
Overall StudySTARTEDArm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^28
Overall StudySTARTEDArm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^29
Overall StudyParticipants Who Switched to Ibrutinib MonotherapyArm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^20
Overall StudyParticipants Who Switched to Ibrutinib MonotherapyArm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^24
Overall StudyParticipants Who Switched to Ibrutinib MonotherapyArm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^23
Overall StudyParticipants Who Switched to Ibrutinib MonotherapyArm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^22
Overall StudyCOMPLETEDArm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^210
Overall StudyCOMPLETEDArm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^29

Adverse events575

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAnaemiaBlood and lymphatic system disordersArm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2110
otherAnaemiaBlood and lymphatic system disordersArm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^209
otherAnaemiaBlood and lymphatic system disordersArm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^218
otherAnaemiaBlood and lymphatic system disordersArm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^239
otherAnaemiaBlood and lymphatic system disordersMonotherapy Arm: Ibrutinib 560 mg09
otherEosinophiliaBlood and lymphatic system disordersArm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2010
otherEosinophiliaBlood and lymphatic system disordersArm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^209
otherEosinophiliaBlood and lymphatic system disordersArm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^218
otherEosinophiliaBlood and lymphatic system disordersArm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^219
otherEosinophiliaBlood and lymphatic system disordersMonotherapy Arm: Ibrutinib 560 mg09

Adverse event totals15

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityArm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2110
Total, all-cause mortalityArm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^209
Total, all-cause mortalityArm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^218
Total, all-cause mortalityArm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^229
Total, all-cause mortalityMonotherapy Arm: Ibrutinib 560 mg09
Total, other adverse eventsArm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^21010
Total, other adverse eventsArm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^279
Total, other adverse eventsArm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^288
Total, other adverse eventsArm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^289
Total, other adverse eventsMonotherapy Arm: Ibrutinib 560 mg49

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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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