Trial · NCT02947347

Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

NCT02947347, Phase 3, Completed, Pharmacyclics LLC.; results first posted 2026-03-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma. Trials, record NCT02947347. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02947347

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Trial

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

Title: Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
NCT number: NCT02947347
Status: Completed
Phases: Phase 3
Enrollment: 445 participants, actual
Lead sponsor: Pharmacyclics LLC.
Conditions: Follicular Lymphoma
Interventions: Ibrutinib Oral Capsule, Placebo, Rituximab
First posted: 2016-10-27
Last updated: 2026-03-17
Other registries' IDs: eudract:2016-003202-14
Results first posted: 2026-03-17

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Progression-Free Survival (PFS) as Assessed by Investigator	Primary Analysis cut-off; median overall follow-up of 53.75 months	PFS is the time from the date of randomization to the date of the first documented evidence of disease progression (based on the Revised Response Criteria for Malignant Lymphoma \[Cheson 2014, Lugano Classification\]) or death from any cause, whichever occurs first. Participants who initiated subsequent anticancer therapy or missed two or more consecutive overall disease assessments were censored as described in the SAP. Estimated by Kaplan-Meier method.
Secondary	Overall Response Rate (ORR) as Assessed by Investigator	Primary Analysis; median overall follow-up of 53.75 months	ORR is the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR) as determined by the investigator according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014, Lugano Classification). ORR was assessed from the date of randomization through the date of first documented disease progression or initiation of subsequent anti-cancer therapy, whichever occurred first. Participants who did not have any post-baseline disease assessments or who initiated subsequent anti-cancer therapy prior to a documented response are considered non-responders.
Secondary	Overall Survival (OS)	Final Analysis; median overall follow-up of 58.97 months	Overall survival is defined as the interval between the date of randomization and the date of the participant's death from any cause. If a participant is not known to have died (this includes participants with unknown death date), OS will be censored at the date the participant was last known to have been alive. Estimated by Kaplan-Meier method.
Secondary	Infusion-related Reaction Rate Assessed by Investigator	Primary Analysis; median overall follow-up of 53.75 months	The infusion-related reactions (IRR) rate is the proportion of subjects experiencing infusion related reactions that start on the day of a rituximab infusion and are assessed as related or possibly related to rituximab.
Secondary	Duration of Response (DOR) as Assessed by Investigator	Primary Analysis; median overall follow-up of 53.75 months	DOR is defined as the time from initial complete response (CR) or partial response (PR) to progressive disease (PD) or death due to any cause, whichever is first reported, regardless of discontinuation of study treatment. If such event did not occur, then participants were to be censored at the last adequate disease assessment as required for PFS censoring. Estimated by Kaplan-Meier method.
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Overall median treatment duration of 22.11 months	An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The treatment-emergent period is defined as the period from the date of the first dose of study treatment up to 30 days after the date of the last dose of study treatment or the day before initiation of subsequent anti-cancer therapy, whichever comes first. The treatment-emergent adverse events (TEAEs) are those events that occur or worsen during the treatment-emergent period or that are related to the study treatment.

Source ClinicalTrials.gov

Outcomes6

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) as Assessed by Investigator	Primary Analysis cut-off; median overall follow-up of 53.75 months	ITT Population. Participants achieving response (partial response or better) who initiated subsequent anticancer therapy or missed two or more consecutive overall disease assessments were censored.	months	MEDIAN
SECONDARY	Overall Response Rate (ORR) as Assessed by Investigator	Primary Analysis; median overall follow-up of 53.75 months	ITT population	percentage of participants	NUMBER
SECONDARY	Overall Survival (OS)	Final Analysis; median overall follow-up of 58.97 months	ITT Population	months	MEDIAN
SECONDARY	Infusion-related Reaction Rate Assessed by Investigator	Primary Analysis; median overall follow-up of 53.75 months	ITT Population	percentage of participants	NUMBER
SECONDARY	Duration of Response (DOR) as Assessed by Investigator	Primary Analysis; median overall follow-up of 53.75 months	ITT Population. Participants achieving a response (partial response or better) are included in this analysis. Participants achieving response (partial response or better) who initiated subsequent anticancer therapy or missed two or more consecutive overall disease assessments were censored.	months	MEDIAN
SECONDARY	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Overall median treatment duration of 22.11 months	Safety Population	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group22

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

Outcome	Group	Value	Spread	Units
Progression-Free Survival (PFS) as Assessed by Investigator	Arm A: Ibrutinib + Rituximab	42.02	95% Confidence Interval 33.31 to 50.83	months
Progression-Free Survival (PFS) as Assessed by Investigator	Arm B: Placebo + Rituximab	32.76	95% Confidence Interval 22.05 to 38.67	months
Overall Response Rate (ORR) as Assessed by Investigator	Arm A: Ibrutinib + Rituximab	81.4	95% Confidence Interval 76.8 to 85.5	percentage of participants
Overall Response Rate (ORR) as Assessed by Investigator	Arm B: Placebo + Rituximab	68.5	95% Confidence Interval 59.0 to 77.0	percentage of participants
Overall Survival (OS)	Arm A: Ibrutinib + Rituximab	NA	95% Confidence Interval 69.72 to NA	months
Overall Survival (OS)	Arm B: Placebo + Rituximab	78.98	95% Confidence Interval 57.36 to NA	months
Infusion-related Reaction Rate Assessed by Investigator	Arm A: Ibrutinib + Rituximab	21.3	95% Confidence Interval 17.0 to 26.0	percentage of participants
Infusion-related Reaction Rate Assessed by Investigator	Arm B: Placebo + Rituximab	27.0	95% Confidence Interval 19.0 to 36.3	percentage of participants
Duration of Response (DOR) as Assessed by Investigator	Arm A: Ibrutinib + Rituximab	44.25	95% Confidence Interval 36.63 to NA	months
Duration of Response (DOR) as Assessed by Investigator	Arm B: Placebo + Rituximab	34.56	95% Confidence Interval 29.21 to 47.31	months

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow10

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A: Ibrutinib + Rituximab	334
Overall Study	STARTED	Arm B: Placebo + Rituximab	111
Overall Study	On Study Treatment at Study Closure	Arm A: Ibrutinib + Rituximab	50
Overall Study	On Study Treatment at Study Closure	Arm B: Placebo + Rituximab	22
Overall Study	Off Treatment and on Follow-up at Study Closure	Arm A: Ibrutinib + Rituximab	108
Overall Study	Off Treatment and on Follow-up at Study Closure	Arm B: Placebo + Rituximab	33
Overall Study	COMPLETED	Arm A: Ibrutinib + Rituximab	158
Overall Study	COMPLETED	Arm B: Placebo + Rituximab	55
Overall Study	NOT COMPLETED	Arm A: Ibrutinib + Rituximab	176
Overall Study	NOT COMPLETED	Arm B: Placebo + Rituximab	56

Source ClinicalTrials.gov

Adverse events682

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	Arm A: Ibrutinib + Rituximab	49	334	83
other	ANAEMIA	Blood and lymphatic system disorders	Arm B: Placebo + Rituximab	9	111	13
other	INCREASED TENDENCY TO BRUISE	Blood and lymphatic system disorders	Arm A: Ibrutinib + Rituximab	31	334	40
other	INCREASED TENDENCY TO BRUISE	Blood and lymphatic system disorders	Arm B: Placebo + Rituximab	0	111	0
other	NEUTROPENIA	Blood and lymphatic system disorders	Arm A: Ibrutinib + Rituximab	67	334	118
other	NEUTROPENIA	Blood and lymphatic system disorders	Arm B: Placebo + Rituximab	12	111	15
other	THROMBOCYTOPENIA	Blood and lymphatic system disorders	Arm A: Ibrutinib + Rituximab	31	334	72
other	THROMBOCYTOPENIA	Blood and lymphatic system disorders	Arm B: Placebo + Rituximab	1	111	1
other	ATRIAL FIBRILLATION	Cardiac disorders	Arm A: Ibrutinib + Rituximab	36	334	39
other	ATRIAL FIBRILLATION	Cardiac disorders	Arm B: Placebo + Rituximab	1	111	1

1 to 10 of 682Source ClinicalTrials.gov

See all 682 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A: Ibrutinib + Rituximab	123	334
Total, all-cause mortality	Arm B: Placebo + Rituximab	40	111
Total, other adverse events	Arm A: Ibrutinib + Rituximab	310	334
Total, other adverse events	Arm B: Placebo + Rituximab	101	111
Total, serious adverse events	Arm A: Ibrutinib + Rituximab	214	334
Total, serious adverse events	Arm B: Placebo + Rituximab	48	111

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42317205	DERIVED

Source PubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm A: Ibrutinib + Rituximab vs Arm B: Placebo + Rituximab: deaths from any cause	Trial comparisons
Arm A: Ibrutinib + Rituximab vs Arm B: Placebo + Rituximab: 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.

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.

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/NCT02947347

GET https://conductscience.org/api/trials/v1/NCT02947347/results?page=2

API reference For AI assistants