Trial · NCT01614821

Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia

NCT01614821, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2020-01-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia. Trials, record NCT01614821. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01614821

On this page

Trial

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

Title: Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia
NCT number: NCT01614821
Status: Completed
Phases: Phase 2
Enrollment: 63 participants, actual
Lead sponsor: Dana-Farber Cancer Institute
Conditions: Waldenstrom's Macroglobulinemia
Interventions: PCI-32765
First posted: 2012-06-08
Last updated: 2020-01-21
Results first posted: 2020-01-21

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Overall Response Rate	4 years	To assess the overall response rate (\>25% reduction in serum IgM from baseline).
Secondary	Safety and Tolerability of PCI-32765	4 years	To assess the safety and tolerability of PCI-32765 in symptomatic WM patients with relapsed/refractory disease. Grade \> or = 2 Adverse Events determined to be associated with PCI-32765 and subsequent outcomes will constitute the safety profile of PCI-32765 in WM. Percent of participants who experienced at least 1 grade 2 or higher treatment emergent adverse event.
Secondary	Determine Progression Free Survival	6 years	To determine Progression Free Survival (PFS in symptomatic WM patients with relapsed/refractory disease. Participants were treated for 40 cycles and then followed for 2 years or until next therapy or death. 40 participants were censored prior to disease progression.
Secondary	To Determine Time to Next Therapy (TTNT) of PCI-32765 in Symptomatic WM Patients With Relapsed/Refractory Disease	6 years	Time to Next Therapy is the duration of time from of starting ibrutinib until next therapy. Participants were treated for 40 cycles and then followed for 2 years or until next therapy or death. Participants had the option to continue ibrutinib commercially. 40 participants were censored while still on commercial ibrutinib therapy.
Secondary	Major Response Rates	4 years	To assess the major response rate (\>50% reduction in serum IgM from baseline)
Secondary	Very Good Partial Response Rate	4 years	To assess the very good partial response rate (\>90% reduction in serum IgM from baseline)

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Overall Response Rate	4 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Safety and Tolerability of PCI-32765	4 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Determine Progression Free Survival	6 years	months	MEDIAN
SECONDARY	To Determine Time to Next Therapy (TTNT) of PCI-32765 in Symptomatic WM Patients With Relapsed/Refractory Disease	6 years	months	MEDIAN
SECONDARY	Major Response Rates	4 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Very Good Partial Response Rate	4 years	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Overall Response Rate	Treatment Arm	57		Participants
Safety and Tolerability of PCI-32765	Treatment Arm	62		Participants
Determine Progression Free Survival	Treatment Arm	39	Full Range 0 to 67	months
To Determine Time to Next Therapy (TTNT) of PCI-32765 in Symptomatic WM Patients With Relapsed/Refractory Disease	Treatment Arm	49	Full Range 1 to 67	months
Major Response Rates	Treatment Arm	49		Participants
Very Good Partial Response Rate	Treatment Arm	17		Participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment Arm	63
Overall Study	COMPLETED	Treatment Arm	63
Overall Study	NOT COMPLETED	Treatment Arm	0

Source ClinicalTrials.gov

Adverse events174

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	Abdominal Pain	Gastrointestinal disorders	Treatment Arm	7	63	7
other	Acute kidney injury	Renal and urinary disorders	Treatment Arm	1	63	1
other	Alanine aminotransferase increased	Investigations	Treatment Arm	2	63	2
other	Alkaline phosphatase increased	Investigations	Treatment Arm	2	63	2
other	Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Treatment Arm	1	63	1
other	Alopecia	Skin and subcutaneous tissue disorders	Treatment Arm	1	63	1
other	Anemia	Blood and lymphatic system disorders	Treatment Arm	40	63	40
other	Anorexia	Metabolism and nutrition disorders	Treatment Arm	2	63	2
other	Anxiety	Psychiatric disorders	Treatment Arm	6	63	6
other	Arthralgia	Musculoskeletal and connective tissue disorders	Treatment Arm	17	63	17

1 to 10 of 174Source ClinicalTrials.gov

See all 174 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment Arm	1	63
Total, other adverse events	Treatment Arm	62	63
Total, serious adverse events	Treatment Arm	30	63

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25853747	DERIVED	PubMed
32931398	DERIVED	PubMed
40674744	DERIVED	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 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.

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/NCT01614821

GET https://conductscience.org/api/trials/v1/NCT01614821/events?page=2

API reference For AI assistants