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Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia

Primary Purpose

Waldenström's Macroglobulinemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ibrutinib
Placebo
Rituximab
Sponsored by
Pharmacyclics LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Waldenström's Macroglobulinemia focused on measuring Ibrutinib, Pharmacyclics, PCYC, Lymphoma, Btk inhibitor, WM, Rituximab, Rituxan, Waldenström's, Waldenstrom Macroglobulinemia, non-Hodgkin lymphoma, NHL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Eligibility Criteria for the Randomized Study

Inclusion Criteria:

  • Untreated or previously treated for WM. Previously treated subjects must have either documented disease progression or had no response (stable disease) to the most recent treatment regimen
  • Centrally confirmed clinicopathological diagnosis of WM
  • Measurable disease defined as serum monoclonal immunoglobulin M (IgM) >0.5 g/dL
  • Symptomatic disease meeting at least 1 of the recommendations from the Second International Workshop on Waldenström Macroglobulinemia for requiring treatment
  • Hematology and biochemical values within protocol-defined limits
  • Men and women ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Exclusion Criteria:

  • Known involvement of the central nervous system by WM

  • Disease that is refractory to the last prior rituximab-containing therapy defined as either

    • Relapse after the last rituximab-containing therapy < 12 months since last dose of rituximab, OR
    • Failure to achieve at least a minor response (MR) after the last rituximab-containing therapy If the subject meets this exclusion criterion and therefore is excluded from the main randomized study, participation in the non randomized substudy (Arm C) may be considered
  • Rituximab treatment within the last 12 months before the first dose of study drug
  • Known anaphylaxis or (immunoglobulin E) IgE-mediated hypersensitivity to murine proteins or to any component of rituximab
  • Prior exposure to ibrutinib or other Bruton's tyrosine kinase (BTK) inhibitors
  • Known bleeding disorders (eg, von Willebrand's disease) or hemophilia
  • History of stroke or intracranial hemorrhage within 12 months prior to enrollment.
  • Any uncontrolled active systemic infection.
  • Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
  • Currently active, clinically significant cardiovascular disease
  • Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor

Eligibility Criteria for Open-label Substudy Treatment Arm C

The inclusion/exclusion criteria for the substudy (Arm C) are identical to those described above for the randomized study but, to be eligible, subjects need to be considered refractory to the last prior rituximab-containing therapy defined as either

  • Relapse after the last rituximab-containing therapy <12 months since last dose of rituximab, OR
  • Failure to achieve at least a MR after the last rituximab-containing therapy.

Sites / Locations

  • University of California Los Angeles
  • Stanford Cancer Center
  • Colorado Blood Cancer Institute
  • Emory University Hospital
  • Northwestern Memorial Hospital
  • Dana Farber Cancer Institute
  • Hackensack University Medical Center
  • Memorial Sloan Kettering Cancer Center
  • Weill Cornell Medical Center
  • Vanderbilt University Medical Center
  • The Canberra Hospital
  • Concord Repartriation General Hospital
  • Flinders Medical Center
  • Peter MacCallum Cancer Center
  • Cross Cancer Institute
  • Queen Elizabeth II Health Sciences Center
  • Princess Margaret Hospital
  • McGill University Health Center
  • Institut Paoli-Calmettes
  • Centre Hospitalier de Saint Brieuc Hopital Yves le Foll
  • Hôtel Dieu
  • CHU de Nancy-Hopital Brabois Adulte
  • Hôpital Claude Huriez
  • CHU Estaing
  • Centre Hospitalier Lyon Sud
  • Hopital Henri Mondor
  • Hôpital Saint Louis
  • Groupe Hospitalier Pitié Salpétrière
  • Stauferklinikum Schwäbisch Gmünd
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Universität Des Saarlandes
  • DIAKO Evangelische Diakonie Krankenhaus gGmbH
  • LMU Klinikum der Universität München
  • University General Hospital of Patras
  • Alexandra Hospital
  • University General Hospital of Thessaloniki "AHEPA"
  • Laiko General Hospital of Athens
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
  • ASST Grande Ospedale Metropolitano Niguarda
  • ASST di Pavia - Fondazione IRCCS Policlinico San Matteo di Pavia
  • Azienda Ospedaliero Universitaria Santa Maria della Misericordia di Udine
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Universitario de Salamanca
  • Hospital Clinic de Barcelona
  • Hospital de La Santa Creu i Sant Pau
  • Hospital Universitario Infanta Leonor
  • Royal Bournemouth Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Randomized Study (Ibrutinib + Rituximab)

Randomized Study (Placebo + Rituximab)

Open-Label Substudy (Ibrutinib)

Arm Description

Ibrutinib: 420 mg (3 capsules x 140 mg) orally administered daily beginning from Day 1. Rituximab: 375 mg/m^2 intravenous (IV) per package insert weekly for four consecutive weeks, followed by a second four-weekly rituximab course after a three-month interval.

Placebo: 3 capsules of placebo orally administered daily beginning from Day 1. Rituximab: 375 mg/m^2 IV per package insert weekly for four consecutive weeks, followed by a second four-weekly rituximab course after a three-month interval.

Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 54
PFS was defined as the time from date randomization to date of first IRC-confirmed disease progression (PD) assessed according to the modified VIth International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria (National Comprehensive Cancer Network [NCCN] 2014) or death due to any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death. As the median PFS was not reached in the Ibrutinib + Rituximab arm at the time of the analysis, Kaplan Meier landmark estimate of the PFS rate at 54 months (that is, the estimated percentage of participants with PFS at Month 54) is presented.

Secondary Outcome Measures

Overall Response Rate (ORR) Based on IRC Assessment Up to 3 Years After Last Participant Randomized
ORR, defined as the percentage of participants achieving a best overall response of protocol-specified complete response (CR), very good partial response (VGPR), or partial response (PR) per the IRC assessment at or prior to initiation of subsequent antineoplastic therapy and confirmed by 2 consecutive assessments. IRC assessment of response was conducted according to the modified VIth IWWM (NCCN 2014) criteria and incorporated assessments from the central radiology review. CR required complete resolution of lymphadenopathy/splenomegaly if present at baseline. VGPR and PR required reduction in lymphadenopathy/splenomegaly if present at baseline.. Kaplan-Meier estimate.
Time to Next Treatment (TnT) Time From the Date of Randomization to the Start Date of Any Subsequent WM Treatment.
TTnT was measured from the date of randomization to the start date of any subsequent WM treatment. Participants without subsequent treatment were censored at the date of the last study visit. As the median TTnT was not reached in the Ibrutinib + Rituximab arm and the Open-Label Substudy arm at the time of the analysis, Kaplan Meier landmark estimate of the TTnT rate at 54 months (that is, the estimated percentage of participants not receiving subsequent WM treatment at Month 54) are presented.
Percentage of Participants With Sustained Hemoglobin (Hgb) Improvement Up to 3 Years After Last Participant Randomized
Percentage of participants achieving a sustained improvement in Hgb at or prior to initiation of subsequent antineoplastic therapy. Hgb improvement is defined as an increase of ≥ 2 g/dL over baseline regardless of baseline value, or an increase to >11 g/dL with a ≥0.5 g/dL improvement if baseline is ≤ 11 g/dL. Sustained Hgb improvement is defined as improvement that is sustained continuously for ≥ 56 days (8 weeks) without blood transfusion or growth factors, which includes hemoglobin > 110 g/L with at least a 5 g/L improvement if baseline ≤110 g/L or increase ≥20 g/L over baseline.
Percentage of Participants With ≥ 3 Points Increase From Baseline by Week 25 in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Subscale Score
Percentage of participants with ≥ 3 points increase from baseline by Week 25 in the FACIT-Fatigue subscale score.The FACIT-Fatigue is a 13-item questionnaire that assesses participant reported fatigue and its impact upon daily activities and function over the past 7 days. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total scores from 0 (extreme fatigue) to 52 (no fatigue). Scores below 30 indicate severe fatigue.
Overall Survival (OS) - Kaplan Meier Landmark Estimates at Month 54
OS, defined as the time from the date of randomization to the date of death from any cause. All deaths observed as the time of the analysis were considered as events. For participants who were not known to have died at the time of the analysis, OS data were censored at the date last known alive. As the median OS was not reached in any treatment arm at the time of the analysis, Kaplan Meier point estimates of the OS rate (that is, the estimated percentage of participants still surviving at Month 54) are presented.

Full Information

First Posted
June 9, 2014
Last Updated
February 9, 2021
Sponsor
Pharmacyclics LLC.
Collaborators
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02165397
Brief Title
Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia
Official Title
iNNOVATE Study: A Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study of Ibrutinib or Placebo in Combination With Rituximab in Subjects With Waldenström's Macroglobulinemia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 7, 2014 (Actual)
Primary Completion Date
November 7, 2019 (Actual)
Study Completion Date
November 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmacyclics LLC.
Collaborators
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ibrutinib in combination with rituximab in participants with Waldenström's macroglobulinemia (WM).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Waldenström's Macroglobulinemia
Keywords
Ibrutinib, Pharmacyclics, PCYC, Lymphoma, Btk inhibitor, WM, Rituximab, Rituxan, Waldenström's, Waldenstrom Macroglobulinemia, non-Hodgkin lymphoma, NHL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Randomized Study (Ibrutinib + Rituximab)
Arm Type
Experimental
Arm Description
Ibrutinib: 420 mg (3 capsules x 140 mg) orally administered daily beginning from Day 1. Rituximab: 375 mg/m^2 intravenous (IV) per package insert weekly for four consecutive weeks, followed by a second four-weekly rituximab course after a three-month interval.
Arm Title
Randomized Study (Placebo + Rituximab)
Arm Type
Experimental
Arm Description
Placebo: 3 capsules of placebo orally administered daily beginning from Day 1. Rituximab: 375 mg/m^2 IV per package insert weekly for four consecutive weeks, followed by a second four-weekly rituximab course after a three-month interval.
Arm Title
Open-Label Substudy (Ibrutinib)
Arm Type
Experimental
Arm Description
Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1.
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Other Intervention Name(s)
PCI-32765
Intervention Description
Participants will receive 420 mg of Ibrutinib orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo capsules orally.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
Participants will receive rituximab 375 mg/m^2 IV.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 54
Description
PFS was defined as the time from date randomization to date of first IRC-confirmed disease progression (PD) assessed according to the modified VIth International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria (National Comprehensive Cancer Network [NCCN] 2014) or death due to any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death. As the median PFS was not reached in the Ibrutinib + Rituximab arm at the time of the analysis, Kaplan Meier landmark estimate of the PFS rate at 54 months (that is, the estimated percentage of participants with PFS at Month 54) is presented.
Time Frame
Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr])
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR) Based on IRC Assessment Up to 3 Years After Last Participant Randomized
Description
ORR, defined as the percentage of participants achieving a best overall response of protocol-specified complete response (CR), very good partial response (VGPR), or partial response (PR) per the IRC assessment at or prior to initiation of subsequent antineoplastic therapy and confirmed by 2 consecutive assessments. IRC assessment of response was conducted according to the modified VIth IWWM (NCCN 2014) criteria and incorporated assessments from the central radiology review. CR required complete resolution of lymphadenopathy/splenomegaly if present at baseline. VGPR and PR required reduction in lymphadenopathy/splenomegaly if present at baseline.. Kaplan-Meier estimate.
Time Frame
Median time on study: 49.7 months (Ibr+R and Pbo+R) and 57.9 months (Open-Label Ibr)
Title
Time to Next Treatment (TnT) Time From the Date of Randomization to the Start Date of Any Subsequent WM Treatment.
Description
TTnT was measured from the date of randomization to the start date of any subsequent WM treatment. Participants without subsequent treatment were censored at the date of the last study visit. As the median TTnT was not reached in the Ibrutinib + Rituximab arm and the Open-Label Substudy arm at the time of the analysis, Kaplan Meier landmark estimate of the TTnT rate at 54 months (that is, the estimated percentage of participants not receiving subsequent WM treatment at Month 54) are presented.
Time Frame
Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr])
Title
Percentage of Participants With Sustained Hemoglobin (Hgb) Improvement Up to 3 Years After Last Participant Randomized
Description
Percentage of participants achieving a sustained improvement in Hgb at or prior to initiation of subsequent antineoplastic therapy. Hgb improvement is defined as an increase of ≥ 2 g/dL over baseline regardless of baseline value, or an increase to >11 g/dL with a ≥0.5 g/dL improvement if baseline is ≤ 11 g/dL. Sustained Hgb improvement is defined as improvement that is sustained continuously for ≥ 56 days (8 weeks) without blood transfusion or growth factors, which includes hemoglobin > 110 g/L with at least a 5 g/L improvement if baseline ≤110 g/L or increase ≥20 g/L over baseline.
Time Frame
Median time on study: 49.7 months (Ibr+R and Pbo+R) and 57.9 months (Open-Label Ibr)
Title
Percentage of Participants With ≥ 3 Points Increase From Baseline by Week 25 in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Subscale Score
Description
Percentage of participants with ≥ 3 points increase from baseline by Week 25 in the FACIT-Fatigue subscale score.The FACIT-Fatigue is a 13-item questionnaire that assesses participant reported fatigue and its impact upon daily activities and function over the past 7 days. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total scores from 0 (extreme fatigue) to 52 (no fatigue). Scores below 30 indicate severe fatigue.
Time Frame
Baseline, 25 weeks
Title
Overall Survival (OS) - Kaplan Meier Landmark Estimates at Month 54
Description
OS, defined as the time from the date of randomization to the date of death from any cause. All deaths observed as the time of the analysis were considered as events. For participants who were not known to have died at the time of the analysis, OS data were censored at the date last known alive. As the median OS was not reached in any treatment arm at the time of the analysis, Kaplan Meier point estimates of the OS rate (that is, the estimated percentage of participants still surviving at Month 54) are presented.
Time Frame
Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr])

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligibility Criteria for the Randomized Study Inclusion Criteria: Untreated or previously treated for WM. Previously treated subjects must have either documented disease progression or had no response (stable disease) to the most recent treatment regimen Centrally confirmed clinicopathological diagnosis of WM Measurable disease defined as serum monoclonal immunoglobulin M (IgM) >0.5 g/dL Symptomatic disease meeting at least 1 of the recommendations from the Second International Workshop on Waldenström Macroglobulinemia for requiring treatment Hematology and biochemical values within protocol-defined limits Men and women ≥ 18 years of age Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 Exclusion Criteria: Known involvement of the central nervous system by WM Disease that is refractory to the last prior rituximab-containing therapy defined as either Relapse after the last rituximab-containing therapy < 12 months since last dose of rituximab, OR Failure to achieve at least a minor response (MR) after the last rituximab-containing therapy If the subject meets this exclusion criterion and therefore is excluded from the main randomized study, participation in the non randomized substudy (Arm C) may be considered Rituximab treatment within the last 12 months before the first dose of study drug Known anaphylaxis or (immunoglobulin E) IgE-mediated hypersensitivity to murine proteins or to any component of rituximab Prior exposure to ibrutinib or other Bruton's tyrosine kinase (BTK) inhibitors Known bleeding disorders (eg, von Willebrand's disease) or hemophilia History of stroke or intracranial hemorrhage within 12 months prior to enrollment. Any uncontrolled active systemic infection. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk. Currently active, clinically significant cardiovascular disease Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor Eligibility Criteria for Open-label Substudy Treatment Arm C The inclusion/exclusion criteria for the substudy (Arm C) are identical to those described above for the randomized study but, to be eligible, subjects need to be considered refractory to the last prior rituximab-containing therapy defined as either Relapse after the last rituximab-containing therapy <12 months since last dose of rituximab, OR Failure to achieve at least a MR after the last rituximab-containing therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernhard Hauns, MD
Organizational Affiliation
Pharmacyclics LLC (An AbbVie Company)
Official's Role
Study Director
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Stanford Cancer Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Concord Repartriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Flinders Medical Center
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
05042
Country
Australia
Facility Name
Peter MacCallum Cancer Center
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G1Z2
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada
Facility Name
Institut Paoli-Calmettes
City
Marseille
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13273
Country
France
Facility Name
Centre Hospitalier de Saint Brieuc Hopital Yves le Foll
City
Saint-Brieuc
State/Province
Finistère
ZIP/Postal Code
22027
Country
France
Facility Name
Hôtel Dieu
City
Nantes
State/Province
Loire-Atlantique
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Nancy-Hopital Brabois Adulte
City
Vandoeuvre-lès-nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54511
Country
France
Facility Name
Hôpital Claude Huriez
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Estaing
City
Clermont-Ferrand
State/Province
Puy-de-Dôme
ZIP/Postal Code
63000
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-benite
State/Province
Rhône
ZIP/Postal Code
69495
Country
France
Facility Name
Hopital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Groupe Hospitalier Pitié Salpétrière
City
Paris
ZIP/Postal Code
75651 Cedex 13
Country
France
Facility Name
Stauferklinikum Schwäbisch Gmünd
City
Mutlangen
State/Province
Baden-Württemberg
ZIP/Postal Code
73557
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universität Des Saarlandes
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
DIAKO Evangelische Diakonie Krankenhaus gGmbH
City
Bremen
ZIP/Postal Code
28239
Country
Germany
Facility Name
LMU Klinikum der Universität München
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
University General Hospital of Patras
City
Patras
State/Province
Achaia
ZIP/Postal Code
26500
Country
Greece
Facility Name
Alexandra Hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
11528
Country
Greece
Facility Name
University General Hospital of Thessaloniki "AHEPA"
City
Thessaloniki
State/Province
Macedonia
ZIP/Postal Code
54621
Country
Greece
Facility Name
Laiko General Hospital of Athens
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
ASST di Pavia - Fondazione IRCCS Policlinico San Matteo di Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Santa Maria della Misericordia di Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
State/Province
Castilla Y León
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de La Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.
IPD Sharing URL
http://yoda.yale.edu
Citations:
PubMed Identifier
29856685
Citation
Dimopoulos MA, Tedeschi A, Trotman J, Garcia-Sanz R, Macdonald D, Leblond V, Mahe B, Herbaux C, Tam C, Orsucci L, Palomba ML, Matous JV, Shustik C, Kastritis E, Treon SP, Li J, Salman Z, Graef T, Buske C; iNNOVATE Study Group and the European Consortium for Waldenstrom's Macroglobulinemia. Phase 3 Trial of Ibrutinib plus Rituximab in Waldenstrom's Macroglobulinemia. N Engl J Med. 2018 Jun 21;378(25):2399-2410. doi: 10.1056/NEJMoa1802917. Epub 2018 Jun 1.
Results Reference
background
PubMed Identifier
27956157
Citation
Dimopoulos MA, Trotman J, Tedeschi A, Matous JV, Macdonald D, Tam C, Tournilhac O, Ma S, Oriol A, Heffner LT, Shustik C, Garcia-Sanz R, Cornell RF, de Larrea CF, Castillo JJ, Granell M, Kyrtsonis MC, Leblond V, Symeonidis A, Kastritis E, Singh P, Li J, Graef T, Bilotti E, Treon S, Buske C; iNNOVATE Study Group and the European Consortium for Waldenstrom's Macroglobulinemia. Ibrutinib for patients with rituximab-refractory Waldenstrom's macroglobulinaemia (iNNOVATE): an open-label substudy of an international, multicentre, phase 3 trial. Lancet Oncol. 2017 Feb;18(2):241-250. doi: 10.1016/S1470-2045(16)30632-5. Epub 2016 Dec 10.
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Buske C, Tedeschi A, Trotman J, Garcia-Sanz R, MacDonald D, Leblond V, Mahe B, Herbaux C, Matous JV, Tam CS, Heffner LT, Varettoni M, Palomba ML, Shustik C, Kastritis E, Treon SP, Ping J, Hauns B, Arango-Hisijara I, Dimopoulos MA. Ibrutinib Plus Rituximab Versus Placebo Plus Rituximab for Waldenstrom's Macroglobulinemia: Final Analysis From the Randomized Phase III iNNOVATE Study. J Clin Oncol. 2022 Jan 1;40(1):52-62. doi: 10.1200/JCO.21.00838. Epub 2021 Oct 4.
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Trotman J, Buske C, Tedeschi A, Matous JV, MacDonald D, Tam CS, Tournilhac O, Ma S, Treon SP, Oriol A, Ping J, Briso EM, Arango-Hisijara I, Dimopoulos MA. Single-Agent Ibrutinib for Rituximab-Refractory Waldenstrom Macroglobulinemia: Final Analysis of the Substudy of the Phase III InnovateTM Trial. Clin Cancer Res. 2021 Nov 1;27(21):5793-5800. doi: 10.1158/1078-0432.CCR-21-1497. Epub 2021 Aug 11.
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Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia

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