Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia



Status:Active, not recruiting
Conditions:Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:July 2014
End Date:December 2019

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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

The purpose of this study is to evaluate the safety and efficacy of Ibrutinib in combination
with Rituximab in subjects with Waldenström's Macroglobulinemia.


Eligibility Criteria for the Randomized Study (Arm A and Arm B)

Inclusion Criteria:

- Untreated or previously treated for Waldenström's macroglobulinemia. 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 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 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 IgE-mediated hypersensitivity to murine proteins or to any
component of rituximab.

- Prior exposure to ibrutinib or other 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.
We found this trial at
10
sites
Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, GA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Chicago, IL
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
720-754-4800
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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Denver, CO
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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New York, New York 10065
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New York, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Palo Alto, California 94304
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Palo Alto, CA
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