Phase
Condition
Mantle Cell Lymphoma
Waldenstrom Macroglobulinemia
Lymphoma
Treatment
Zanubrutinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Participants must meet protocol defined disease criteria requiring treatment fortheir respective disease prior to initiation of ibrutinib or acalabrutinib
Ibrutinib and acalabrutinib intolerance is defined as an unacceptable toxicitywhere, in the opinion of the investigator, treatment should be discontinued in spiteof optimal supportive care as a result of one of the following:
For ibrutinib and acalabrutinib intolerance events:
- 1 or more ≥ Grade 2 nonhematologic toxicities for >7 days (with or withouttreatment)
- 1 or more ≥ Grade 3 nonhematologic toxicity of any duration
- 1 or more Grade 3 neutropenia with infection or fever of any duration; or
- Grade 4 heme toxicity which persists to the point that the investigatorchose to stop therapy due to toxicity NOT progression.
- For acalabrutinib intolerance events only;
- 1 or more ≥ Grade 1 nonhematologic toxicities of any duration with > 3recurrent episodes; or
- 1 or more ≥ Grade 1 nonhematologic toxicities for > 7 days (with orwithout treatment); or
- Inability to use acid-reducing agents or anticoagulants (eg, proton pumpinhibitors, warfarin) due to concurrent acalabrutinib use
Ibrutinib and/or acalabrutinib-related ≥ Grade 2 toxicities must have resolved to ≤Grade 1 or baseline prior to initiating treatment with zanubrutinib. Grade 1acalabrutinib-related toxicities must have resolved to Grade 0 or baseline prior toinitiating treatment with zanubrutinib.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Absolute neutrophil count (ANC) ≥ 1000/mm^3 with or without growth factor supportand platelet count ≥ 50,000/mm^3 (may be post-transfusion), on or prior to C1D1 ofzanubrutinib
Exclusion
Key Exclusion Criteria:
Clinically significant cardiovascular disease including the following:
Myocardial infarction within 6 months before the Screening
Unstable angina within 3 months before the Screening
New York Heart Association class III or IV congestive heart failure
History of sustained ventricular tachycardia, ventricular fibrillation, and/orTorsades de Pointes
QT interval corrected by Fridericia's formula > 480 milliseconds
History of Mobitz II second-degree or third-degree heart block without apermanent pacemaker in place
History of central nervous system (CNS) hemorrhage
Documented progressive disease (PD) during ibrutinib and/or acalabrutinib treatment.
Have received any anticancer therapy (other than immunotherapy) for CLL/SLL, WM,MCL, and MZL < 7 days before any Screening assessments are performed or anyimmunotherapy treatment, taken alone or as part of a chemoimmunotherapy regimen, < 4weeks before any Screening assessments are performed
Requires ongoing need for corticosteroid treatment > 10 mg daily of prednisone orequivalent corticosteroid. Note: Systemic corticosteroids must be fully taperedoff/discontinued ≥ 5 days before the first dose of study drug is administered.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Cci Clearview Cancer Insitute
Huntsville, Alabama 35805
United StatesSite Not Available
Oncology Specialties, PC
Huntsville, Alabama 35805
United StatesSite Not Available
Arizona Oncology Associates - Tucson - Rudasill Road
Tucson, Arizona 85704
United StatesActive - Recruiting
Arizona Oncology Associates, Pc Hope
Tucson, Arizona 85711
United StatesSite Not Available
Innovative Clinical Research Institute
Whittier, California 90603
United StatesSite Not Available
Rocky Mountain Cancer Centers
Aurora, Colorado 80012
United StatesSite Not Available
Rocky Mountain Cancer Centers (Williams) Usor
Aurora, Colorado 80012-5405
United StatesSite Not Available
Rocky Mountain Cancer Centers
Lone Tree, Colorado 80124
United StatesSite Not Available
Christiana Care
Newark, Delaware 19713-2055
United StatesSite Not Available
Medical Oncology Hematology Consultants, PA
Newark, Delaware 19713
United StatesActive - Recruiting
SCRI Florida Cancer Specialists South
Fort Myers, Florida 33901
United StatesActive - Recruiting
Scri Florida Cancer Specialists South
Fort Myers, Florida 33901-8108
United StatesSite Not Available
21st Century Oncology of Jacksonville - Medical Oncology Division
Jacksonville, Florida 32256
United StatesActive - Recruiting
St Century Oncology
Jacksonville, Florida 32204-1128
United StatesSite Not Available
Florida Cancer Specialsts - Largo
Largo, Florida 33770
United StatesSite Not Available
Mid Florida Hematology and Oncology Center
Orange City, Florida 32763-8316
United StatesSite Not Available
Florida Cancer Specialists
Saint Petersburg, Florida 33770
United StatesActive - Recruiting
Scri Florida Cancer Specialists North
Saint Petersburg, Florida 33705-1449
United StatesSite Not Available
Healthcare Research Network
Flossmoor, Illinois 60472
United StatesSite Not Available
Healthcare Research Network Iii, Llc
Flossmoor, Illinois 60422-2067
United StatesSite Not Available
Healthcare Research Network
Tinley Park, Illinois 60487
United StatesSite Not Available
Healthcare Research Network Iii, Llc
Tinley Park, Illinois 60487
United StatesSite Not Available
Minnesota Oncology Burnsville Clinic
Burnsville, Minnesota 55337-6749
United StatesSite Not Available
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169-3321
United StatesSite Not Available
Comprehensive Cancer Centers of Nevada(CCCN)
Las Vegas, Nevada 89169
United StatesActive - Recruiting
Summit Medical Group
Florham Park, New Jersey 07932-1049
United StatesSite Not Available
Summit Medical Group (SMG) - Florham Park Campus
Florham Park, New Jersey 07932
United StatesActive - Recruiting
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Atlantic Health System/Morristown Medical Center
Morristown, New Jersey 07960
United StatesActive - Recruiting
Morristown Medical Center
Morristown, New Jersey 07960-6136
United StatesSite Not Available
Clinical Research Alliance
New York, New York 10021
United StatesSite Not Available
Manhattan Hematology Oncology Associates, P.C.
New York, New York 10016
United StatesSite Not Available
Manhattan Hematology Oncology Associates, Pc
New York, New York 10016
United StatesSite Not Available
Clinical Research Alliance, Inc
Westbury, New York 11590-5119
United StatesSite Not Available
Oncology Associates of Oregon - Willamette Valley Cancer
Eugene, Oregon 97401
United StatesActive - Recruiting
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon 97401
United StatesSite Not Available
St Lukes University Health Network
Bethlehem, Pennsylvania 18015
United StatesSite Not Available
St. Luke's University Health Network
Bethlehem, Pennsylvania 18015
United StatesActive - Recruiting
Abington Hematology Oncology Associates
Drexel Hill, Pennsylvania 19026
United StatesSite Not Available
St Lukes University Health Network
Fountain Hill, Pennsylvania 18015-1153
United StatesSite Not Available
Abington Hematology Oncology Associates
Horsham, Pennsylvania 19044-2331
United StatesSite Not Available
Alliance Cancer Specialist
Horsham, Pennsylvania 19044
United StatesActive - Recruiting
Tennessee Oncology
Nashville, Tennessee 37203
United StatesActive - Recruiting
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee 37203-1619
United StatesSite Not Available
Texas Oncology Amarillo
Amarillo, Texas 79106-1781
United StatesSite Not Available
Texas Oncology-Amarillo
Amarillo, Texas 79106
United StatesActive - Recruiting
Texas Oncology Arlington South
Arlington, Texas 76014
United StatesSite Not Available
Texas Oncology-Arlington South
Arlington, Texas 76012
United StatesSite Not Available
Texas Oncology
Austin, Texas 78641
United StatesSite Not Available
Texas Oncology Tyler Longview
Austin, Texas 78705-1163
United StatesSite Not Available
Baylor Research Institute
Dallas, Texas 75246-2079
United StatesSite Not Available
Texas Oncology, P.A. - Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75246
United StatesActive - Recruiting
Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas 76104
United StatesSite Not Available
Texas Oncology Fort Worth Cancer Center
Fort Worth, Texas 76104-2150
United StatesSite Not Available
Texas Oncology McAllen South Second Street
McAllen, Texas 78503
United StatesSite Not Available
Texas Oncology-McAllen South Second Street
McAllen, Texas 78503
United StatesActive - Recruiting
Texas Oncology (West ) Usor
Round Rock, Texas 78681
United StatesSite Not Available
Texas Oncology Tyler Longview
Tyler, Texas 75702
United StatesSite Not Available
Texas Oncology, P.A. - Tyler
Tyler, Texas 75702
United StatesActive - Recruiting
Us Oncology Virginia Cancer Specialists, Pc
Fairfax, Virginia 22031-4629
United StatesSite Not Available
Virginia Cancer Specialists
Gainesville, Virginia 20155
United StatesSite Not Available
Virginia Oncology Associates
Norfolk, Virginia 23502-2800
United StatesSite Not Available
Virginia Oncology Associates Hampton
Virginia Beach, Virginia 23456-0019
United StatesSite Not Available
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109-4433
United StatesSite Not Available
Medical Oncology Associates
Spokane, Washington 99208-1129
United StatesSite Not Available
Green Bay Oncology
Green Bay, Wisconsin 54307
United StatesSite Not Available
SSM Health Cancer Care
Madison, Wisconsin 53715
United StatesActive - Recruiting
Ssm Health Cancer Care Dean Medical Center
Madison, Wisconsin 53717-1959
United StatesSite Not Available
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