Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring Waldenstrom macroglobulinemia, Rituximab, CHOP
Eligibility Criteria
INCLUSION CRITERIA: Diagnosis of Waldenstrom's macroglobulinemia confirmed by the presence of the following: Bone marrow lymphoplasmacytosis with: > 10% lymphoplasmacytic cells OR aggregates or sheets of one of the following: lymphocytes, plasma cells or lymphoplasmacytic cells on the bone marrow biopsy (measured within 4 weeks prior to registration) Measurable disease defined as a quantitative immunoglobulin M (IgM) monoclonal protein of > 1,000 mg/dL obtained within 4 weeks prior to registration Cluster of differentiation 20 (CD20) positive stain of bone marrow or lymph node samples obtained < 8 weeks prior to registration Impaired bone marrow function due to infiltration by lymphoplasmacytic lymphoma, defined by 1 of the following: Hemoglobin no greater than 11 g/dL Serum viscosity level relative to water of at least 4.0 centipoise Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 75,000/mm^3 Bilirubin no greater than 3.0 mg/dL Aspartate aminotransferase (AST) no greater than 3 times upper limit of normal Creatinine no greater than 3.0 mg/dL Age of 18 and over ECOG (Eastern Cooperative Oncology Group) performance status 0-1 Must be symptomatic with 1 of the following: Clinically significant anemia (hemoglobin no greater than 11 g/dL) Bulky lymphadenopathy Symptoms attributable to hyperviscosity (e.g., nose bleeding, gingival bleeding, or retinal hemorrhage) History of heart disease allowed only if 1 of the following is demonstrated by echocardiography, multigated acquisition scan (MUGA), exercise MUGA, or coronary catheterization: Ejection fraction of at least 45% Normal fractional shortening of the left ventricle Must have been tested for hepatitis B surface antigen within 2 weeks of registration Negative pregnancy test Fertile patients must use effective contraception EXCLUSION CRITERIA: Prior treatment for Waldenstrom's macroglobulinemia Prior anti-CD20 therapy Concurrent steroids exceeding 10 mg prednisone (or equivalent) per day Prior irradiation if less than 4 weeks had elapsed prior to registration and the date of last treatment Prior anthracyclines Prior malignancy except curatively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancer curatively treated with surgery alone and from which patient has been disease free for at least 5 years Active heart disease Pregnant or nursing Myocardial infarction within the past 3 months Congestive heart failure Symptomatic ventricular arrhythmia
Sites / Locations
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Beebe Medical Center
- CCOP - Christiana Care Health Services
- Rush-Copley Cancer Care Center
- Joliet Oncology-Hematology Associates, Limited - West
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Elkhart General Hospital
- Indiana University Melvin and Bren Simon Cancer Center
- William N. Wishard Memorial Hospital
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Saint Anthony Memorial Health Centers
- Reid Hospital & Health Care Services, Incorporated
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Saint Joseph Regional Medical Center
- McFarland Clinic, PC
- Genesis Regional Cancer Center at Genesis Medical Center
- Genesis Medical Center - West Campus
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center
- Mercy Cancer Center at Mercy Medical Center - North Iowa
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Tammy Walker Cancer Center at Salina Regional Health Center
- Cotton-O'Neil Cancer Center
- St. Francis Comprehensive Cancer Center
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Union Hospital Cancer Program at Union Hospital
- Battle Creek Health System Cancer Care Center
- Mecosta County Medical Center
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Spectrum Health Hospital - Butterworth Campus
- Metro Health Hospital
- Holland Community Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Hackley Hospital
- Lakeland Regional Cancer Care Center - St. Joseph
- Munson Medical Center
- MeritCare Bemidji
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- HealthEast Cancer Care at St. Joseph's Hospital
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Ridgeview Medical Center
- HealthEast Cancer Care at Woodwinds Health Campus
- Minnesota Oncology Hematology, PA - Woodbury
- Saint Louis University Cancer Center
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare Cancer Care Services
- Billings Clinic Cancer Center
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Great Falls Clinic - Main Facility
- Great Falls Clinic
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
- Cancer Institute of New Jersey at Cooper - Voorhees
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- Our Lady of Mercy Medical Center Comprehensive Cancer Center
- Interlakes Oncology/Hematology PC
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Wayne Memorial Hospital, Incorporated
- Wayne Radiation Oncology
- Rutherford Hospital
- Wilson Medical Center
- CCOP - MeritCare Hospital
- MeritCare Broadway
- Aultman Cancer Center at Aultman Hospital
- Cleveland Clinic Taussig Cancer Center
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Community Oncology Group at Cleveland Clinic Cancer Center
- Charles F. Kettering Memorial Hospital
- St. Rita's Medical Center
- Middletown Regional Hospital
- UVMC Cancer Care Center at Upper Valley Medical Center
- Cleveland Clinic - Wooster
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Geisinger Medical Center
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Lewistown Hospital
- Geisinger Medical Group - Scenery Park
- Mount Nittany Medical Center
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- AnMed Cancer Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Brooke Army Medical Center
- Wilford Hall Medical Center
- CCOP - Scott and White Hospital
- Danville Regional Medical Center
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
Rituximab + CHOP
Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by: Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily