Study Stopped
slow accrual
Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia
Phase II Pilot Study Of Rituximab Plus CHOP In Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia
3 other identifiers
interventional
16
1 country
153
Brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with newly diagnosed Waldenstrom's macroglobulinemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 lymphoma
Started Oct 2004
Typical duration for phase_2 lymphoma
153 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2003
CompletedFirst Posted
Study publicly available on registry
May 7, 2003
CompletedStudy Start
First participant enrolled
October 5, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
February 12, 2013
CompletedJune 29, 2023
June 1, 2023
7.2 years
May 6, 2003
January 10, 2013
June 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response to Treatment
Objective response assessed using standard myeloma response criteria. Objective response is defined as a \> 50% reduction in the quantitative IgM or M-Spike levels from baseline levels. Response must be documented by two measurements separated by at least 3 weeks.
Every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry
Study Arms (1)
Rituximab + CHOP
EXPERIMENTALRituximab 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
Interventions
Rituximab is given intravenously. The initial rate is 50 mg/hr for the 1st hour. If no toxicity, the rate may be escalated in 50 mg/hr increments at 30-minute intervals to a maximum of 400 mg/hr. If the first dose is well tolerated, the initial rate for subsequent dose is 100 mg/hr, increased in 100 mg/hr increments at 30-minute intervals, not to exceed 400 mg/hr. If the patient experiences fever and rigors, the antibody infusion is discontinued. The severity of the side effects should be evaluated. If the symptoms improve, the infusion is continued initially at half the previous rate. Following the antibody infusion, the intravenous line should be maintained for medications as needed. If there are no complications after one hour of observation, the intravenous line may be discontinued.
Cyclophosphamide will be given at a dosage of 750 mg/m² intravenously on day 1 of each cycle (1 cycle =21 days) for 6 cycles. Dose is based on surface area calculated based on actual body weight. The drug should be administered as a rapid IV infusion over 5 to 30 minutes.
Doxorubicin will be given intravenously at a dosage of 50 mg/m² on day 1 of each cycle for 6 cycles (1 cycle =21 days). Dose is based on surface area calculated based on actual body weight. Doxorubicin should be administered as a continuous infusion into tubing of a freely flowing intravenous line for 5 -15 minutes. Avoid extravasation.
Prednisone will be administered at 100 mg/m² orally, days 1-5 of each cycle for 6 cycles (1 cycle =21 days). Dose is based on surface area calculated based on actual body weight.
Vincristine will be administered 1.4 mg/m² intravenously (Maximum dose = 2.0 mg) on day 1 of each cycle for 6 cycles (1 cycle =21 days). Dose is based on surface area calculated based on actual body weight. Given as IV push over 1 minute, using extravasation precautions.
Eligibility Criteria
You may qualify if:
- 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:
- +9 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (153)
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, 60507, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, 60435, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, 46107, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202-5289, United States
William N. Wishard Memorial Hospital
Indianapolis, Indiana, 46202, United States
Howard Community Hospital
Kokomo, Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, 46360, United States
Reid Hospital & Health Care Services, Incorporated
Richmond, Indiana, 47374, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Saint Joseph Regional Medical Center
South Bend, Indiana, 46617, United States
McFarland Clinic, PC
Ames, Iowa, 50010, United States
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, 52803, United States
Genesis Medical Center - West Campus
Davenport, Iowa, 52804, United States
Mercy Capitol Hospital
Des Moines, Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
John Stoddard Cancer Center
Des Moines, Iowa, 50316-2301, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, 50401, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, 50266, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068, United States
Southwest Medical Center
Liberal, Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67042, United States
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, 67401, United States
Cotton-O'Neil Cancer Center
Topeka, Kansas, 66604, United States
St. Francis Comprehensive Cancer Center
Topeka, Kansas, 66606, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67203, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156, United States
Union Hospital Cancer Program at Union Hospital
Elkton, Maryland, 21921, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, 49017, United States
Mecosta County Medical Center
Big Rapids, Michigan, 49307, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, 49503, United States
Spectrum Health Hospital - Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Metro Health Hospital
Grand Rapids, Michigan, 49506, United States
Holland Community Hospital
Holland, Michigan, 49423, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
Hackley Hospital
Muskegon, Michigan, 49442, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
MeritCare Bemidji
Bemidji, Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Meeker County Memorial Hospital
Litchfield, Minnesota, 55355, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, 55109, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, 55422-2900, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, 55101, United States
HealthEast Cancer Care at St. Joseph's Hospital
Saint Paul, Minnesota, 55102, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, 55379, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury, Minnesota, 55125, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, 55125, United States
Saint Louis University Cancer Center
St Louis, Missouri, 63110, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, 59101, United States
Billings Clinic Cancer Center
Billings, Montana, 59107-5100, United States
Billings Clinic - Downtown
Billings, Montana, 59107-7000, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
St. James Healthcare Cancer Care
Butte, Montana, 59701, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
St. Peter's Hospital
Helena, Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Center
Missoula, Montana, 59801, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59807, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, 08822, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, 08053, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees Township, New Jersey, 08043, United States
Interlakes Oncology/Hematology PC
Rochester, New York, 14623, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
The Bronx, New York, 10466, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534, United States
Wayne Radiation Oncology
Goldsboro, North Carolina, 27534, United States
Rutherford Hospital
Rutherfordton, North Carolina, 28139, United States
Wilson Medical Center
Wilson, North Carolina, 27893-3428, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122, United States
MeritCare Broadway
Fargo, North Dakota, 58122, United States
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, 44710-1799, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital
Dayton, Ohio, 45406, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton, Ohio, 45415, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428, United States
CCOP - Dayton
Dayton, Ohio, 45429, United States
Community Oncology Group at Cleveland Clinic Cancer Center
Independence, Ohio, 44131, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429, United States
St. Rita's Medical Center
Lima, Ohio, 45801, United States
Middletown Regional Hospital
Middletown, Ohio, 45044, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, 45373-1300, United States
Cleveland Clinic - Wooster
Wooster, Ohio, 44691, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-0001, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, 16801, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
AnMed Cancer Center
Anderson, South Carolina, 29621, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls, South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, 57117-5039, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236, United States
CCOP - Scott and White Hospital
Temple, Texas, 76508, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, 82801, United States
Related Publications (1)
Abonour R, Zhang LA, Rajkumar V, et al.: Phase II pilot study of rituximab + CHOP in patients with newly diagnosed Waldenstroms macroglobulinemia, an Eastren Cooperative Oncology Group trial (study E1A02). [Abstract] Blood 110 (11): A-3616, 2007.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG Statistical Office
Study Officials
- STUDY CHAIR
Rafat Abonour, MD
Indiana University Melvin and Bren Simon Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2003
First Posted
May 7, 2003
Study Start
October 5, 2004
Primary Completion
December 1, 2011
Study Completion
August 1, 2012
Last Updated
June 29, 2023
Results First Posted
February 12, 2013
Record last verified: 2023-06