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Phase II Pilot Study Of Rituximab Plus CHOP In Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Phase II Pilot Study Of Rituximab Plus CHOP In Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia


OBJECTIVES:

- Determine the response rate of patients with newly diagnosed Waldenstrom's
macroglobulinemia treated with rituximab, cyclophosphamide, doxorubicin, vincristine,
and prednisone.

- Determine the associated toxic effects of this regimen, specifically the frequency of
febrile neutropenia, in these patients.

- Determine the progression-free survival of patients treated with this regimen.

- Correlate baseline cytogenetic features and gene expression profiles with response in
patients treated with this regimen.

OUTLINE: This is a pilot, multicenter study.

Patients receive rituximab intravenously (IV) over approximately 4 hours, cyclophosphamide
IV over 5-30 minutes, doxorubicin IV over 5-15 minutes, and vincristine IV over 1 minute on
day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days
for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually for 5 years.

ACTUAL ACCRUAL: A total of 16 patients were accrued for this study.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response to Treatment

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Rafat Abonour, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000301634

NCT ID:

NCT00060346

Start Date:

June 2004

Completion Date:

August 2012

Related Keywords:

  • Lymphoma
  • Waldenstrom macroglobulinemia
  • Rituximab
  • CHOP
  • Lymphoma
  • Waldenstrom Macroglobulinemia

Name

Location

Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
MeritCare Bemidji Bemidji, Minnesota  56601
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
Meeker County Memorial Hospital Lichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's Hospital St Paul, Minnesota  55102
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Minnesota Oncology Hematology, PA - Woodbury Woodbury, Minnesota  55125
HealthEast Cancer Care at Woodwinds Health Campus Woodbury, Minnesota  55125
MeritCare Broadway Fargo, North Dakota  58122
CCOP - MeritCare Hospital Fargo, North Dakota  58122
Aultman Cancer Center at Aultman Hospital Canton, Ohio  44710-1799
St. Rita's Medical Center Lima, Ohio  45801
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Geisinger Medical Group - Scenery Park State College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Montana Cancer Consortium Billings, Montana  59101
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
CCOP - Grand Rapids Grand Rapids, Michigan  49503
CCOP - Scott and White Hospital Temple, Texas  76508
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
John Stoddard Cancer Center Des Moines, Iowa  50309
Great Falls Clinic Great Falls, Montana  59405
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Wilford Hall Medical Center Lackland Air Force Base, Texas  78236-5300
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Interlakes Oncology/Hematology PC Rochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Hunterdon Regional Cancer Center at Hunterdon Medical Center Flemington, New Jersey  08822
Our Lady of Mercy Medical Center Comprehensive Cancer Center Bronx, New York  10466
Lewistown Hospital Lewistown, Pennsylvania  17044
Mount Nittany Medical Center State College, Pennsylvania  16803
Southwest Medical Center Liberal, Kansas  67901
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Holland Community Hospital Holland, Michigan  49423
Hackley Hospital Muskegon, Michigan  49443
Munson Medical Center Traverse City, Michigan  49684
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289
Spectrum Health Hospital - Butterworth Campus Grand Rapids, Michigan  49503
Elkhart General Hospital Elkhart, Indiana  46515
Howard Community Hospital Kokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees, New Jersey  08043
Beebe Medical Center Lewes, Delaware  19958
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Reid Hospital & Health Care Services, Incorporated Richmond, Indiana  47374
Genesis Medical Center - West Campus Davenport, Iowa  52804
Genesis Regional Cancer Center at Genesis Medical Center Davenport, Iowa  52803
Mercy Capitol Hospital Des Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des Moines West Des Moines, Iowa  50266
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
St. Francis Comprehensive Cancer Center Topeka, Kansas  66606
Mecosta County Medical Center Big Rapids, Michigan  49307
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Wayne Radiation Oncology Goldsboro, North Carolina  27534
Wilson Medical Center Wilson, North Carolina  27893-3428
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Community Oncology Group at Cleveland Clinic Cancer Center Independence, Ohio  44131
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Cleveland Clinic - Wooster Wooster, Ohio  44691
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Danville Regional Medical Center Danville, Virginia  24541
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City, Iowa  50401
William N. Wishard Memorial Hospital Indianapolis, Indiana  46202
McFarland Clinic, PC Ames, Iowa  50010
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cotton-O'Neil Cancer Center Topeka, Kansas  66606
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Union Hospital Cancer Program at Union Hospital Elkton MD, Maryland  21921
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Saint Louis University Cancer Center Saint Louis, Missouri  63110
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Metro Health Hospital Grand Rapids, Michigan  49506
Billings Clinic Cancer Center Billings, Montana  59107-5100
Guardian Oncology and Center for Wellness Missoula, Montana  59804
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
AnMed Cancer Center Anderson, South Carolina  29621