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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 CenterRochester, Minnesota  55905
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
MeritCare BemidjiBemidji, Minnesota  56601
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's HospitalSt Paul, Minnesota  55102
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
HealthEast Cancer Care at Woodwinds Health CampusWoodbury, Minnesota  55125
MeritCare BroadwayFargo, North Dakota  58122
CCOP - MeritCare HospitalFargo, North Dakota  58122
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
St. Rita's Medical CenterLima, Ohio  45801
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
John Stoddard Cancer CenterDes Moines, Iowa  50309
Great Falls ClinicGreat Falls, Montana  59405
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Interlakes Oncology/Hematology PCRochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Hunterdon Regional Cancer Center at Hunterdon Medical CenterFlemington, New Jersey  08822
Our Lady of Mercy Medical Center Comprehensive Cancer CenterBronx, New York  10466
Lewistown HospitalLewistown, Pennsylvania  17044
Mount Nittany Medical CenterState College, Pennsylvania  16803
Southwest Medical CenterLiberal, Kansas  67901
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Munson Medical CenterTraverse City, Michigan  49684
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Spectrum Health Hospital - Butterworth CampusGrand Rapids, Michigan  49503
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Beebe Medical CenterLewes, Delaware  19958
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Reid Hospital & Health Care Services, IncorporatedRichmond, Indiana  47374
Genesis Medical Center - West CampusDavenport, Iowa  52804
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Mecosta County Medical CenterBig Rapids, Michigan  49307
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Community Oncology Group at Cleveland Clinic Cancer CenterIndependence, Ohio  44131
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Cleveland Clinic - WoosterWooster, Ohio  44691
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Danville Regional Medical CenterDanville, Virginia  24541
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
William N. Wishard Memorial HospitalIndianapolis, Indiana  46202
McFarland Clinic, PCAmes, Iowa  50010
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cotton-O'Neil Cancer CenterTopeka, Kansas  66606
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Billings Clinic Cancer CenterBillings, Montana  59107-5100
Guardian Oncology and Center for WellnessMissoula, Montana  59804
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
AnMed Cancer CenterAnderson, South Carolina  29621