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Rituximab for Waldenstrom's Macroglobulinemia (WM): A Phase II Pilot Study for Untreated or Previously Treated Patients


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Rituximab for Waldenstrom's Macroglobulinemia (WM): A Phase II Pilot Study for Untreated or Previously Treated Patients


OBJECTIVES: I. Determine the response rate in previously treated and previously untreated
patients with Waldenstrom's macroglobulinemia receiving rituximab. II. Determine the
associated toxicities with this treatment, specifically the frequency of febrile or
hypotensive events, in this patient population.

OUTLINE: Patients are stratified according to prior treatment (yes vs no). Patients with
prior treatment are further stratified according to type of treatment (alkylating agents vs
purine nucleoside analogues). Patients receive rituximab IV over 4 hours on days 1, 8, 15,
and 22. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and
then annually thereafter.

PROJECTED ACCRUAL: A total of 66 patients (33 per stratum) will be accrued for this study
within 36 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Waldenstrom's macroglobulinemia confirmed by the following: Bone
marrow lymphoplasmacytosis with: Greater than 10% lymphoplasmacytic cells OR Aggregates,
sheets, lymphocytes, plasma cells, or lymphoplasmacytic cells on bone marrow biopsy AND
Measurable disease defined as quantitative IgM monoclonal protein greater than 1,000 mg/dL
Bone marrow lymphoplasmacytosis and beta-2 microglobulin in the serum are not considered
measurable Impaired bone marrow function due to infiltration by lymphoplasmacytic lymphoma
Hemoglobin less than 11 g/dL OR Serum viscosity level relative to water greater than 4.0
Symptomatic with clinically significant anemia (less than 11 g/dL), bulky lymphadenopathy
that is symptomatic, or symptoms attributable to hyperviscosity (e.g., nose bleeding,
gingival bleeding, retinal hemorrhage)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy:
Not specified Hematopoietic: See Disease Characteristics Hepatic: SGOT less than 3 times
upper limit of normal Bilirubin less than 2.0 mg/dL Renal: Creatinine no greater than 3.0
mg/dL Cardiovascular: No myocardial infarction within past 6 months No significant
arrhythmia within past 3 months Hypertension allowed provided controlled with medication
Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception Concurrent reversible complications (e.g., hyperuricemia, hyperviscosity)
allowed provided therapy for complication initiated and complications subsiding Other
prior malignancies allowed provided curatively treated and currently disease free

PRIOR CONCURRENT THERAPY: No more than 2 prior regimens allowed Prior tandem transplant
considered 2 prior regimens Chemotherapy prior to bone marrow transplantation as part of
induction considered 1 prior regimen Retreatment with same regimen (e.g., repeated
alkylating agents) considered 1 prior regimen Biologic therapy: No prior anti-CD20 therapy
At least 1 month since prior epoetin alfa No concurrent epoetin alfa for 2 months after
registration Chemotherapy: At least 28 days since prior alkylating agents At least 28 days
since prior purine nucleoside analogues Endocrine therapy: At least 28 days since prior
corticosteroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy Surgery:
Not specified Other: Concurrent digoxin to control atrial fibrillation allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Morie A. Gertz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000067738

NCT ID:

NCT00005609

Start Date:

April 2000

Completion Date:

Related Keywords:

  • Lymphoma
  • Waldenström macroglobulinemia
  • Lymphoma
  • Waldenstrom Macroglobulinemia

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Stanford University Medical CenterStanford, California  94305-5408
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Ireland Cancer CenterCleveland, Ohio  44106-5065
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Colorado Cancer Research Program, Inc.Denver, Colorado  80209-5031
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
CCOP - DuluthDuluth, Minnesota  55805
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Holden Comprehensive Cancer Center at The University of IowaIowa City, Iowa  52242-1009
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
CCOP - ColumbusColumbus, Ohio  43206
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
CCOP - EvanstonEvanston, Illinois  60201
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Veterans Affairs Medical Center - New YorkNew York, New York  10010
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - PittsburghPittsburgh, Pennsylvania  15240
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
Veterans Affairs Medical Center - ClevelandCleveland, Ohio  44106
Veterans Affairs Medical Center - NashvilleNashville, Tennessee  37212
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
CCOP - Sooner StateTulsa, Oklahoma  74136
MBCCOP-Our Lady of Mercy Cancer CenterBronx, New York  10466
Veterans Affairs Medical Center - GainsvilleGainesville, Florida  32608-1197
Guthrie Medical CenterSayre, Pennsylvania  18840