Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005609
• Other study ID #: CDR0000067738
• Secondary ID: E-3A98
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2000
• Last updated: August 14, 2013
• Start date: April 2000
• Est. completion date: February 2004

Study information

• Verified date: September 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have Waldenstrom's macroglobulinemia.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Waldenstrom Macroglobulinemia

Intervention

Biological:
• rituximab

Locations

Country	Name	City	State
Puerto Rico	MBCCOP - San Juan	San Juan
Puerto Rico	Veterans Affairs Medical Center - San Juan	San Juan
South Africa	Pretoria Academic Hospitals	Pretoria
United States	Veterans Affairs Medical Center - Albany	Albany	New York
United States	CCOP - Ann Arbor Regional	Ann Arbor	Michigan
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Albert Einstein Comprehensive Cancer Center	Bronx	New York
United States	MBCCOP-Our Lady of Mercy Cancer Center	Bronx	New York
United States	Veterans Affairs Medical Center - Brooklyn	Brooklyn	New York
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois
United States	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Veterans Affairs Medical Center - Cleveland	Cleveland	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	CCOP - Central Illinois	Decatur	Illinois
United States	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia
United States	CCOP - Colorado Cancer Research Program, Inc.	Denver	Colorado
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	Cancer Center and Beckman Research Institute, City of Hope	Duarte	California
United States	CCOP - Duluth	Duluth	Minnesota
United States	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey
United States	CCOP - Evanston	Evanston	Illinois
United States	CCOP - Merit Care Hospital	Fargo	North Dakota
United States	Veterans Affairs Medical Center - Gainsville	Gainesville	Florida
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Veterans Affairs Medical Center - Indianapolis (Roudebush)	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center at The University of Iowa	Iowa City	Iowa
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Veterans Affairs Medical Center - Madison	Madison	Wisconsin
United States	CCOP - Marshfield Medical Research and Education Foundation	Marshfield	Wisconsin
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Veterans Affairs Medical Center - Nashville	Nashville	Tennessee
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York
United States	Veterans Affairs Medical Center - New York	New York	New York
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Veterans Affairs Medical Center - Palo Alto	Palo Alto	California
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Hahnemann University Hospital	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Veterans Affairs Medical Center - Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Guthrie Medical Center	Sayre	Pennsylvania
United States	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	Stanford University Medical Center	Stanford	California
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Veterans Affairs Medical Center - Tampa (Haley)	Tampa	Florida
United States	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio
United States	CCOP - Sooner State	Tulsa	Oklahoma
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	CCOP - Christiana Care Health Services	Wilmington	Delaware
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico,  South Africa, 

References & Publications (3)

Gertz MA, Abonour R, Heffner LT, Greipp PR, Uno H, Rajkumar SV. Clinical value of minor responses after 4 doses of rituximab in Waldenström macroglobulinaemia: a follow-up of the Eastern Cooperative Oncology Group E3A98 trial. Br J Haematol. 2009 Dec;147( — View Citation

Gertz MA, Rue M, Blood E, Kaminer LS, Vesole DH, Greipp PR. Multicenter phase 2 trial of rituximab for Waldenström macroglobulinemia (WM): an Eastern Cooperative Oncology Group Study (E3A98). Leuk Lymphoma. 2004 Oct;45(10):2047-55. — View Citation

Ghobrial IM, Fonseca R, Greipp PR, Blood E, Rue M, Vesole DH, Gertz MA; Eastern Cooperative Oncology Group. Initial immunoglobulin M 'flare' after rituximab therapy in patients diagnosed with Waldenstrom macroglobulinemia: an Eastern Cooperative Oncology — View Citation