Clinical trial NCT00020800: Rituximab Plus Fludarabine in Treating Patients With Waldenstrom's Macroglobulinemia
Official title: Phase II Study of Combination Rituxan (Rituximab, Mabthera) and Fludarabine Therapy in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: Waldenström macroglobulinemia
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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 use different way to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.

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

Detailed description: OBJECTIVES:

* Determine the objective response and time to treatment failure in patients with Waldenstrom's macroglobulinemia treated with rituximab and fludarabine.
* Determine the toxicity of this regimen in these patients.
* Determine if molecular remissions are achievable in patients attaining a clinical complete response when treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV over 3-6 hours once weekly on weeks 1-4, 17, 18, 30, and 31 and fludarabine IV over 10-30 minutes once daily for 5 days on weeks 5, 9, 13, 19, 23, and 27.

Patients are followed at least every 2 months for 2 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of Waldenstrom's macroglobulinemia
* CD20 positive by bone marrow immunohistochemistry or flow cytometry
* Presence of monoclonal paraprotein
* IgM level at least 2 times upper limit of normal (ULN)

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* ECOG 0-2

Life expectancy:

* At least 6 months

Hematopoietic:

* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count greater than 25,000/mm\^3

Hepatic:

* Bilirubin less than 2.5 times ULN
* SGOT less than 2.5 times ULN

Renal:

* Creatinine less than 2.5 mg/dL

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 6 months after study
* No serious comorbid disease
* No uncontrolled bacterial, fungal, or viral infection
* No other active malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior rituximab
* No prior nucleoside analogue therapy

Chemotherapy:

* At least 30 days since prior chemotherapy

Endocrine therapy:

* At least 30 days since prior steroid therapy
* No concurrent corticosteroids

Radiotherapy:

* At least 30 days since prior radiotherapy

Surgery:

* Not specified

Other:

* No more than 2 prior courses of therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Chicago
country: United States
facility: Rush-Presbyterian-St. Luke's Medical Center
state: Illinois
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center
state: Iowa
city: Baltimore
country: United States
facility: Marlene and Stewart Greenebaum Cancer Center, University of Maryland
state: Maryland
city: Boston
country: United States
facility: Tuft-New England Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Cincinnati
country: United States
facility: Barrett Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Hamilton
country: Canada
facility: Chedoke-McMaster Hospitals
state: Ontario
city: Stockholm
country: Sweden
facility: Huddinge University Hospital
city: London
country: United Kingdom
facility: Saint Bartholomew's Hospital
state: England
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Christos E. Emmanouilides, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Treon SP, Branagan AR, Ioakimidis L, Soumerai JD, Patterson CJ, Turnbull B, Wasi P, Emmanouilides C, Frankel SR, Lister A, Morel P, Matous J, Gregory SA, Kimby E. Long-term outcomes to fludarabine and rituximab in Waldenstrom macroglobulinemia. Blood. 2009 Apr 16;113(16):3673-8. doi: 10.1182/blood-2008-09-177329. Epub 2008 Nov 17.