Rituximab Plus Fludarabine in Treating Patients With Waldenstrom's Macroglobulinemia

Lymphoma Clinical Trial

Official title:

Phase II Study of Combination Rituxan (Rituximab, Mabthera) and Fludarabine Therapy in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00020800
• Other study ID #: CDR0000068714
• Secondary ID: UCLA-0101063NCI-
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2001
• Last updated: January 7, 2013
• Start date: September 2001

Study information

• Verified date: January 2013
• Source: Jonsson Comprehensive Cancer Center
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Waldenstrom Macroglobulinemia

Intervention

Biological:
• rituximab

Drug:
• fludarabine phosphate

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Chedoke-McMaster Hospitals	Hamilton	Ontario
Sweden	Huddinge University Hospital	Stockholm
United Kingdom	Saint Bartholomew's Hospital	London	England
United States	Marlene and Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Tuft-New England Medical Center	Boston	Massachusetts
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	Barrett Cancer Center	Cincinnati	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Holden Comprehensive Cancer Center	Iowa City	Iowa
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Arizona Cancer Center	Tucson	Arizona
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Sweden,  United Kingdom, 

References & Publications (1)

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 Waldenström macroglobulinemia. Blood. 200 — View Citation