Rituximab Plus Fludarabine in Treating Patients With Waldenstrom's Macroglobulinemia

NCT00020800 | Completed Phase 2

• 3 other identifiers: CDR0000068714UCLA-0101063NCI-G01-1960
• Study Type: interventional
• Target: 7
• Locations: 4 countries
• Sites: 18

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.

Conditions

Lymphoma

Keywords

Waldenström macroglobulinemia

Interventions

rituximab BIOLOGICAL

fludarabine phosphate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (18)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242-1009, United States

Location

Marlene and Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Tuft-New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Barrett Cancer Center

Cincinnati, Ohio, 45267-0502, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Chedoke-McMaster Hospitals

Hamilton, Ontario, L8N 3Z5, Canada

Location

Huddinge University Hospital

Stockholm, SE-141 86, Sweden

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Related 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 Waldenstrom macroglobulinemia. Blood. 2009 Apr 16;113(16):3673-8. doi: 10.1182/blood-2008-09-177329. Epub 2008 Nov 17.

  PMID: 19015393 RESULT

MeSH Terms

Conditions

Lymphoma; Waldenstrom Macroglobulinemia

Interventions

Rituximab; fludarabine phosphate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Christos E. Emmanouilides, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: September 1, 2001
• Primary Completion: April 1, 2003
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

SE (1); US (14); CA (2); GB (1)