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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Christos E. Emmanouilides, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068714

NCT ID:

NCT00020800

Start Date:

September 2001

Completion Date:

Related Keywords:

  • Lymphoma
  • Waldenström macroglobulinemia
  • Lymphoma
  • Waldenstrom Macroglobulinemia

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Cedars-Sinai Medical CenterLos Angeles, California  90048
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
Tuft-New England Medical CenterBoston, Massachusetts  02111
Barrett Cancer CenterCincinnati, Ohio  45267-0502
Long Island Jewish Medical CenterNew Hyde Park, New York  11040