SWOG clinical trial number
E1A02

Phase II Pilot Study of Rituximab + CHOP in Patients with Newly Diagnosed Waldenstrom's Macroglobulinemia

Closed
Phase
Published
Abbreviated Title
Newly Diagnosed Waldenstrom's Macroglobulinemia
Activated
07/15/2004
Closed
04/26/2007
Participants
NCORP, Members, Medical Oncologists, Pathologists

Research committees

Myeloma

Treatment

Cyclophosphamide Prednisone Vincristine Doxorubicin Rituximab CHOP

Eligibility Criteria Expand/Collapse

Pts must have a diagnosis of Waldenstrom's Macroglobulinemia. Pts must have impaired bone marrow function due to infiltration by lymphoplasmacytic lymphoma as defined in the protocol. No prior regimens for treatment of Waldenstrom's Macroglobulinemia allowed. Pts must not have received prior anti-CD20 therapy. Pt must not be receiving concurrent steroids greater than 10 mg prednisone (or equivalent) per day. Prior irradiation is allowed if greater than or equal to 4 weeks prior to registration have elapsed since the date of last treatment. Pts must have adequate organ function as measured by the criteria in the protocol. Pts must be greater than or equal to 18 years old. ECOG PS of less than or equal to 2. Pts must be symptomatic with one of the following: clinically significant anemia, bulky lymphadenopathy that is symptomatic, symptoms attributable to hyperviscosity, such as nose bleeding, gingival bleeding, or retinal hemorrhage. Pts must have had no prior exposure to anthracyclines. Pts must have no history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. The pt may also have had other cancer for which the pt was curatively treated with surgery alone and from which the pt has been disease free for greater than or equal to 5 years. Pt must not have active heart disease. If there is a prior history of heart disase, an ejection fraction must be performed less than or equal to 4 weeks prior to registration and should show an ejection fraction of greater than or equal to 45% or a normal fractional shortening of the left ventricle in order to be eligible. Women must not be pregnant or breast feeding. A negative pregnancy test less than or equal to 2 weeks prior to registration is required for all women of childbearing potential. Women of childbearing potential and sexually active males must use an accepted and effective method of contraception.

Publication Information Expand/Collapse

2007

Phase II pilot study of rituximab + CHOP in patients with newly diagnosed Waldenstrom's macroglobulinemia, an Eastern Cooperative Oncology Group trial (study E1A02)

R Abonour;LA Zhang;V Rajkumar;G Srkalovic;PR Greipp;R Fonseca;M Gertz Blood 110(11):#3616