|
|
 |
|
 |
|
|
|
|
Title:
|
Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimid) Alone and in Combination with Epoetin Alfa (Procrit) in Subjects with Low- or Intermediate-1 Risk MDS and Symptomatic Anemia - IRB# 09-054B
|
|
Treatments:
|
Epoetin Alfa, Lenalidomide
|
|
Disease Site:
|
Myelodysplastic Syndrome
|
|
Disease SubSite:
|
|
|
Drug Provided:
|
Epoetin Alfa, Lenalidomide
|
|
Comments:
|
|
|
Eligibility:
|
Documented diagnosis of 1 of the following: Myelodysplastic syndromes (MDS) lasting => 3 months according to WHO criteria. Disease must not be secondary to treatment with radiotherapy, chemotherapy, and/or immunotherapy for malignant or autoimmune diseases. Non-proliferative chronic myelomonocytic leukemia (WBC <12,000/mm³). International prognostic scoring system category of low- or intermediate-1-risk MDS as determined by cytogenetic analysis. Patients with cytogenetic failure and < 10% marrow blasts are eligible. Must have symptomatic anemia with hemoglobin =< 9.5 g/dL* (transfusion independent or RBC transfusion-dependent [i.e., => 2 units/month]) within the past 8 weeks. [Note: *For transfusion independent patients, a minimum of 2 pre-transfusion or un-transfused hemoglobin values are required]. Must have failed treatment with an erythropoietic growth factor or have a low probability of response to rhu-erythropoietin, as defined by the following: Prior erythropoietin failure: requires a minimum trial of =>40,000 units epoetin alfa/week x 8 weeks or equivalent dose of darbepoetin alfa for 8 weeks with failure to achieve transfusion independence in dependent patients or a failure to achieve a => 2 g rise in hemoglobin sustained for => 4 weeks in transfusion independent patients. Low erythropoietin response profile: rhu-erythropoietin and epoetin alfa-naive patients receiving => 2 U pRBC/month and serum erythropoietin => 500 mU/mL in the 8 weeks prior to randomization for a hemoglobin =< 9.5 g/dL. Patients from SWOG institutions must be registered to protocol SWOG-9007. Prior/Concurrent Therapy: See Disease Characteristics. No prior lenalidomide. Prior thalidomide allowed. More than 8 weeks since prior cytotoxic chemotherapeutic agents, erythropoietin, or experimental agents (agents that are not commercially available) for the treatment of MDS. At least 28 days since prior non-transfusion therapy, except for prophylactic hydrocortisone to prevent transfus
|
|
Participating Sites:
|
Adventist Medical Center, Northwest Cancer Specialists, Providence Milwaukie Hospital, Providence Portland Medical Center, Providence St. Vincent Medical Center, Southwest Washington Medical Center
|
|
|
|
|
 |
|
 |
|
|
|