rituximab and prednisone as first-line therapy in treating patients with immune thrombocytopenic purpura

Conditions: Nonneoplastic Condition

Summary: rationale: rituximab and prednisone may increase the number of platelets in patients with immune thrombocytopenic purpura. purpose: this phase ii trial is studying the side effects and how well giving rituximab together with prednisone works as first-line therapy in treating patients with immune thrombocytopenic purpura.

objectives: primary * determine the efficacy of rituximab, when administered with standard prednisone treatment, in maintaining a platelet count ≥ 50,000/mm³ at 6 months without further therapies (e.g., splenectomy or other salvage therapies) in patients with immune thrombocytopenic purpura. * determine the safety of this regimen in these patients. secondary * determine the time to platelet recovery in patients treated with this regimen. * determine the duration of platelet recovery in patients treated with this regimen. * assess efficacy of this regimen in preventing spontaneous bleeding events in these patients. * determine the response in patients treated with this regimen. outline: this is a pilot study. patients receive rituximab iv on days 1, 8, 15, and 22 and oral prednisone once daily on days 1-14 followed by a taper to day 56. treatment is administered in the absence of disease relapse or unacceptable toxicity. after completion of study therapy, patients are followed periodically for up to 3 years.

Eligibility criteria:
disease characteristics: * diagnosis of immune thrombocytopenic purpura (itp) * diagnosis must be made according to american society of hematology diagnostic guidelines by a member of mayo rochester's division of hematology/oncology within the past year * itp must be confirmed by bone marrow aspiration and biopsy in all patients ≥ 60 years of age\* * bone marrow studies performed outside mayo must be reviewed by a mayo hematopathologist to confirm diagnosis and exclude evidence of other hematologic disorders note: \*bone marrow evaluation is discretionary for all other patients * requires treatment, as defined by 1 of the following parameters: * platelet count ≤ 30,000/mm³ * platelet count ≤ 50,000/mm³ with episodic bleeding (i.e., spontaneous or with minimal trauma) requiring treatment * no concurrent diagnosis of a condition known to cause secondary immune (or nonimmune) thrombocytopenia, including, but not limited to, any of the following: * rheumatological conditions, such as lupus, rheumatoid arthritis, scleroderma, or mixed connective tissue disorder * patients with positive serologies and no concurrent, clinically evident condition are eligible * hiv positive or aids * non-hodgkin's lymphoma, hodgkin's lymphoma, chronic lymphocytic lymphoma, multiple myeloma, or other malignant hematological conditions * clinically evident antiphospholipid antibody syndrome\* or heparin-induced thrombocytopenia * clinically overt liver disease, hepatitis b surface antigen positive, hepatitis c serology positive, or evidence of a microangiopathic hemolytic anemia, such as disseminated intravascular coagulation, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura, or preeclampsia note: \*positive laboratory tests without the defined clinical criteria for a diagnosis of antiphospholipid antibody syndrome is allowed patient characteristics: * ecog performance status 0-2 * creatinine ≤ 2 times upper limit of normal (uln) * direct bilirubin ≤ 1.5 times uln * total bilirubin ≤ 1.5 times uln * ast ≤ 2.5 times uln * hemoglobin ≥ 10 g/dl * wbc ≥ 3,000/mm³ * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no hypersensitivity to murine or chimeric proteins * no other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk for treatment complications * able to take a proton-pump inhibitor while on corticosteroids * no unresolved or incompletely treated infection within the past 14 days prior concurrent therapy: * no prior corticosteroid therapy since the diagnosis of itp * corticosteroid therapy is allowed for up to 14 days prior to study entry, once the baseline cbc has been established * no prior rituximab * no other concurrent therapy for itp, including androgens, iv immunoglobulins, rh_o (d) immune globulin, cyclosporine, or azathioprine sodium

Keywords: idiopathic thrombocytopenic purpura