Nonneoplastic Condition
Conditions
Keywords
idiopathic thrombocytopenic purpura
Brief 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.
Detailed description
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.
Interventions
375mg/m2 IV weekly times 4 (days 1, 8, 15, 22)
1mg/kg/d PO, taper to off by 8 weeks
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Failure-free survival at 6 months | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to platelet recovery | 1 year |
| Duration of platelet recovery | 1 year |
| Effect of treatment on prevention of spontaneous bleeding events | 1 year |
Countries
United States