Rituximab and Prednisone as First-Line Therapy in Treating Patients With Immune Thrombocytopenic Purpura

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Prednisone; Rituximab

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