Rituximab and Prednisone as First-Line Therapy in Treating Patients With Immune Thrombocytopenic … (NCT00486421) | Clinical Trial Compass
CompletedEarly Phase 1
Rituximab and Prednisone as First-Line Therapy in Treating Patients With Immune Thrombocytopenic Purpura
United States22 participantsStarted 2007-01
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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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…