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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor: Mayo Clinic
Study ID: NCT00486421
Phase: EARLY_PHASE1
Status: Completed

Conditions

Nonneoplastic Condition

Eligibility Criteria

Sex: ALL
Age: 21 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Rituximab — BIOLOGICAL
375mg/m2 IV weekly times 4 (days 1, 8, 15, 22)
Prednisone — DRUG
1mg/kg/d PO, taper to off by 8 weeks

Study Details

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.

Key Dates

Start date: Jan 31, 2007
Status verified: Oct 2014
Primary completion: May 31, 2008
Completion: Nov 30, 2008

Study Design

Enrollment: 22 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: PRED & RITUX

Primary Outcome Measure

Failure-free survival at 6 months [ Time Frame: 6 months ]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Mayo Clinic	Rochester	Minnesota	55905	-

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By research site

Mayo Clinic· Rochester, MN