Pilot Study of Rituximab for the Treatment of Acute Immune Thrombocytopenic Purpura (ITP)

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the feasibility of a randomized, double blind, placebo controlled trial of add-on rituximab for non-splenectomized adults with acute immune thrombocytopenic purpura (ITP).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Collaborator: Hoffmann-La Roche
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Non-splenectomized patients with acute ITP, where "acute ITP" is defined as a platelet count below 30 at the time that standard treatment was recommended by a physician and for which no treatment had been received for the preceding 30 days.

• Must be receiving standard ITP treatment.

Exclusion Criteria:

• Cardiac arrhythmia.

• Uncontrolled hypertension or inability to hold antihypertensive medications for 12 hours prior to and throughout study drug infusions.

• Known coronary artery disease, angina pectoris or myocardial infarction within the last year.

• Significant pulmonary disease within the last year.

• Stroke, transient ischemic attack or venous thrombosis within the last year.

• Secondary causes of thrombocytopenia (splenomegaly [palpable spleen or radiologically confirmed >14 cm], drug-induced thrombocytopenia, hereditary thrombocytopenia, microangiopathic hemolytic anemia, myelodysplastic syndrome).

• Chronic lymphocytic leukemia or lymphoma.

• Active or metastatic cancer.

• History of hepatitis B or C or HIV.

• Active infection in the 4 weeks before randomization.

• Inherited coagulation factor deficiency.

• Aspirin, aspirin-containing compounds, salicylates, non-steroidal anti-inflammatory medications (NSAIDS) medications, clopidogrel or ticlopidine in the 7 days preceding study drug infusions; vitamin K antagonists (warfarin) in the 3 days preceding study drug infusions; unfractionated heparin or low molecular weight heparin in the 24 hours preceding study drug infusions.

• Elevated INR or prolonged PTT; LDH, serum creatinine, liver function tests (AST/SGOT, ALT/SGPT, alkaline phosphatase, total bilirubin) increased more than 1.5 times upper limit of normal.

• Prior rituximab treatment.

• Unable to schedule 4 weekly study infusions.

• Pregnancy or breastfeeding.

• Known sensitivity to murine proteins, Chinese Hamster Ovary (CHO) cell proteins or to any component of rituximab.

• Participation in another clinical trial.

• Geographic inaccessibility.

• Failure to provide written informed consent.

• Any additional laboratory test result, health related illness or other diagnosis which, in the opinion of the treating physician, may put the subject's health or safety at risk.