Dose Dense Rituximab for High Risk Newly Diagnosed Acute Immune Thrombocytopenic Purpura

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1-21
SponsorNew York Medical College

About this trial

The purpose of this study is to determine if a dose dense administration of Rituximab in newly diagnosed acute immune thrombocytopenic purpura (ITP) and determine relapse rate following this treatment.

Correlative studies will be performed as outlined in the appendices.

Quality of Life will be measured using the KIT as outlined in the protocol.

Eligibility criteria

Qualifiers

Age: Subjects must be ≥ 1 year and ≤ 21 years of age.

Diagnosis: Patients must have newly diagnosed ITP and a platelet count of ≤ 20 x 109 per Liter. Bone marrow aspirate and biopsy should be performed to rule out malignancy in the bone marrow.

Age ≥ 10 years

Grade II-IV bleeding at diagnosis

Disqualifiers

Patients with a history of Grade III-IV allergic reaction to rituximab

Patients with bone marrow neoplastic infiltration

Patients with a history of hepatitis B infection

Pregnancy and Breast Feeding

Trial design

Treatments tested in this trial

  • rituxan

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

New York Medical CollegeRecruiting10595, Vahalla, New YorkUnited StatesUnited States

Sponsors and collaborators