Actively Recruiting
Dose Dense Rituximab for High Risk Newly Diagnosed Acute Immune Thrombocytopenic Purpura
Led by New York Medical College · Updated on 2026-04-15
20
Participants Needed
1
Research Sites
335 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dose Dense Rituximab for High Risk Newly Diagnosed Acute Immune Thrombocytopenic Purpura
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 1 and 21 years
- Newly diagnosed immune thrombocytopenic purpura (ITP) with platelet count of 20 x 10^9 per Liter or less
- Bone marrow aspirate and biopsy performed to exclude malignancy
- Presence of at least one high-risk feature: age 10 years or older, Grade II-IV bleeding at diagnosis, ANA positivity, or no infection within 2 weeks prior to diagnosis
- Performance status of 50% or higher (Karnofsky for patients over 16 years, Lansky for 16 years and under)
- No prior treatment for ITP
- No systemic steroids at 0.5 mg/kg prednisone equivalent or higher within 2 weeks before diagnosis
- Steroids allowed only as premedication before Rituximab
- No use of thrombopoetic agonists such as eltrombopag or romiplostim
- Adequate kidney function defined as estimated creatinine clearance over 60 mL/min or over 30% of age-based GFR
- Adequate liver function with AST and/or ALT less than 5 times upper limit of normal and/or direct bilirubin less than 2 times upper limit of normal
You will not qualify if you...
- History of Grade III-IV allergic reaction to Rituximab
- Bone marrow neoplastic infiltration
- History of hepatitis B infection
- Pregnancy
- Breastfeeding unless agreeing not to breastfeed
- Female patients of childbearing potential without a negative pregnancy test
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
New York Medical College
Vahalla, New York, United States, 10595
Actively Recruiting
Research Team
E
Erin Morris, RN
CONTACT
L
Lauren Harrison, MSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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