Actively Recruiting
The Use of Dose Dense Rituximab for High Risk Patients With Newly Diagnosed Acute Immune Thrombocytopenic Purpura
Led by New York Medical College · Updated on 2026-04-15
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a dose dense administration of Rituximab in patients aged 1 to 21 years with newly diagnosed acute immune thrombocytopenic purpura (ITP) who are considered high risk. The study aims to determine the safety and relapse rate following this specific dosing schedule, with additional correlative studies and quality of life assessments using the KIT questionnaire. Participants will receive five doses of Rituximab at 375 mg/m2 each. The doses are given on Days 0, 2, 7 (±2 days), 14 (±2 days), and 21 (±2 days). This study does not include a comparison group; all enrolled patients will receive this dose dense Rituximab regimen. During the study, researchers will monitor for treatment-related Grade III or higher adverse events over one year and evaluate the response rate. The study involves clinical assessments, laboratory tests including bone marrow biopsy to confirm diagnosis, and performance status evaluations. Quality of life will also be measured, with safety and treatment effects followed closely throughout the year-long observation period.
CONDITIONS
Brief 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 10⁹ per liter or less
- Bone marrow biopsy to rule out malignancy
- 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 before diagnosis
- Performance status of 50% or higher (Karnofsky score for those over 16 years, Lansky score for 16 years or younger)
- No prior treatment for ITP
- No systemic steroids at or above 0.5 mg/kg prednisone equivalent within 2 weeks before diagnosis
- Steroids allowed only as premedication before Rituximab
- Adequate kidney and liver function as defined in protocol
You will not qualify if you...
- History of severe (Grade III-IV) allergic reaction to Rituximab
- Bone marrow infiltration by neoplastic disease
- History of hepatitis B infection
- Pregnancy or breastfeeding
- Female patients of childbearing potential without a negative pregnancy test
- Use of thrombopoietic agonists such as eltrombopag or romiplostim during study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 3 weeks
Participants receive dose dense rituximab with five doses administered on Days 0, 2, 7 (± 2 days), 14 (± 2 days), and 21 (± 2 days).
5 visits (in-person) for rituximab dosing
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
L
Lauren Harrison, MSN
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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