Closely spaced rituximab doses for newly diagnosed immune thrombocytopenic purpura
Tests rituximab given in closely spaced doses for newly diagnosed immune thrombocytopenic purpura.
Key facts
- Who runs it
- New York Medical College
- Where
- Vahalla, United StatesSee the site
- Trial code
- Registry title
- Dose Dense Rituximab for High Risk Newly Diagnosed Acute Immune Thrombocytopenic Purpura
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 20 people, planned
- Started
- 24 Feb 2021
- Expected to end
- 31 Jul 2027
- Type of study
- Interventional
- Treatments tested
- rituxan
- Record updated
- 15 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and young people with newly diagnosed immune thrombocytopenic purpura (ITP), a low platelet disorder, who have high-risk features. All get rituximab given in closely spaced doses.
- Age
- 1 year to 21 years
- Sex
- All sexes
- Disease stage
- Newly diagnosed ITP with a platelet count of ≤ 20 x 109 per Liter. At least one high-risk feature: age ≥ 10 years, Grade II-IV bleeding at diagnosis, ANA positivity, or no infection within 2 weeks before diagnosis. Performance status ≥ 50%.
- Earlier treatment
- No earlier treatment for ITP. No systemic steroids ≥ 0.5 mg/kg prednisone (or equivalent) within 2 weeks before diagnosis. People who get eltrombopag or romiplostim are taken off the trial.
- Biomarker or test result
- Platelet count of ≤ 20 x 109 per Liter. ANA positivity counts as one possible high-risk feature. Kidney and liver tests must be within set limits.
Main reasons for not taking part
- Severe (Grade III-IV) allergic reaction to rituximab in the past
- Cancer cells in the bone marrow
- History of hepatitis B infection
- Pregnancy, or breastfeeding unless agreeing to stop
- Women who can become pregnant without a negative pregnancy test
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
- High-risk features : In addition, patients must have one of more of the following high-risk criteria:; Age ≥ 10 years; Grade II-IV bleeding at diagnosis; ANA positivity; No history of preceding infection within 2 weeks prior to ITP diagnosis
- Performance Status: Patients must have a performance status ≥ 50%. Use Karnofsky for patients > 16 years of age and Lansky for patients less than or equal to 16 years of age. See Appendix I for performance score
- Prior Therapy; Patients may not have received any treatment for ITP prior to start of therapy; Patients may not receive systemic steroids ≥ 0.5 mg/kg prednisone (or equivalent) within 2 weeks prior to diagnosis
- Concomitant Medications Restrictions:; Steroids are only warranted as premedication prior to rituximab; Patients who receive thrombopoetic agonists, eltrombopag or romiplostim will be taken off protocol
- Organ Function Requirements; Adequate Renal Function Defined As: estimated CrCl > 60 mL/min or >30% of GFR for age based on the Schwartz formula; Adequate Liver Function Defined As: AST and/or ALT less than 5 times the upper limit of normal, and/or direct bilirubin less than the 2 times of the upper limit of normal
Who cannot take part
- Patients with a history of Grade III-IV allergic reaction to rituximab
- Patients with a history of hepatitis B infection
- Patients with bone marrow neoplastic infiltration
- Pregnancy and Breast Feeding; Female patients who are pregnant are ineligible (insert the reason: "due to risks of fetal and teratogenic adverse events as seen in animal/human studies" or "since there is yet no available information regarding human fetal or teratogenic toxicities"); Lactating females are not eligible unless they have agreed not to breastfeed their infants; Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 21 years old?
Where in United States
- New York Medical CollegeVahalla, United StatesContact: Edo Schaefer, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
Correlative studies will be performed as outlined in the appendices.
Quality of Life will be measured using the KIT as outlined in the protocol.
The group in the trial
- rituximabTreatment being tested
All patients enrolled will receive the dose dense administration of rituximab. Five total doses will be administered on Days: 0, 2, 7 (± 2 days), 14 (± 2 days), and 21 (± 2 days); Dose: 375 mg/m2
Treatment: rituxan
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Use of Dose Dense Rituximab for High Risk Patients With Newly Diagnosed Acute Immune Thrombocytopenic Purpura
- Plain-language title
- Closely spaced rituximab doses for newly diagnosed immune thrombocytopenic purpuraGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT04323748, who can take part
- Record updated
- 15 April 2026