NCT04323748 · New York Medical College
Dose Dense Rituximab for High Risk Newly Diagnosed Acute Immune Thrombocytopenic Purpura
(NYMC207)
What this study 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.
View original scientific description
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.
Interventions
DRUG
rituxan
The dose dense administration of rituximab will consist of 5 doses total Days: 0, 2, 7 (± 2 days), 14 (± 2 days), and 21 (± 2 days); Dose: 375 mg/m2
Primary outcome measures
To determine the safety events: Number of participants with treatment-related Grade III or higher adverse events as assessed by CTCAE v5.0.
Time frame: 1 year
To determine the occurrence of any Grade ≥ 3 non hematologic toxicity (per CTCAE v.5) which is possibly, probably, or definitely related to rituximab.
To determine the Response Rate
Time frame: 1 year
To quantify remission rates for high-risk patients with acute ITP treated with a dose dense administration of rituximab.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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.
Where
- Vahalla, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 15, 2026 · Source of record for eligibility and locations