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

Launched by NEW YORK MEDICAL COLLEGE · Mar 25, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Rituximab for children and young adults, aged 1 to 21, who have been newly diagnosed with a serious condition called acute immune thrombocytopenic purpura (ITP). ITP is a condition where the body does not have enough platelets, which are important for blood clotting, leading to easy bruising and bleeding. The goal of the trial is to see if giving Rituximab in a more frequent way can help improve platelet counts and reduce the chances of the condition coming back after treatment.

To participate, individuals must be diagnosed with ITP and have a very low platelet count. They should also show certain high-risk features, such as being older than 10 years or having significant bleeding at the time of diagnosis. Participants will not have received any prior treatments for ITP and must meet specific health criteria regarding their organ functions. Those who join the trial will receive the Rituximab treatment and will have their quality of life monitored throughout the study. It's important to note that pregnant or breastfeeding females cannot participate, as the treatment may pose risks. Overall, this trial aims to explore a new approach to treating ITP and to gather valuable information on its effectiveness and safety.

Gender

ALL

Eligibility criteria

• 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.