RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

The Use of Dose Dense Rituximab for High Risk Patients With Newly Diagnosed Acute Immune Thrombocytopenic Purpura

Quick Facts

Study Start:2021-02-24

Study Completion:2025-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04323748

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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 * 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.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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
* 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.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Erin Morris, RN

CONTACT

714-964-5359

erin_morris@nymc.edu

Lauren Harrison, MSN

CONTACT

617-285-7844

lauren_harrison@nymc.edu

Principal Investigator

Jordan Milner, MD

PRINCIPAL_INVESTIGATOR

New York Medical College

Study Locations (Sites)

New York Medical College

Valhalla, New York, 10595

United States

Collaborators and Investigators

Sponsor: New York Medical College

Jordan Milner, MD, PRINCIPAL_INVESTIGATOR, New York Medical College

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-24

Study Completion Date2025-07-31

Study Record Updates

Study Start Date2021-02-24

Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

Immune Thrombocytopenic Purpura