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

NCT04323748 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 14124
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immune Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (2)

• To determine the safety events: Number of participants with treatment-related Grade III or higher adverse events as assessed by CTCAE v5.0.

  To determine the occurrence of any Grade ≥ 3 non hematologic toxicity (per CTCAE v.5) which is possibly, probably, or definitely related to rituximab.

  1 year

• To determine the Response Rate

  To quantify remission rates for high-risk patients with acute ITP treated with a dose dense administration of rituximab.

  1 year

Study Arms (1)

rituximab

EXPERIMENTAL

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

Drug: rituxan

Interventions

rituxan DRUG

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

Also known as: rituximab

rituximab

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York Medical College: lead

Study Sites (1)

New York Medical College

Vahalla, New York, 10595, United States

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Edo Scahefer, MD

  New York Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Morris, RN

CONTACT

714-964-5359; erin_morris@nymc.edu

Lauren Harrison, MSN

CONTACT

617-285-7844; lauren_harrison@nymc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: March 26, 2020
• Study Start: February 24, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)