Recruiting

Phase 1

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

Sponsor:

New York Medical College

Code:

NCT04323748

Conditions

Immune Thrombocytopenic Purpura

Eligibility Criteria

Sex: All

Age: 1 - 21

Healthy Volunteers: Not accepted

Interventions

rituxan

Study Details

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

Study ID

NCT04323748

Start date

Feb 24, 2021

Status verified date

Apr, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 1 - 21

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: rituximab

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

Interventions

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 measure

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 Response Rate [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Erin Morris, RN

714-964-5359 erin_morris@nymc.edu

Lauren Harrison, MSN

617-285-7844 lauren_harrison@nymc.edu

Locations

New York Medical College

Recruiting

Vahalla, New York, United States, 10595

Contacts

Edo Schaefer, MD

eschafe@nymc.edu

More Information

Sponsor

New York Medical College

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York Medical College on 2026-04-15.