NYMC207: Dose Dense Rituximab for High Risk Newly Diagnosed Acute Immune Thrombocytopenic Purpura

Sponsor

New York Medical College (Other)

Overall Status

Recruiting

CT.gov ID

NCT04323748

Collaborator

(none)

Enrollment

Location

Arm

41.2

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenic Purpura	Drug: rituxan	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 24, 2021

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
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	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 Other Names: rituximab

Arm

Intervention/Treatment

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

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

Other Names:

rituximab

Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Medical College	Valhalla	New York	United States	10595

Sponsors and Collaborators

New York Medical College

Investigators

Principal Investigator: Jordan Milner, MD, New York Medical College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

New York Medical College

ClinicalTrials.gov Identifier:

NCT04323748

Other Study ID Numbers:

14124

First Posted:

Mar 26, 2020

Last Update Posted:

Aug 5, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Purpura

Purpura, Thrombocytopenic

Purpura, Thrombocytopenic, Idiopathic

Rituximab

Study Results

No Results Posted as of Aug 5, 2021