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

Primary Purpose

Immune Thrombocytopenic Purpura

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rituxan
Sponsored by
New York Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenic Purpura

Eligibility Criteria

1 Year - 21 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • New York Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rituximab

Arm Description

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

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
February 14, 2020
Last Updated
October 24, 2022
Sponsor
New York Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT04323748
Brief Title
Dose Dense Rituximab for High Risk Newly Diagnosed Acute Immune Thrombocytopenic Purpura
Acronym
NYMC207
Official Title
The Use of Dose Dense Rituximab for High Risk Patients With Newly Diagnosed Acute Immune Thrombocytopenic Purpura
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenic Purpura

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rituximab
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
rituxan
Other Intervention Name(s)
rituximab
Intervention Description
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 Information:
Title
To determine the safety events: Number of participants with treatment-related Grade III or higher adverse events as assessed by CTCAE v5.0.
Description
To determine the occurrence of any Grade ≥ 3 non hematologic toxicity (per CTCAE v.5) which is possibly, probably, or definitely related to rituximab.
Time Frame
1 year
Title
To determine the Response Rate
Description
To quantify remission rates for high-risk patients with acute ITP treated with a dose dense administration of rituximab.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Morris, RN
Phone
714-964-5359
Email
erin_morris@nymc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Harrison, MSN
Phone
617-285-7844
Email
lauren_harrison@nymc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Milner, MD
Organizational Affiliation
New York Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Milner, MD
First Name & Middle Initial & Last Name & Degree
Elizabeth Mintzer, CRA
Email
emintzer2@nymc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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