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

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ClinicalTrials.gov Identifier: NCT04323748
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
New York Medical College

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 24, 2021
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2024


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 Name: rituximab




Primary Outcome Measures :
  1. 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 occurrence of any Grade ≥ 3 non hematologic toxicity (per CTCAE v.5) which is possibly, probably, or definitely related to rituximab.

  2. To determine the Response Rate [ Time Frame: 1 year ]
    To quantify remission rates for high-risk patients with acute ITP treated with a dose dense administration of rituximab.



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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323748


Contacts
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Contact: Erin Morris, RN 714-964-5359 erin_morris@nymc.edu
Contact: Lauren Harrison, MSN 617-285-7844 lauren_harrison@nymc.edu

Locations
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United States, New York
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Jordan Milner, MD         
Contact: Elizabeth Mintzer, CRA       emintzer2@nymc.edu   
Sponsors and Collaborators
New York Medical College
Investigators
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Principal Investigator: Jordan Milner, MD New York Medical College
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Responsible Party: New York Medical College
ClinicalTrials.gov Identifier: NCT04323748    
Other Study ID Numbers: 14124
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Thrombocytopenia
Immune System Diseases
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Thrombotic Microangiopathies
Blood Platelet Disorders
Hemorrhagic Disorders
Autoimmune Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents