Dose Dense Rituximab for High Risk Newly Diagnosed Acute Immune Thrombocytopenic Purpura (NYMC207)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04323748|
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : August 5, 2021
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
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
- 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.
- 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.
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
|Contact: Erin Morris, RNfirstname.lastname@example.org|
|Contact: Lauren Harrison, MSNemail@example.com|
|United States, New York|
|New York Medical College||Recruiting|
|Valhalla, New York, United States, 10595|
|Contact: Jordan Milner, MD|
|Contact: Elizabeth Mintzer, CRA firstname.lastname@example.org|
|Principal Investigator:||Jordan Milner, MD||New York Medical College|