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Monoclonal Antibodies

Dose-Dense Rituximab for ITP (NYMC207 Trial)

Phase 1
Recruiting
Led By Jordan Milner, MD
Research Sponsored by New York Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate Renal Function Defined As: estimated CrCl > 60 mL/min or >30% of GFR for age based on the Schwartz formula
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

NYMC207 Trial Summary

This trial is to study if a more frequent administration of Rituximab leads to less relapses in ITP patients and to measure the quality of life during and after treatment.

Who is the study for?
This trial is for young people (1-21 years old) with a new diagnosis of acute immune thrombocytopenic purpura (ITP), who are at high risk due to factors like being older than 10, severe bleeding, or specific antibody presence. They must have low platelet counts and good kidney and liver function. Pregnant or breastfeeding females, those with certain infections or previous ITP treatments, can't participate.Check my eligibility
What is being tested?
The study tests whether giving Rituximab more frequently ('dose dense') helps newly diagnosed high-risk ITP patients better than standard approaches. It also looks at how long patients stay in remission after this treatment and assesses their quality of life using the KIT questionnaire.See study design
What are the potential side effects?
Rituximab may cause allergic reactions, infusion-related symptoms like fever and chills, body aches, fatigue, skin rashes. There's also a risk of infections due to its effect on the immune system.

NYMC207 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is good based on tests.
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I can do most of my daily activities by myself.
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I have not received any treatment for ITP before.
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I have been recently diagnosed with ITP and my platelet count is very low.
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My liver tests are within acceptable limits.
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I haven't taken high doses of steroids in the last 2 weeks.
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I am between 1 and 21 years old.

NYMC207 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine the Response Rate
To determine the safety events: Number of participants with treatment-related Grade III or higher adverse events as assessed by CTCAE v5.0.

NYMC207 Trial Design

1Treatment groups
Experimental Treatment
Group I: rituximabExperimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

New York Medical CollegeLead Sponsor
69 Previous Clinical Trials
6,041 Total Patients Enrolled
Jordan Milner, MDPrincipal InvestigatorNew York Medical College
2 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Rituximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04323748 — Phase 1
Thrombocytopenic Purpura Research Study Groups: rituximab
Thrombocytopenic Purpura Clinical Trial 2023: Rituximab Highlights & Side Effects. Trial Name: NCT04323748 — Phase 1
Rituximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04323748 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial accept participants who are over 20 years of age?

"This medical study requires that applicants are between 1 year old and 21 years of age. There is a total of 72 trials for those younger than 18, whereas 441 studies are available for individuals over the retirement age."

Answered by AI

Are there any open slots for participants in this investigation?

"As seen on clinicaltrials.gov, the trial is presently enlisting participants and was initially advertised in February 2021 with a recent update posted in October 2022."

Answered by AI

What maladies does rituxan typically address?

"Rituxan is a popular choice of treatment for DLBCL, although it has also been proven to help treat other b-cell lymphomas and conditions such as polyangium and pemphigus vulgaris."

Answered by AI

What have been the safety implications of utilizing rituxan in humans?

"Rituxan's safety was assessed by our team with a score of 1, as the Phase 1 trial for this medication has not yet yielded comprehensive data regarding efficacy and safety."

Answered by AI

Would I qualify for admission into this clinical experiment?

"This scientific investigation is seeking 20 individuals, ranging between the tender age of 1 year and 21 years old, who are currently afflicted with purpura thrombocytopenic. In order to qualify for enrolment in this trial, patients must meet certain requirements such as a performance status score - Karnofsky for those over 16 and Lansky for younger participants; no prior therapy or preceding infection within two weeks before diagnosis; an ANA positivity test result; and lastly being at least 10 years of age."

Answered by AI

What is the scale of recruitment for this clinical experiment?

"Affirmative. Clinicaltrials.gov displays that this trial, which was established on February 24th 2021, is presently recruiting volunteers. Twenty participants are needed at a single centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dose Dense Rituximab for High Risk Newly Diagnosed Acute Immune Thrombocytopenic Purpura
2021. "Dose Dense Rituximab for High Risk Newly Diagnosed Acute Immune Thrombocytopenic Purpura". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04323748.
~1 spots leftby Jul 2024
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