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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

Must not have

Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained

Female patients who are pregnant are ineligible (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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a woman able to have children and have a negative pregnancy test.

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I am not pregnant.

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My cancer has spread to my bone marrow.

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I have had hepatitis B in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 11Eligibility criteria met