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

The Use of Dose Dense Rituximab for High Risk Patients With Newly Diagnosed Acute Immune Thrombocytopenic Purpura

Sponsors

Lead Sponsor: New York Medical College

Source 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.

Overall Status Not yet recruiting
Start Date September 15, 2020
Completion Date July 31, 2024
Primary Completion Date July 31, 2023
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
To determine the safety events: Number of participants with treatment-related Grade III or higher adverse events as assessed by CTCAE v5.0. 1 year
To determine the Response Rate 1 year
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: rituxan

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

Arm Group Label: rituximab

Other Name: rituximab

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.

Gender: All

Minimum Age: 1 Year

Maximum Age: 21 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Allyson Flower, MD Principal Investigator New York Medical College
Overall Contact

Last Name: Anneliese Rosdil, MSN

Phone: 3126081436

Email: [email protected]

Verification Date

March 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: rituximab

Type: Experimental

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

Acronym NYMC207
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov