At a glance
ClinicalIndex Comparison RecordPhase 1Recruiting· 20 target
Drug / intervention
rituxandrug
Likely dose
rituxan 375 mg/m2from record
Key inclusion· 7
- ✓Age 1-21 years
- ✓Newly diagnosed ITP with platelet count ≤20 x 10^9/L
- ✓Bone marrow aspirate and biopsy to rule out malignancy
- ✓At least one high-risk criterion: age ≥10 years, Grade II-IV bleeding, ANA positivity, or no preceding infection within 2 weeks
Key exclusion· 6
- ✕History of Grade III-IV allergic reaction to rituximab
- ✕Bone marrow neoplastic infiltration
- ✕History of hepatitis B infection
- ✕Pregnancy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Use of Dose Dense Rituximab for High Risk Patients With Newly Diagnosed Acute Immune Thrombocytopenic Purpura
In Brief
A Phase 1 clinical trial evaluating rituxan for Immune Thrombocytopenic Purpura. Currently recruiting, targeting 20 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmune Thrombocytopenic Purpura
CountriesUnited States
Collaborators--
Timeline
Phase 1Recruiting
2021202220232024202520262027
First PostedMar 2020
Enrollment StartFeb 2021
TodayJul 2026
Primary CompletionJul 2026
Study CompletionJul 2027
First PostedMar 26, 2020
Enrollment StartFeb 24, 2021
Primary CompletionJul 31, 2026
Study CompletionJul 31, 2027
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 6.3 years agoPrimary completion in 29 days
Interventions
rituxandrug
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