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Rapid Administration Pilot for Infusing Dinutuximab

Study acronym: RAPID
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 9 months later Jan 2026 → Nov 2028
Primary endpoint added 2 → 3 primary endpoints
See other at-risk trials from Children's Hospital Los Angeles

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jan 2026 to Nov 2028 Show 10 more changesShow less
    • Primary endpoint(s) modified
    • Phase changed: Phase 1 → Phase 2
    • Enrollment increased: 11 → 30 participants
    • Lead sponsor: Children's Hospital Los Angeles to Children's Hospital Los Angeles
    • Trial sites expanded: 1 → 7 locations
    • Study completion pushed from Jan 2026 to Nov 2029
    • Eligibility criteria expanded, about 55 words
    • Secondary endpoints: 2 to 3
    • Study description expanded, about 16 words
    • Publications: details revised at 6 of 6 entries
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Dec 2025 to Jan 2026
    • Eligibility criteria shortened, about 18 words
    • Site details revised
    v5
  3. Phase: Phase 4 to Phase 1v4 Show 4 more changesShow less
    • Trial status: Suspended to Recruiting
    • Primary and study completion dates: Jun 2025 to Dec 2025
    • Eligibility criteria expanded, about 20 words
    • Site details revised
  4. Trial status: Recruiting to Suspended Sponsor's reason: Pending submission and approval of Amendment to IRB
    • Primary and study completion dates: Aug 2024 to Jun 2025
    • Start date: Oct 24, 2022 to Nov 29, 2022
    • Site details revised
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2022 to Oct 24, 2022
    • Site details revised
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Dinutuximab is an immunotherapy that has greatly improved outcomes for children with high-risk neuroblastoma and is now a standard part of treatment for both newly diagnosed and relapsed disease. However, the medication is typically given through an intravenous (IV) infusion over 10-20 hours a day for four consecutive days, requiring prolonged hospital stays that place a significant burden on children, families, and healthcare resources. Earlier studies of dinutuximab, as well as experience with a similar immunotherapy, suggest that these medications can be safely given over a much shorter period of time. This study is evaluating whether children with high-risk neuroblastoma can safely receive dinutuximab over five hours or less. Early results have been encouraging. The first group of patients successfully received most treatments with dinutuximab in about two hours. Children experienced very low pain levels and required approximately 78% less opioid pain medication compared with the traditional longer infusion. Several patients were able to receive treatment as outpatients without requiring hospital admission, while hospitalizations that did occur were primarily related to chemotherapy or other non-medical reasons rather than the rapid infusion itself. The study is now expanded to further evaluate the safety of rapid infusion across multiple treatment cycles at different centers in the United States. Researchers will also examine how the drug is processed by the body, whether the immune system develops antibodies against the treatment, and whether the faster infusion continues to reduce the need for opioid pain medication. In addition, children and their caregivers will complete questionnaires about symptoms and treatment experiences to better understand the impact of the faster dinutuximab infusion on quality of life and the overall treatment experience.
Trial Details
NCT Number NCT05421897
Lead Sponsor Children's Hospital Los Angeles
Collaborators: United Therapeutics
Conditions
(from sponsor)		 Neuroblastoma
Related terms Neoplasms, Neuroblastoma
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov