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NCT07048249 · ClinicalTrials.gov registry record · Early Phase 1
Single Arm Romiplostim to Prevent CIT
A Early Phase 1 study of Ewing's Sarcoma and Chemotherapy Induced Thrombocytopenia, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 26
- Enrollment target
- 2
- Study locations
NCT07048249 is a Early Phase 1 study of Ewing's Sarcoma and Chemotherapy Induced Thrombocytopenia that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 26 participants, below the 83-participant average among 7 other Ewing's Sarcoma trials with a reported enrollment target (69% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT07048249, a Early Phase 1 study of Ewing's Sarcoma and Chemotherapy Induced Thrombocytopenia, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 26 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this clinical trial is to to assess the efficacy of romiplostim as a supportive care measure in patients with a new diagnosis of Ewing sarcoma receiving interval-compressed chemotherapy. The main questions it aims to answer are: 1. To demonstrate the efficacy of romiplostim in patients with newly diagnosed Ewing sarcoma, measured specifically as the rate of CIT, defined as a failure to achieve platelet recovery (≥ 75,000/µL post nadir, without transfusion, or a platelet count sufficient to resume chemotherapy per provider and institutional standard) within 7 days of planned chemotherapy cycle start, measured during the continuation phase (cycle 7 to end of cycle 13 or 16, per AEWS0031/AEWS1221, or AEWS1031 respectively) of interval-compressed chemotherapy (every 2 week vincristine/cyclophosphamide +/- doxorubicin and ifosfamide/etoposide chemotherapy) as compared to published institutional historical control rate. 2. To determine the safety of incorporation of romiplostim supportive care when given concurrently with Ewing sarcoma therapy. 3. To determine the feasibility of incorporation of romiplostim supportive care into upfront Ewing sarcoma regimens.
Conditions Studied
Interventions
- DRUG Romiplostim (AMG-531)
Study Locations (2)
Arizona
- Phoenix Children's - Phoenix
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2024-01-26 |
| Est. Completion | 2028-01-01 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07048249
The ClinicalTrials.gov registry entry for NCT07048249 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 83-participant average among 7 other Ewing's Sarcoma trials with a reported enrollment target (69% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Ewing's Sarcoma appearing as the primary indexed condition, and to 1 intervention - of which Romiplostim (AMG-531) is the first listed.
NCT07048249 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Arizona, Ohio.
Frequently Asked Questions
What is clinical trial NCT07048249 about?
NCT07048249 is a clinical study titled "Single Arm Romiplostim to Prevent CIT". The goal of this clinical trial is to to assess the efficacy of romiplostim as a supportive care measure in patients with a new diagnosis of Ewing sarcoma receiving interval-compressed chemotherapy. The main questions it aims to answer are: 1. To demonstrate the efficacy of romiplostim in patients ...
What is the current status of trial NCT07048249?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 26 participants. The study started on 2024-01-26. Estimated completion is 2028-01-01.
What conditions does trial NCT07048249 study?
This clinical trial studies the following conditions: Ewing's Sarcoma, Chemotherapy Induced Thrombocytopenia.
What interventions are being tested in trial NCT07048249?
The interventions under investigation include: Romiplostim (AMG-531) (DRUG).
Who is sponsoring clinical trial NCT07048249?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07048249 being conducted?
This trial has 2 study locations across Arizona, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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