Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Early Phase 1 study of Ewing's Sarcoma and Chemotherapy Induced Thrombocytopenia, sponsored by Children's Hospital Medical Center, Cincinnati.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
CIT is defined as 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 (beyond cycle 6)
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 |
What NCT07048249 shows while recruiting
NCT07048249 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 83-participant average among 7 other Ewing's Sarcoma trials with a reported enrollment target (69% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Ewing's Sarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Assessment of Healing and Function After Reconstruction Surgery for Bone Sarcomas
RECRUITING
-
Aflac ST0901 CHOANOME - Sirolimus in Solid Tumors
COMPLETED · Phase 1
-
A Pilot Study of Tumor-Specific Peptide Vaccination and IL-2 With or Without Autologous T Cell Transplantation in Recurrent Pediatric Sarcomas
COMPLETED · Phase 2
-
New Therapeutic Strategies for Patients With Ewing's Sarcoma Family of Tumors, High Risk Rhabdomyosarcoma, and Neuroblastoma
COMPLETED · Phase 2
-
A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's Sarcoma
COMPLETED · Phase 2
-
Trial of Bi-shRNA-furin and GMCSF Augmented Autologous Tumor Cell Vaccine for Advanced Cancer
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02646475 · 26 participants · Phase 1
Metabolic Effects of Angiotensin-(1-7)
- NCT03603223 · 26 participants · Phase 2
Pembrolizumab in Treating Participants With Leukoplakia
- NCT04063592 · 26 participants · NA
AMI Construction in Lower Extremity Residual Limbs
- NCT04906460 · 26 participants · Phase 1
Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI