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NCT01987596 · ClinicalTrials.gov registry record · Phase 3
Study of Fixed vs. Flexible Filgrastim to Accelerate Bone Marrow Recovery After Chemotherapy in Children With Cancer
A Phase 3 study, sponsored by Barbara Ann Karmanos Cancer Institute.
- Terminated
- Registry status
- Phase 3
- Development phase
- 23
- Enrollment target
NCT01987596 is a Phase 3 study that was terminated before completion, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 23 participants.
The verdict
NCT01987596, a Phase 3 study, was terminated before completion, sponsored by Barbara Ann Karmanos Cancer Institute.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 23 participants
- Enrollment target
Study Summary
This randomized phase III trial studies flexible administration of filgrastim after combination chemotherapy to see how well it works compared to fixed administration of filgrastim in decreasing side effects of chemotherapy in younger patients with cancer. Cancer chemotherapy frequently results in neutropenia (low blood counts) when patients are susceptible to severe infections. A medicine called G-CSF (filgrastim) stimulates bone marrow and daily filgrastim shots are commonly used to shorten neutropenic periods and decrease infections after chemotherapy. Since filgrastim is customarily used on a fixed schedule starting early after chemotherapy and there are data that early doses may not be needed, this study tests new flexible schedule of filgrastim to optimize its use by reducing the number of painful shots, cost of treatment, and filgrastim side effects in children with cancer receiving chemotherapy.
Interventions
- BIOLOGICAL filgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2013-08 |
| Est. Completion | 2018-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01987596
The ClinicalTrials.gov registry entry for NCT01987596 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Barbara Ann Karmanos Cancer Institute, which has 139 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which filgrastim is the first listed.
NCT01987596 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01987596 about?
NCT01987596 is a clinical study titled "Study of Fixed vs. Flexible Filgrastim to Accelerate Bone Marrow Recovery After Chemotherapy in Children With Cancer". This randomized phase III trial studies flexible administration of filgrastim after combination chemotherapy to see how well it works compared to fixed administration of filgrastim in decreasing side effects of chemotherapy in younger patients with cancer. Cancer chemotherapy frequently results in n...
What is the current status of trial NCT01987596?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 23 participants. The study started on 2013-08. Estimated completion is 2018-06.
What interventions are being tested in trial NCT01987596?
The interventions under investigation include: filgrastim (BIOLOGICAL).
Who is sponsoring clinical trial NCT01987596?
This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.
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