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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: Clinical Trial Phase 3 study, sponsored by Barbara Ann Karmanos Cancer Institute.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time in days until absolute neutrophil count (ANC) recovery to greater than or equal to 1,000/uL from the start of chemotherapy
Interventions
- BIOLOGICAL filgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2013-08 |
| Est. Completion | 2018-06 |
| Phase | Phase 3 |
Why NCT01987596 stopped before completion
NCT01987596 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which filgrastim is the first listed.
NCT01987596 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01987596's enrollment target sits among peer trials
23 1952nd of 2000 higher than 48 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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