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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.

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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

FieldValue
Enrollment Target 23 participants
Start Date 2013-08
Est. Completion 2018-06
Phase Phase 3

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.