Clinical trial · Interventional
SubCutaneous (SC) Versus Intravenous (IV) Granulocyte Colony Stimulating Factors (G-CSF) for the Treatment of Neutropenia in Hospitalized Haemato-oncological Patients
Subcutaneous (SC) vs. Intravenous (IV) Granulocyte Colony Stimulating Factors (G-CSF) for the Treatment of Neutropenia in Hospitalized Haemato-oncological Patients: Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Physycians' refusal to continue the study
Summary
Brief summary (as posted)
Granulocyte colony stimulating factor (G-CSF) is frequently used among patients with cancer including those with haematological malignancies. Filgrastim is a recombinant human CSF whose biological activity is similar to that of endogenous G-CSF. In the treatment of chemotherapy-induced neutropenia in patients with various types of cancer CSFs significantly reduced the time to neutrophil recovery and length of hospitalization.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim | Drug | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IV filgrastim
- description
- as a single daily dose of 5 mcg/kg (rounded to 300 mcg or 480 mcg) in bolus IV injection, as per manufacturer's recommendations.
- interventionNames
- Drug: filgrastim
- type
- ACTIVE_COMPARATOR
- label
- SC filgrastim
- description
- given as a single daily dose of 5 mcg/kg (rounded to 300 mcg or 480 mcg)
- interventionNames
- Drug: filgrastim
Primary outcomes (2)
- measure
- Primary efficacy outcome
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients hospitalized in haemato-oncology ward starting filgrastim for the treatment of chemotherapy-induced neutropenia. * Will include patients with acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL), aggressive lymphoma or multiple myeloma. * Will include both patients with or without a documented infection at the time of CSF initiation. Initiation of filgrastim treatment will follow the 2006 ASCO guidelines (departmental routines). Exclusion Criteria: * The investigators will exclude patients receiving CSFs for their primary disease (e.g. aplastic anemia, myelodysplastic syndromes) and pregnant women.
References
Publications (0)
Data not yet available