SubCutaneous (SC) Versus Intravenous (IV) Granulocyte Colony Stimulating Factors (G-CSF) for the Treatment of Neutropenia in Hospitalized Haemato-oncological Patients

NCT01222819 | Terminated Phase 4 DMC

• 1 other identifier: 5981
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Leukemia

Keywords

Febrile neutropenia; growth factors; leukemia

Outcome Measures

Primary Outcomes (2)

• Primary efficacy outcome

  Time to stable neutrophil recovery, defined as the number of days from start of filgrastim (day 1) until the neutrophil count has reached \>500/mcL for 3 consecutive days

  30 days

• Primary safety outcome

  30-day mortality or documented infection (CDI, MDI, bacteremia or probable/ proven IFI, see definitions below) within the chemotherapy course (before or after neutrophil recovery).

  30

Secondary Outcomes (2)

• Will include rates of infection, fever days, hospital stay.

  In-hospital

• Will include patient's satisfaction, other clinical endpoints and adverse events

  30 days

Study Arms (2)

IV filgrastim

EXPERIMENTAL

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.

Drug: filgrastim

SC filgrastim

ACTIVE COMPARATOR

given as a single daily dose of 5 mcg/kg (rounded to 300 mcg or 480 mcg)

Drug: filgrastim

Interventions

filgrastim DRUG

5 mcg/kg (rounded to 300 mcg or 480 mcg)

Also known as: Neupogen

IV filgrastim; SC filgrastim

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• The investigators will exclude patients receiving CSFs for their primary disease (e.g. aplastic anemia, myelodysplastic syndromes) and pregnant women.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center; Beilinson Hospital and Davidoff Cancer Center

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Leukemia; Febrile Neutropenia

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Mical Paul, M.D.

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

• Pia Raanani, M.D.

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 18, 2010
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

IL (1)