A single dose of pegfilgrastim compared with daily filgrastim for supporting neutrophil recovery in patients with acute myeloid leukemia after chemotherapy
Determination of the Short-acting G-CSF Method and Long acting PEG_GCSF method on the neutrophils count in patients after chemotherapy and there complications
Design
In a clinical trial, patients were assigned to study groups using randomized six-block. The person who evaluated outcomes was not aware from the type of intervention.
Settings and conduct
This study was conducted at Kowsar Hospital, an academic hospital affiliated with the Semnan University of Medical Sciences and Health Services.
Participants/Inclusion and exclusion criteria
All patients between 15 to 65 years old with Acute myeloid leukemia who have received induction chemotherapy and went to remission enrolled in study after receiving high dose cytarabine and if patients have sepsis, excluded from study.
Intervention groups
Patients received a course induction chemotherapy (idarubicin 12 mg/m2 days 1–3, cytarabine 100 mg/m2 twice daily days 1–7). If complete remission was achieved, patients received one course of high-dose cytarabine consolidation therapy (3 g/m2 if aged <55 years, 2 g/m2 if aged ≥ 55 years). Then patients were randomly assigned to receive either tow intervention groups. In the first group, Filgrastim 5 μg/kg SC was administered daily beginning 24 hours after chemotherapy. In the second group Pegfilgrastim was administered as a single SC 6-mg dose approximately 24 hours after completing chemotherapy. Then complete blood cell count and differential and peripheral blood smear were performed for all patients and patients evaluated for outcomes and complications for up to 21 days.
Main outcome variables
Increasing of Neutrophil count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151020024625N8
Registration date:2018-06-30, 1397/04/09
Registration timing:retrospective
Last update:2018-06-30, 1397/04/09
Update count:0
Registration date
2018-06-30, 1397/04/09
Registrant information
Name
Mehrdad Zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7844
Email address
mehrdadzahmatkesh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
2017-01-20, 1395/11/01
Actual recruitment end date
2018-04-20, 1397/01/31
Trial completion date
empty
Scientific title
A single dose of pegfilgrastim compared with daily filgrastim for supporting neutrophil recovery in patients with acute myeloid leukemia after chemotherapy
Public title
Pegfilgrastim compared with filgrastim in patients with acute myeloid leukemia after chemotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who went to remission after induction chemotherapy.
Exclusion criteria:
Non remission
Sepsis during or after chemotherapy
History of hypersensitivity reactions to E. coli-derived proteins and other drugs
Age
From 15 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
58
Actual sample size reached:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by six block randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who evaluate outcome is unaware from type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2015-10-06, 1394/07/14
Ethics committee reference number
IR.SEMUMS.REC.1394.93
Health conditions studied
1
Description of health condition studied
Neutropenia
ICD-10 code
D72
ICD-10 code description
Other disorders of white blood cells
Primary outcomes
1
Description
Neutrophil count
Timepoint
Daily< up to 21 days after intervention
Method of measurement
Complete blood cell count and peripheral blood smear
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients received one or two course induction chemotherapy (idarubicin 12 mg/m2 days 1–3, cytarabine 100 mg/m2 twice daily days 1–7). If complete remission was achieved, patients received one course of high-dose cytarabine consolidation therapy (3 g/m2 if aged <55 years, 2 g/m2 if aged ≥ 55 years). Then, Filgrastim 5 μg/kg SC was administered daily beginning 24 hours after chemotherapy. Then complete blood cell count and differential and peripheral blood smear were performed for all patients and patients evaluated for outcomes and complications for up to 21 days.
Category
Treatment - Other
2
Description
Intervention group: Patients received a course induction chemotherapy (idarubicin 12 mg/m2 days 1–3, cytarabine 100 mg/m2 twice daily days 1–7). If complete remission was achieved, patients received one course of high-dose cytarabine consolidation therapy (3 g/m2 if aged <55 years, 2 g/m2 if aged ≥ 55 years). Then, Pegfilgrastim was administered as a single SC 6-mg dose approximately 24 hours after completing chemotherapy. Then complete blood cell count and differential and peripheral blood smear were performed for all patients and patients evaluated for outcomes and complications for up to 21 days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital, affiliated to Semnan Universities of Medical Sciences
Full name of responsible person
Farahnaz Ghahremanfard MD
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
f_ghahremnafard@yahoo.ccm
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Reza Asgari
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
sem.ums.res@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Farahnaz Ghahremanfard MD
Position
Associte professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
f_ghahremanfard@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Farahnaz Ghahremanfard MD
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
f_ghahremanfard@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Research Expert
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2252
Email
mehrdadzahmatkesh@semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data will publish as final report.
When the data will become available and for how long
َAfter completing
To whom data/document is available
Researchers and Physicians
Under which criteria data/document could be used
For similar studies and clinical use
From where data/document is obtainable
Scientific responsible, Farahnaz Ghahremanfard MD
What processes are involved for a request to access data/document