The effectiveness of a single dose of peg-filgrastim (PD-Lasta) compared with Filgrastim (PD-grastim) to increase the absolute number of neutrophils (ANC) in patients with AML after chemotherapy
Objective: The purpose of this clinical trial is comparing the effect of peg-filgrastim (PD-Lasta) with filgrastim (PD-grastim) in increasing neutrophils in AML patients after chemotherapy. Design & Setting: 58 patients with AML after one or two courses of induction chemotherapy (cytarabine + daunorubicin) and after achieving remission, undergoes consolidation with high-dose cytarabine (4 courses). Patients are divided into two groups via Haphazard number table. The first group 24 hours after consolidation chemotherapy receive daily subcutaneous PD-grastim 5 μgr/kg dose and the second group 24 hours after consolidation chemotherapy receive a PD-Lasta 6mg dose. Then daily ANC (absolute neutrophil count) of the patients in two groups are recorded until reaching above 1500 per microlitre. Participants: All patients between 15 to 65 years old with AML who are in remission following induction chemotherapy after receiving high-dose cytarabine enter the trial and if any patient is suffering from sepsis is removed from the trial. Main outcome measures: The primary outcome: The effect of PD-Lasta usage in increasing patients ANC above 1500/ul. Secondary outcomes: The effect of PD-Lasta usage in reducing the incidence of infection after chemotherapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072623349N1
Registration date:2016-01-19, 1394/10/29
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-01-19, 1394/10/29
Registrant information
Name
Mohsen Esfandbod
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 982 181 631
Email address
sfandbod@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pooyesh Darou Biopharmaceutical Company
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of a single dose of peg-filgrastim (PD-Lasta) compared with Filgrastim (PD-grastim) to increase the absolute number of neutrophils (ANC) in patients with AML after chemotherapy
Public title
The effect of long-acting subcutaneous drug in increasing white blood cells in patients with leukemia after chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: All patients aged 15 to 65 years with acute myeloid leukemia Who are in remission after induction chemotherapy and were under consolidation chemotherapy with HI-DAC regime. Exclusion criteria: failure to achieve remission, unsuitable for HI-DAC regime, septicemia.
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Haphazard number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, Cornre of the Ghods Street
City
Tehran
Postal code
1417653761
Approval date
2015-08-03, 1394/05/12
Ethics committee reference number
27325
Health conditions studied
1
Description of health condition studied
Acute Meyeloid Lukemia
ICD-10 code
C81-C96 -
ICD-10 code description
C81-C96 Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue - C92.0Acute myeloblastic leukaemia [AML]
Primary outcomes
1
Description
The time of reaching ANC above 1500/ul by using PD-lasta
Timepoint
Patient daily absolute neutrophil count (ANC) record until ANC reaches above 1500 per microlitre
Method of measurement
Colter
Secondary outcomes
1
Description
The effect of PD-Lasta in reducing the incidence of infection after chemotherapy
Timepoint
From day 14 after chemotherapy
Method of measurement
Clinical evaluation
Intervention groups
1
Description
Intervention group patients after receiving one or two courses of induction chemotherapy (cytarabine+daunorubicin) and after achieving complete remission, are treated with high dose ara-c (2 to 4 cycle). After 24 hour of chemotherapy, patients receive a single long-acting subcutaneous GCSF (PD-lasta).
Category
Treatment - Drugs
2
Description
Control group patients after receiving one or two courses of induction chemotherapy (cytarabine+daunorubicin) and after achieving complete remission, are treated with high dose ara-c (2 to 4 cycle). After 24 hour of chemotherapy patients receive daily short-acting GCSF (PD-filgrastim).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology Oncology ward of Valiasr Hospital, Imama Khomeini Hospital Complex
Full name of responsible person
Dr Mohsen Esfandbod
Street address
Valiasr Hospital of Imam Khomeini hospital complex, Gharib Street, End of the Keshavarz Boulevard
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pooyesh Darou Biopharmaceutical Company
Full name of responsible person
Shima Tanha
Street address
No.13, 5th Ave, Fatemi St, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pooyesh Darou Biopharmaceutical Company
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohsen Esfandbod
Position
Adult clinical Hematology Oncology/ Assistant Professor
Other areas of specialty/work
Street address
Keshavarz Boulevard, Cornre of the Ghods Street
City
Tehran
Postal code
1417653761
Phone
+98 21 81631
Fax
+98 21 8898 9664
Email
sfandbod@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Gholamreza Toogeh
Position
Adult clinical Hematology Oncology/ Associate Professor
Other areas of specialty/work
Street address
Keshavarz Boulevard, Cornre of the Ghods Street
City
Tehran
Postal code
1417653761
Phone
+98 21 81631
Fax
+98 21 8898 9664
Email
gh_toogeh@yahoo.com; togehgho@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Zarrabi
Position
Research Administrate at Thrombosis Hemostasis Research Center/ MSc in Genetics
Other areas of specialty/work
Street address
Keshavarz Boulevard, Cornre of the Ghods Street
City
Tehran
Postal code
1417653761
Phone
+98 21 81631
Fax
+98 21 8898 9664
Email
fariba_zarrabi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)