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Evaluation and Comparison between Subcutaneous and Intravenous Injection of Granulocyte-Colony Stimulating Factor for Mobilization of Stem Cells in Autologous Hematopoietic Stem Cells Transplant Recipients

Evaluation and Comparison between Subcutaneous and Intravenous Injection of Granulocyte-Colony Stimulating Factor for Mobilization of Stem Cells in Autologous Hematopoietic Stem Cells Transplant Recipients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100127003210N29
Enrollment
64
Registered
2024-12-06
Start date
2025-01-04
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with various Blood Malignancies who are candidates for Autologous Hematopoietic Stem Cell Transplantation.. Stem cells transplant status

Interventions

Intervention 1: Intervention group: G-CSF from Neopogen® brand manufactured by Amgen company will be taken Subcutaneously starting from the first day of mobilization for 5 days. The drug dose is deter

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients aged between18 -70 years old who are candidates for autologous bone marrow stem cell transplantation Informed consent to enter the study No pregnanct and lactation Minimum interval of 4 weeks between the last cycle of chemotherapy and entering the study Serum creatinine = 2.2 mg/dL Liver function test (AST, ALT) below three times the upper limit normal

Exclusion criteria

Exclusion criteria: History of allergy to G-CSF Receiving Filgrastim or Peg-filgrastim during 2 and 3 weeks before entering the study, respectively

Design outcomes

Primary

MeasureTime frame
CD34 count. Timepoint: daily. Method of measurement: Flow cytometry.

Secondary

MeasureTime frame
Incidence of side effects of headache, bone pain, muscle pain, flu-like symptoms, and fatigue. Timepoint: daily. Method of measurement: Clinical observation during daily visits.;Engraftment time. Timepoint: daily. Method of measurement: Measuring Blood cells count.;Incidence of febrile neutropenia. Timepoint: daily. Method of measurement: Measuring blood cell counts and body temperature.;Incidence of thrombocytopenia. Timepoint: daily. Method of measurement: Measuring blood cell counts.;Incidence of documented infection. Timepoint: daily. Method of measurement: Clinical sign and symptoms and laboratory data.;The need to plerixafor injection. Timepoint: During mobilization. Method of measurement: Registering and reporting the number of patients who need to be prescribed Plerixafor in each study group.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaria Tavakoli Ardakani

Shahid Beheshti University of Medical Sciences

mariatavakoli@sbmu.ac.ir+98 21 8887 3704

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026