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The effect of long-acting subcutaneous drug in increasing white blood cells in patients with leukemia after chemotherapy

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015072623349N1
Enrollment
58
Registered
2016-01-19
Start date
2015-07-23
Completion date
Unknown
Last updated
2022-08-29

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

Conditions

Acute Meyeloid Lukemia. C81-C96 Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue - C92.0Acute myeloblastic leukaemia [AML]

Interventions

Intervention 1: Intervention group patients after receiving one or two courses of induction chemotherapy (cytarabine+daunorubicin) and after achieving complete remission, are treated with high dose ar

Sponsors

Pooyesh Darou Biopharmaceutical Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 65 Years

Inclusion criteria

Inclusion criteria: Denovo AML Age 15-65 Achieved complete remission after induction chemotherapy Received high dose of Cytarabine in consolidation chemotherapy

Exclusion criteria

Exclusion criteria: Secondary AML ECOG performance status=3 Have any effective disease (such as cardiovascular disease, renal disease, liver disease, pulmonary disease, diabetes, high blood pressure etc.) or receiving drugs and continuous treatment

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
The effect of PD-Lasta in reducing the incidence of infection after chemotherapy. Timepoint: From day 14 after chemotherapy. Method of measurement: Clinical evaluation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Mohsen Esfandbod

Tehran University of Medical Sciences

sfandbod@sina.tums.ac.ir+98 21 81631

Outcome results

None listed

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