A single-center, randomized, clinical study of a single dose of peg-rhG-CSF compared with daily rhG-CSF for supporting neutrophil recovery in acute myeloid leukemia patients.

A single-center, randomized, clinical study of a single dose of peg-rhG-CSF compared with daily rhG-CSF for supporting neutrophil recovery in acute myeloid leukemia patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-14004836

Enrollment

Unknown

Registered

2014-06-22

Start date

2014-06-22

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

acute myeloid leukemia

Interventions

peg-rhG-CSF:peg-rhG-CSF

rhG-CSF:rhG-CSF

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. bone marrow morphology, immunology, molecular biology and cytology diagnosed AML( non-APL) patients. classification as follows; non-APL AML in FAB classification; AML with recurrent cytological abnormalities (non-APL) in WHO classification; AML with multiple dyshaematopoiesis, but with no MDS/MPN history; acute panmyelosis with myelofibrosis and myeloid sarcoma in WHO Classification; 2. =55, =18, female and male;3. expected survival longer than 40 days;4. laboratory examination: (within 7 days before drug admission); i. TBIL = 1.5 normal value (at the same age);ii. AST/ALT = 2.5 normal value (at the same age);iii. serum creatinine <2 normal value (at the same age);iv. myocardial enzymes <2 normal value (at the same age);5. standard dosage HAD induction chemotherapy;6. ECOG =2 points;7. signed informed consent before trials;patients <18 should obtain signed informed consent from himself/herself and immediate families?.

Exclusion criteria

Exclusion criteria: Exclusion criteria 1) relapse patients (AML patients who achieved CR, bone marrow indicate relapse this time); 2)acute panmyelosis with myelofibrosis and myeloid sarcoma in WHO Classification; 3) companied with other tumor which needs treatment; 4) allergy or intolerant to PEG-rhG-CSF or G-CSF; 5) abnormal liver or kidney function; 6) drug abuse, medical, psychological or social conditions could affect subjects participate the study or the results evaluation; 7) active infection or fever; 8) pregnant and lactate female patients; childbearing age female patients who refused to accept the contraceptive measures; 9) taking other trial drugs or participate in other clinic trials in the last three months; 10) researchers consider unsuitable for the trial.

Design outcomes

Primary

Measure	Time frame
Days of neutrophil recover;	—

Secondary

Measure	Time frame
infection rate;admision tim;	—

Countries

China

Contacts

Public ContactKaiqi Liu

Institute of Hematology &Blood Disease Hospital, Chinese Academy of Medical Sciences

yanghua94583@sina.com+86 13602127632

Outcome results

None listed

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