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Evaluation of the efficacy and safety of single-dose PEG-rhG-CSF, cytarabine and aclaramycin regimens for relapse or refractory acute myeloid leukemia

Evaluation of the efficacy and safety of single-dose PEG-rhG-CSF, cytarabine and aclaramycin regimens for relapse or refractory acute myeloid leukemia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17012015
Enrollment
Unknown
Registered
2017-05-31
Start date
2017-11-01
Completion date
Unknown
Last updated
2017-11-27

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

Conditions

acute myeloid leukemia

Interventions

Test group:cytarabine: 10mg/m2, q12h, D1-14
aclaramycin: 14mg/ m2/d, D1-4
Peg-rhG-CSF: Body weight (BW) =45kg, 6mg, BW<45kg, 3mg, D0
Control:cytarabine: 10mg/m2, q12h, D1-14
rhG-CSF: 200µg/m2/d, D0-14

Sponsors

Xinqiao Hospital, Chongqing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-60 years old male and female; (2) Confirmed relapse or refractory acute myeloid leukemia patients; (3) ECOG score =2; (4) Expected to survive more than 3 months; (5) Liver function tests: ALT, AST, TBIL are within 2.5 times the upper limit of normal, if due to liver metastasis, the above indicators should be within 5 times the upper limit of normal; (6) Renal function tests: BUN, Cr, UA within 1.5 times the upper limit of normal; (7) Patients can tolerate chemotherapy; (8) Patients participate in this trial voluntarily and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Acute promyelocytic leukemia, Blastocysts of chronic myeloid leukemia, MDS-transformed AML; (2) Had undergone allogeneic hematopoietic stem cell transplantation before the first relapse; (3) Had previously received CAG(cytarabine, aclaramycin and rhG-CSF ) regimen; (4) WBC=20×10^9/L; (5)Have severe heart, lung, liver, kidney dysfunction; (6) Allergies, or allergies to any drug in this program; (7) Suffering from other tumor to be treated; (8) Severe mental or neurological disorders that affect informed consent and / or adverse expression or observation; (9) Female pregnancy or breastfeeding; women of childbearing age who refuse to accept contraception; (10) Patients who were judged by the investigator as not suitable for the study.

Design outcomes

Secondary

MeasureTime frame
Neutrophil recovery time in Induction chemotherapy stage;The incidence of infection in Induction chemotherapy stage;2 years overall survival;2-year progression free survival;—

Primary

MeasureTime frame
The complete remission rate of induction chemotherapy;—

Contacts

Public ContactXi Zhang

Xinqiao Hospital, Chongqing

zhangxxi@sina.com+86 13808310064

Outcome results

None listed

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