The clinical study of Pre-chemotherapy recombinant human thrombopoietin to reduce chemotherapy-induced thrombocytopenia of acute myeloid leukemia patients

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100041866

Enrollment

Unknown

Registered

2021-01-08

Start date

2021-01-11

Completion date

Unknown

Last updated

2021-03-30

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

Conditions

Acute myeloid leukemia

Interventions

Group A:pre-chemo TPO in the first cycle of two intensive chemotherapy

Group B:pre-chemo TPO in the second cycle of two intensive chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Aged >= 14 years old, and gender is not limited. (2) Acute myeloid leukemia patients. (3) Complete remission achieved after the first 1-2 induction therapies. (4) Multiple (>= 2) times of medium-large dose cytarabine intensive chemotherapies will be administered. (5) The ECOG score is 0-2. (6) The patients agree to participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: The subject should be excluded if any criterion listed below is met. (1) The central nervous system is involved. (2) a medical history of severe heart disease, including ventricular tachycardia, atrial fibrillation, cardiac block, myocardial infarction within one year, congestive heart failure and coronary heart disease with symptoms requiring medications. (3) renal insufficiency ( serum creatinine >180µmol/L) and/or liver insufficiency (total bilirubin > 34 µmol/L, ALT/AST > 3 times above the upper limit of normal). (4) the cycles of chemotherapy before inclusion in this study are more than 3 (excluding 3),or other targeted drugs (such as sorafenib, imatinib, etc.) need to be administered together with cytarabine. (5) participation in any other clinical trial within the last one month. (6) the participation is considered not suitable by the researchers.

Design outcomes

Primary

Measure	Time frame
The lowest value of platelet;Duration of platelet low than 5010^9/L;Duration of platelet lower than 2010^9/L;	—

Secondary

Measure	Time frame
Overall survival;Relapse-free survival;Relapse rate;	—

Countries

China

Contacts

Public ContactQingsheng Li

Department of Hematology, the First Affiliated Hospital of Anhui Medical University

wshsyh604@163.com+86 13485604387

Outcome results

None listed

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