Skip to content

Exploration of optimal timing of administration of rhTPO for secondary prevention of CIT in Mid/High-dose cytarabine consolidation therapy in AML patients: a prospective, randomized, self-controlled trial

Exploration of optimal timing of administration of rhTPO for secondary prevention of CIT in Mid/High-dose cytarabine consolidation therapy in AML patients: a prospective, randomized, self-controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044414
Enrollment
Unknown
Registered
2021-03-18
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-09-20

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

Conditions

Acut Myloid Leukima

Interventions

Group A:Prophylaxis after chemotherapy
Group B:Prophylaxis before chemotherapy

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Aged 14-60 years; 2) AML (except M3, M7 and M6); 3) Cytological CR was achieved in the induction therapy; 4) At least 2 courses of MID/HID-Ara-C containing chemotherapy are planned, and the type and dose of chemotherapy drugs must be the same for both courses; 5) No other platelet growth factors were used during the study period.

Exclusion criteria

Exclusion criteria: 1) A history of MDS or AML with chronic leukemia or MPN change; 2) PLT count before RHTPO is greater than 300G/L; 3) thromboembolic diseases history; 4) Severe infection before treatment; 5) Allergic or intolerant to rhTPO; 6) Complicated with other tumors; 7) The Investigator considers that there are any other conditions which may cause the subject to fail to complete the study or which may pose a significant risk to the subject.

Design outcomes

Primary

MeasureTime frame
The duration of the CIT III level;The duration of the CIT IV level;

Secondary

MeasureTime frame
The incidence of different grades of CIT;Duration from first PLT below 20G/L to recovery above 20G/L, 30G/L, and 50G/L;The time of CIT happened;Number of platelet transfusions;The total amount of RHTPO per treatment course;Safety: incidence and severity of adverse events, clinically significant abnormal laboratory test results;

Countries

China

Contacts

Public ContactYadan Wang

Wuhan Union Hospital West Campus

hillaryw@163.com+86 13886009408

Outcome results

None listed

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