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A prospective, multicentre, self-paired,cross-over design study of secondary prevention or treatment with rhTPO for CIT improvement in patients with AML who received high-dose cytarabine consolidation therapy

A prospective, multicentre, self-paired,cross-over design study of secondary prevention or treatment with rhTPO for CIT improvement in patients with AML who received high-dose cytarabine consolidation therapy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045289
Enrollment
Unknown
Registered
2021-04-10
Start date
2021-04-06
Completion date
Unknown
Last updated
2021-11-16

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:The first course: secondary prevention mode
The second course: treatment mode
group B:The first course: treatment mode
The second course: secondary prevention mode

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.Age range 14-60 years, gender unlimited; 2.AML (except M3, M7 and M6); 3.Cytological CR was achieved in the early 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.AML with a history of prodromal MDS or chronic leukemia, MPN sudden change; 2.The PLT count before rhTPO is greater than 300G/L; 3.Past thromboembolic diseases; 4.Combined with severe infection before treatment; 5.Allergy or intolerance to rhTPO; 6.Merge other tumors; 7.The researcher believes that there are any other circumstances that may prevent the subject from completing the study or bring obvious risks to the subject.

Design outcomes

Primary

MeasureTime frame
Duration of Grade III of CIT;Duration of Grade IV of CIT;

Secondary

MeasureTime frame
The incidence of different grades of CIT;Duration from the first time when PLT was below 20G/L to the time when it recovered to 20G/L, 30G/L, and above 50G/L;Time of CIT occurrence;Number of platelet transfusions;The total amount of rhTPO per treatment course;Safety;

Countries

China

Contacts

Public ContactWang Yadan

Wuhan Union Hospital

hillaryw@163.com+86 13886009408

Outcome results

None listed

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