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Multi center clinical study of the efficacy and safety of rhTPO in treatment of thrombocytopenia after chemotherapy for acute myeloid leukemia

Multi center clinical study of the efficacy and safety of rhTPO in treatment of thrombocytopenia after chemotherapy for acute myeloid leukemia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17011884
Enrollment
Unknown
Registered
2017-07-06
Start date
2013-04-16
Completion date
Unknown
Last updated
2017-07-10

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

Conditions

Acute myeloid leukemia

Interventions

Sponsors

Shandong provincial hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. No limit in gender and the patients aged 15 to 70 years; 2. Diagnosis of acute myeloid leukemia by bone marrow examination, flow cytometry and/or cytogenetic examination; 3. Patients achieve complete remission following induction chemotherapy and undergo consolidation therapy; 4. PLT count <50x10^9/L during the previous cycle of chemotherapy; 5. ECOG performance status of <=2 at study entry; 6. With normal liver and renal function(BUN is less than or equal to 1.5 times of the benchmark value,Creatinine is less than or equal to 1.5 times of the benchmark value, SGPT/ALT is less than or equal to 1.5 times of the benchmark value,Bilirubin is less than or equal to 1.5 times of the benchmark value); 7. Patients without severe heart or lung dysfunctions; 8. No history of mental illness; 9. The estimated survival is over 12 weeks; 10. Understand and voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with a medical history of severe allergy to biological agents; 2. Patients with a recent medical history of thrombosis; 3. Patients with thromboembolic or hemorrhagic disease; 4. Patients with M3 or M7 subtype; 5. Patients with a platelet count of >300x10^9/L at the start of consolidation therapy; 6. Pregnant or lactating patients, or patients with failure in use of contraception during the study period; 7. Other situations not approved by researchers.

Design outcomes

Primary

MeasureTime frame
platelet count;

Secondary

MeasureTime frame
lasting time of thrombocytopenia;quantity of platelet transfusion;Safety;

Countries

China

Contacts

Public ContactWang Xin

Shandong provincial hospital

xinw007@126.com+86 13156012606

Outcome results

None listed

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