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A prospective, multicenter, randomized, controlled clinical trial of Herombopag Olamine Tablets in the prevention of thrombocytopenia in children with acute lymphoblastic leukemia during myelosuppression

A prospective, multicenter, randomized, controlled clinical trial of Herombopag Olamine Tablets in the prevention of thrombocytopenia in children with acute lymphoblastic leukemia during myelosuppression

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093681
Enrollment
Unknown
Registered
2024-12-10
Start date
2023-12-14
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

acute lymphoblastic leukemia

Interventions

Experimental Group:Oral Herombopag Olamine Tablets was started 1 day after the second dose of vincristine was started in the CAT+ course
Control group:The course of CAT+ was completed as planned, and no platelet elevating drugs were used for observation only

Sponsors

Affiliated Hospital of Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.The patient met the diagnostic criteria for childhood acute lymphoblastic leukemia; 2.3 years old to less than 18 years old; 3.Patients with PLT > 100×10^9/L were required to complete the CAT+ phase treatment using CCCG-ALL2020 protocol; 4.The predicted survival time was >=3 months; 5.They voluntarily participated in this study, signed informed consent, and cooperated with follow-up.

Exclusion criteria

Exclusion criteria: 1. During the screening period, the levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were greater than 3 times the upper limit of normal values, and the levels of total bilirubin and serum creatinine were greater than 1.5 times the upper limit of normal values; 2. History of cirrhosis or portal hypertension; 3. The presence of congestive heart failure, arrhythmia, or peripheral arteriovenous thrombosis requiring medical treatment at enrollment or myocardial or cerebral infarction within 3 months before enrollment; 4. Before CAT+, oral administration of chemotherapy drugs (non-powdered) was difficult; 5. Previous allergy to the drug Haiqupopa ethanolamine; 6. Failure to complete 80% of cytarabine and mercaptopurine for various reasons (patients with definite NUDT15 or TPMT homozygous deficiency should reduce the dose of mercaptopurine by 50% before completing the dose) Other conditions considered by the investigator to be ineligible for inclusion

Design outcomes

Secondary

MeasureTime frame
Platelet transfusion volume;Minimal residual disease in bone marrow;Blood cell analysis;Coagulation function;Bleeding condition;Use of thrombopoietic drugs;

Primary

MeasureTime frame
Blood platelets;

Countries

China

Contacts

Public ContactJin Jiao

Affiliated Hospital of Guizhou Medical University

jinjiao999@163.com+86 151 8080 2411

Outcome results

None listed

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