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A Prospective Observational Clinical Study of Recombinant Human Thrombopoietin for the Prevention of Thrombocytopenia After Chemotherapy in Children with Acute Lymphoblastic Leukemia

A Prospective Observational Clinical Study of Recombinant Human Thrombopoietin for the Prevention of Thrombocytopenia After Chemotherapy in Children with Acute Lymphoblastic Leukemia

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129299
Enrollment
Unknown
Registered
2026-08-03
Start date
2026-08-25
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

acute lymphoblastic leukemia

Interventions

Test group:None

Sponsors

Baoding Hospital of Beijing Children's Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1.Ages 1 to 17, any gender; 2.Diagnosed with acute lymphoblastic leukemia via bone marrow cytology, flow cytometry and/or cytogenetics; 3.Patients who achieve complete remission after induction chemotherapy and are scheduled to receive early intensive therapy (or delayed intensive therapy); 4.PLT > 100×10^9/L before initiation of the CAML regimen, and the patient is expected to tolerate and complete the CAML phase of treatment; 5.ECOG score = 2; 6.No obvious abnormalities in liver and kidney function (serum urea nitrogen, creatinine, transaminase and bilirubin are all = 1.5 times the upper limit of normal range); 7.No severe cardiac or pulmonary dysfunction, nor cerebrovascular diseases; 8.No history of mental illness; 9.Expected survival period greater than 3 months; 10.Voluntarily sign the written informed consent form to understand and comply with all research requirements;

Exclusion criteria

Exclusion criteria: 1.History of allergy to rhTPO; 2.History of thrombosis; 3.Thromboembolic or hemorrhagic diseases; 4.Congestive heart failure, arrhythmia, peripheral arteriovenous thrombosis requiring medical treatment at enrollment, or myocardial infarction or cerebral infarction occurring within 3 months prior to enrollment; 5.Failed to complete 80% of the scheduled administration of cytarabine and 6-mercaptopurine due to various reasons (for patients with confirmed homozygous NUDT15 or TPMT deficiency, the completion volume of 6-mercaptopurine shall be calculated after a 50% dosage reduction). 6.With a history of liver cirrhosis or portal hypertension; 7.Received platelet transfusion within 2 days prior to enrollment; 8.Currently suffering from severe or uncontrollable infections; 9.Myelofibrosis is present; 10.Other circumstances under which researchers believe patients are not suitable for participating in this study;

Design outcomes

Secondary

MeasureTime frame
Time required for platelet count to recover to =100×10^9/L;Incidence of Adverse Events;Median time to platelet count recovery =75×10^9/L;Length of hospital stay;PLT response rates on Day 7 and Day 14 after the initial administration of rhTPO;Minimum value of thrombocytopenia and its onset time;

Primary

MeasureTime frame
Frequency of platelet transfusions and total transfusion dose;PLT response rate on the 10th day after the initial administration of rhTPO;

Countries

China

Contacts

Public ContactLiu Yan

Baoding Hospital of Beijing Children's Hospital Capital Medical University

1516420424@qq.com+86 312 337 7852

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026