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Single site, randomized controlled clinical study of the efficacy and safety of rh TPO in treatment of thrombocytopenia after chemotherapy for children acute lymphoblastic leukemia

Single site, randomized controlled clinical study of the efficacy and safety of rh TPO in treatment of thrombocytopenia after chemotherapy for children acute lymphoblastic leukemia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006071
Enrollment
Unknown
Registered
2015-03-13
Start date
2015-11-01
Completion date
Unknown
Last updated
2017-04-18

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:TPO 300 U/kg ,subcutaneous injection once daily, period of treatment is equal to or less than 14 days. If the platelet count >50*10^9 / L, test two times continuously(not the same day),less

Sponsors

The Children's Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 17 Years

Inclusion criteria

Inclusion criteria: (1)Age: <18 years old, male or female; (2)Meet the diagnostic criteria of ALL, middle and high risk, after complete remission after induction chemotherapy, is under going consolidation therapy; (3)ECOG score <=2 points; (4)Life expectancy more than 12 weeks; (5)In the consolidation stage of treatment, bone marrow suppression is strong, leading to platelet count <80*10^9/L (test two times continuously), without intervention, platelet count is expected to be less than 20*10^9/L; (6)The serum creatinine level is less than or equal to 97 mol/l (1.5mg/dl), serum transaminase, bilirubin level lower than 2.5 times the upper limit of normal value; (7)No history of mental illness; (8)Children legal guardians' approval and signed informed consent form must be obtained.If the child could make decision to participate in the study, the child's approval and signed informed consent form also must be obtained.

Exclusion criteria

Exclusion criteria: (1)Using other drugs that could promote platelet production during the study, for example: Interleukin 11, TPO receptor agonist, Chinese medicine that could promote platelet production; (2)History of embolism; (3)Abnormal liver and kidney function, the serum transaminase and bilirubin equal to and more that 2.5 times of the upper limit of normal, Cr >97 mol/l (1.5mg/dl); (4)Severe organ dysfunction or disease, such as heart, liver, kidney, pancreas and serious diseases of nervous system and dysfunction; (5)At the same time with other tumor; (6)The child who could not adhere to medication in according to the study protocol; (7)The emergence of antiplatelet antibody in children (Platelet transfusion refractoriness, other manifestations of immune thrombocytopenic appears); (8)The investigator think that the child should not participate in the study.

Design outcomes

Primary

MeasureTime frame
platelet count;

Countries

China

Contacts

Public ContactWeiqun Xu
vicky__xu@sina.com+86 13958096033

Outcome results

None listed

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