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A clinical study of the efficacy and safety of recombinant human thrombopoietin (rhTPO) for secondary prevention of thrombocytopenia after chemotherapy for lymphoma

Clinical study on the efficacy and safety of recombinant human thrombopoietin in the prevention and treatment of thrombocytopenia after chemotherapy for lymphoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081344
Enrollment
Unknown
Registered
2024-02-28
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

lymphoma

Interventions

test group A:The previous chemotherapy cycle (control cycle) showed chemotherapy-induced thrombocytopenia with a minimum platelet value 100×10^9/L was seen for 3 consecutive days on days 5-10 of rhTPO
test group B:The previous chemotherapy cycle (control cycle) showed chemotherapy-induced thrombocytopenia with a minimum platelet value 100×10^9/L was seen for 3 consecutive days on days 5-10 of rhTPO

Sponsors

Shanxi Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age 18~75 years old, male and female. 2.Meet the diagnostic criteria of diffuse large B-cell lymphoma and peripheral T-cell lymphoma. 3.Patients who clinically need to receive at least three or more consecutive cycles of CHOP chemotherapy regimen, R-CHOP-like chemotherapy regimen. 4.Platelet count minimum <50×109/L or 50×109/L <minimum <75×109/L in the previous chemotherapy cycle. 5.Dose adjustment of the chemotherapy regimen between the control cycle and the control cycle does not exceed ±10%. 6.No obvious abnormality in liver and kidney function (serum urea nitrogen, creatinine, transaminase, bilirubin are =2.5 times of the upper limit of normal). 7.No abnormality in coagulation function (APTT, PT, Fg, TT and D-dimer = 2 times of the upper limit of normal) 8.No grade 3 to 4 cardiac or pulmonary dysfunction according to NCI CTC AE v4.03. 9.Life expectancy is greater than 12 weeks. 10.Patients voluntarily participated in this study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of severe allergy to biological agents. 2. Thromboembolic or hemorrhagic disease, or a history of recent thrombosis. 3. History of psychiatric disorders. 4. Pregnancy or lactation, or inability to use contraception during the study. 5. Comorbid acute severe infections. 6. Previous cycle of treatment with TPORA, IL-11 drugs. 7. Other conditions that the investigator believes the patient should not participate in this study.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with grade III and IV thrombocytopenia, per chemotherapy cycle;

Secondary

MeasureTime frame
Change in platelet count, per chemotherapy cycle;Number and dose of platelet transfusions, per chemotherapy cycle;For each cycle of chemotherapy, the lowest value of platelet reduction and the time of occurrence;;Duration of days with platelet counts less than 25 x 10^9/L, 50 x 10^9/L, and 75 x 10^9/L per chemotherapy cycle;;Patient bleeding status per chemotherapy cycle;;Number of days of rhTPO salvage therapy performed, per chemotherapy cycle;;For each cycle of chemotherapy, the total number of days patients were hospitalized;Per chemotherapy cycle, incidence of cardiotoxic adverse events;

Countries

China

Contacts

Public ContactLi Ma

Shanxi Cancer hospital

shanximali123@outlook.com+86 138 3457 8927

Outcome results

None listed

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