Thrombocytopenia
Conditions
Interventions
Cohort 1(Treatment Group):During the prophylactic phase (X+1 cycle), 24-48 hours after the end of chemotherapy, roproxitim N01 prophylaxis was received, with an initial dose of 3 µg/kg, once a week, s
Cohort 2 (matched enrollment based on cohort 1 patient characteristics (number of chemotherapy drugs, number of previous lines of therapy, previous platelet-raising drug use)):Conventional treatment o
Sponsors
Fuling Hospital Chongqing University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age>=18 years old at enrollment, both males and females; (2) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; (3) Life expectancy > 12 weeks; (4) Malignant tumors confirmed by histology or cytology, excluding myeloid malignancies; (5) No chemotherapy dose reduction of>=15% occurred during this chemotherapy period; (6) Planned to perform>=2 chemotherapy sessions and the chemotherapy regimen has not been changed; (7) The previous PLT during this chemotherapy meets the following requirements: The lowest platelet count (PLT) after chemotherapy during the screening period (X cycle) is =50×10^9/L but =1.5×10^9/L;Hemoglobin>=90g/L; Platelet count>=100×10^9/L; Liver function:Alanine aminotransferase (ALT) and aspartateaminotransferase (AST) and alkaline phosphatase (ALP)=30g/L; Renal function: Calculated creatinine clearance (CrCl)>= 60 mL/min (CrCl calculated according to the Cockcroft-Gault formula) or serum creatinine<=1.5×ULN; (9)Female subjects of childbearing potential (theoretically female aged 15 to 49, including unmarried, married or widowed) must have a negative serum pregnancy test within 30 days before the first use of the drug;Female subjects of childbearing age must use acceptable contraceptive methods from the screening onwards, and must agree to continue using contraceptive methods for at least 6 months after the last dose of the study drug; male subjects who have not been sterilized must use acceptable contraceptive methods from the screening onwards to at least 6 months after the last dose; the specific time to stop using contraception should be determined by the researcher; (10)The subjects voluntarily participate in this study and are able to cooperate with treatment, regular evaluation, follow-up and other requirements related to this study, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Subject has a history of thrombosis <=3 months before enrollment. (2) Received radiation therapy <=1 month prior to enrollment, or had a radiation plan for the next two chemotherapy cycles. (3)Use of Chinese herbal medicines or proprietary Chinese medicines that regulate hematopoietic functions within 1 week before enrollment. (4)Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. (5)Subjects who had undergone major surgical procedures or experienced severe trauma within 30 days before the first dose, or had surgery planned after the first dose. (6)History of drug abuse, alcoholism or drug abuse. (7)Pregnant or lactating female. (8)The subjects have other underlying diseases, infections, treatments, and laboratory test abnormalities that are not well controlled, which may confuse the study results and affect the subject's entire participation in the study, or participation in the study may not be in the subject's best interests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with PLT >100×10^9/L on D20 during the prevention period (X+1 cycle); | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with PLT >75×10^9/L on D20 during the prevention period (X+1 cycle);The proportion of patients requiring blood transfusion during the prevention period (X+1 cycle);The proportion of patients with chemotherapy dose reduction>=15% during the observation period (X+2 cycle);The proportion of patients with chemotherapy delay >= days during the observation period (X+2 cycle);Safety evaluation: including the incidence and severity of adverse events (AEs), and clinically significant abnormal laboratory test results; | — |
Countries
China
Contacts
Public ContactGuofa Xu
Chongqing University FuLing Hospital
Outcome results
None listed