Evaluating the Efficacy and Safety of QL0911 in the Prevention of Chemotherapy- Induced Thrombocy… (NCT05554913) | Clinical Trial Compass
CompletedPhase 2/3
Evaluating the Efficacy and Safety of QL0911 in the Prevention of Chemotherapy- Induced Thrombocytopenia
China63 participantsStarted 2022-11-08
Plain-language summary
To evaluate the efficacy and safety of QL0911 to prevention chemotherapy-induced thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia occurs as a side effect of chemotherapy treatments.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Aged ≥18 years old;
* Histopathological or cytological examination confirmed solid tumor or lymphoma (including NSCLC, breast cancer, bladder cancer, pancreatic cancer, etc.), chemotherapy cycle of 21 days, and using of one or more of the following chemotherapy drugs: gemcitabine; Platinum, including carboplatin, nedaplatin, cisplatin, lobaplatin, etc.; Anthracyclines, including doxorubicin, daunorubicin, epirubicin, etc.; Taxa, including paclitaxel, docetaxel, etc.
* The current chemotherapy regimen should be consistent with that of the previous chemotherapy cycle, including the chemotherapy drugs and the dosages, without adding or subtracting drugs or dosages;
* At least two platelet counts with an interval of more than 24 hours in the chemotherapy cycle before enrollment was grade 2 or higher thrombocytopenia;
* The platelet count was between 75×10\^9/L-150×10\^9/L (including both ends) 1 day before chemotherapy or the day of Randomization;
* At the time of screening, the expected survival time is ≥12 weeks, and the current chemotherapy regimen can be accepted for at least 2 cycles;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;
* Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent form.
Exclusion Criteria:
* Suffering from other hematopoietic system diseases besides lymphoma, including leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multip…
What they're measuring
1
Proportion of patients who had an efficacy response during the double-blind period