Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acut… (NCT05944211) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia
72 participantsStarted 2023-07
Plain-language summary
Randomized, controlled, open study to evaluate the efficacy and safety of Hetrombopag in the treatment of chemotherapy-induced thrombocytopenia(CIT) in patients with acute myeloid leukemia
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ages 18-70;
* Participant with a histologically or cytologically confirmed acute myeloid leukemia in complete remission (PLT≥100×109/L) (except acute promyelocytic leukemia);
* Participant who have completed induction therapy and achieved complete remission, have received ≤1 course of intensive consolidation chemotherapy, and will continue to receive intensive consolidation or maintenance chemotherapy;
* Intensive chemotherapy after complete remission including: high-dose or medium-dose cytarabine chemotherapy (1-1.5g/m2 q12h×3 days), standard-dose chemotherapy (cytarabine combined with anthracycline/anthraquinones, HHT, pohyllotoxin, etc.);
* Participant whose Expected survival time ≥3 months, and who can receive at least 2 cycles of intensive chemotherapy;
* ECOG performance status \<=2;
* Participants of childbearing age who agree to use reliable contraceptive methods;
* Patients signed the informed consent form and volunteered to participate in this study with good compliance;
Exclusion Criteria:
* Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
* Participant has a history of arterial or venous thrombosis within 6 months before screening (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism), or has clinical symptoms and medical history suggestive of thrombophilia;
* Participant has a history of severe cardiovascular disease within 6 months befor…
What they're measuring
1
Days that platelet count firstly rebound to 100×109/L