This study aims to explore the feasibility, safety, and preliminary efficacy of rotegcipipone in the treatment of chemotherapy-inducing anemia in AML with a multicenter, prospective, single-arm trial, providing clinical evidence for subsequent clinical development.
The application of rotegcipipone in the treatment of chemotherapy-inducing anemia in AML has not yet been systematically studied. Animal studies have shown that rotegcipipone can improve the recovery of anemia after chemotherapy. The bone marrow microenvironment after chemotherapy is often deteriorated due to cytokine storms and hematopoietic stem cell damage, which may further exacerbate erythroid regeneration disorders. Based on rotegcipipone's dual mechanism of improving the hematopoietic microenvironment and promoting erythrocyte maturation, it may overcome the limitations of existing therapies after chemotherapy. Furthermore, its safety profile (primarily grade 1-2 adverse reactions in MDS and β-thalassemia) provides a potential advantage for its application in vulnerable patients after chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
First, enrolled patients were randomized to received rotezipeptide with a dosage of 1mg/kg at the day 1 versus day 10 post chemotherapy. Each groups were analyzed to enroll et least 10 patients. Second, after working out which day should be the better one for the treatment of rotezipeptide in phase 1 study, at least 20 patients were enrolled to received rotezipeptide with the same dose at the above day to further work out the efficacy and safety of rotezipeptide in the treatment of CIA in AML.
Department of Hematology, Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China
RECRUITINGTime of 50% increase in hemoglobin levels from baseline
The time of hemoglobin levels increasing 50% from baseline
Time frame: Days 1-28 post chemotherapy
Duration of HGB < 60 G/L during the treatment course (1-28 days)
The duration of HGB \< 60 G/L during this consolidation treatment course (days 1-28);
Time frame: Days 1-28 after AML chemistry treatment
Incidence of HGB < 60 G/L during the treatment course (days 1-28)
The incidence of HGB \< 60 G/L during this consolidation treatment course (days 1-28);
Time frame: Days 1-28 after chemotherapy
Red blood cell transfusion volume
Red blood cell transfusion volume during this consolidation treatment course (days 1-28);
Time frame: Days 1-28 after AML chemistry treamtment
MRD negative rate
MRD negative rate within 6 months;
Time frame: 6 months after AML chemistry treamtment
Anemia recurrence rate
Relapse rate 12 months after chemotherapy;
Time frame: 12 months after AML chemistry treamtment
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