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| Name | Class |
|---|---|
| Nanfang Hospital, Southern Medical University | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotesip treatment group | Experimental | Patients were screened and enrolled in the treatment group to evaluate the efficacy and safety of rotezipeptide in the treatment of chemotherapy-inducing anemia in AML. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luspatercept Injectable Product | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time of 50% increase in hemoglobin levels from baseline | The time of hemoglobin levels increasing 50% from baseline | Days 1-28 post chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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); | Days 1-28 after AML chemistry treatment |
| Incidence of HGB < 60 G/L during the treatment course (days 1-28) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of people experiencing treatment-related adverse events | According to the CTCAE v5.0 assessment, the number of people who experienced treatment-related adverse events included both hematological and non-hematological toxicities. | Days 1-28 after Luspatercept treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guopan Yu, PhD | Contact | +8615876559968 | yugpp@163.com | |
| Tianmiao Yu, Master | Contact | yutm96@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology, Guangdong Second Provincial General Hospital | Recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Guangzhou First People's Hospital | OTHER |
| Affiliated Hospital of Guangdong Medical University | OTHER |
| Guangzhou 8th People's Hospital | OTHER |
Patients were screened and enrolled in the treatment group to evaluate the efficacy of rotezipeptide in the treatment of chemotherapy-inducing anemia (CIA) in AML. 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.
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The incidence of HGB < 60 G/L during this consolidation treatment course (days 1-28); |
| Days 1-28 after chemotherapy |
| Red blood cell transfusion volume | Red blood cell transfusion volume during this consolidation treatment course (days 1-28); | Days 1-28 after AML chemistry treamtment |
| MRD negative rate | MRD negative rate within 6 months; | 6 months after AML chemistry treamtment |
| Anemia recurrence rate | Relapse rate 12 months after chemotherapy; | 12 months after AML chemistry treamtment |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |