Chemotherapy-inducing Anemia
Conditions
Keywords
Acute myeloid leukemia, Chemotherapy, Anemia, Luspatercept
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Guangdong Second Provincial General Hospital
Nanfang Hospital, Southern Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First Affiliated Hospital of Guangxi Medical University
Guangzhou First People's Hospital
Affiliated Hospital of Guangdong Medical University
Guangzhou 8th People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. De novo AML patients; 2. Age ≥ 18 years and ≤ 60 years; 3. AML with ELN2022-low risk 4. Received 1-3 cycles of HDAC consolidation therapy 5. HGB 60-90 G/L 6. Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points; 7. Life expectancy ≥ 3 months; 8. Signed informed consent and able to understand and comply with the procedures required by this protocol.
Exclusion criteria
1. t-AML/sAML 2. Concurrent myelofibrosis 3. Patients unresponsive to red blood cell transfusions 4. Heart function \< grade 2 5. Renal function: creatinine clearance \< 30 ml/min 6. Liver function: ALTd \> 5 times normal, bilirubin \> 3 times normal 7. Uncontrolled hypertension, defined as recurrent elevations in diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment 8. History of stroke, deep vein thrombosis (DVT), pulmonary or arterial embolism within 6 months prior to randomization 9. Uncontrolled systemic fungal, bacterial, or viral infection (defined as persistent infection-related signs/symptoms that do not improve despite appropriate antibiotic, antiviral, and/or other treatments), known human immunodeficiency virus (HIV), active hepatitis B virus (HBV) infection, and/or hepatitis C. (HCV) infection 10. History of severe allergy or allergic reaction to recombinant proteins, or allergy to rotezip or excipients 11. Pregnant or breastfeeding women 12. Patients deemed unsuitable for enrollment by the investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of 50% increase in hemoglobin levels from baseline | Days 1-28 post chemotherapy | The time of hemoglobin levels increasing 50% from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of HGB < 60 G/L during the treatment course (1-28 days) | Days 1-28 after AML chemistry treatment | The duration of HGB \< 60 G/L during this consolidation treatment course (days 1-28); |
| Incidence of HGB < 60 G/L during the treatment course (days 1-28) | Days 1-28 after chemotherapy | The incidence of HGB \< 60 G/L during this consolidation treatment course (days 1-28); |
| Red blood cell transfusion volume | Days 1-28 after AML chemistry treamtment | Red blood cell transfusion volume during this consolidation treatment course (days 1-28); |
| MRD negative rate | 6 months after AML chemistry treamtment | MRD negative rate within 6 months; |
| Anemia recurrence rate | 12 months after AML chemistry treamtment | Relapse rate 12 months after chemotherapy; |
Countries
China
Contacts
CONTACTGuopan Yu, PhD
CONTACTTianmiao Yu, Master
Outcome results
None listed