Diseases of blood system
Conditions
Interventions
I:Fosapitam 150mg (Day1)
II:Fosapitam 150mg (Day1-3-5-7)
III:Fosapitam 150mg (Day1-5-9)
Sponsors
Department of Hematology, Xiangya Third Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily join the group, sign informed consent, good compliance, can cooperate with experimental observation; 2. Patients who are going to receive hematopoietic stem cell transplantation, and the pretreatment chemotherapy regimen is high risk of emesis; 3. Aged 18-65 years old; 4. Good physical condition ECoG score 0-2; 5. The expected survival time is more than 3 months.
Exclusion criteria
Exclusion criteria: 1. patients who participated in other clinical trials within 4 weeks before entering the group or at the same time; 2. patients with gastrointestinal obstruction, central nervous system leukemia, or other potential diseases (such as metabolic disorder, severe liver and kidney dysfunction) that may cause and / or aggravate nausea and vomiting; 3. patients with vomiting or II - III degree nausea before pretreatment; 4. those with severe cardiac and pulmonary dysfunction; 5. there are important organ dysfunction, and laboratory examination meets the basic requirements of chemotherapy, namely: AST and Al in serum 3 ULN (AST and ALT >=5.0 ULN); The total bilirubin >=3 ULN; Serum creatinine >=3 ULN; The interval of Q-T in ECG >=450ms; The serum electrolytes (sodium, potassium, chlorine and total calcium) are abnormal; 6. poor compliance or inability to cooperate with treatment and narrative of treatment response; 7. the study drug (fosapitam, aripiptam and 5-HT3 receptor antagonists) were allergic; 8. pregnant or lactation patients; 9. patients who had been used chemotherapy drugs with high risk of vomiting within 2 weeks; 10. other situations in which the researchers believe that they cannot be included in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate (CRR) of vomiting in 12 days (0-288h, acute + delayed) after pretreatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate of vomiting in acute phase (CRR): the proportion of patients with complete response to vomiting within 7 days of pretreatment chemotherapy (0-168h);CRR of delayed vomiting (168-288h);Complete vomiting control rate (CCR): acute phase, delayed phase and total observation period;The time from the beginning of pretreatment to the first vomiting attack (H) and the degree of vomiting (times / day);The time from the beginning of pretreatment to the first rescue treatment (H) and the proportion of patients rescued;Proportion of patients without obvious nausea (VAS <25mm) and patients without nausea (VAS <5mm);The degree of decrease of food intake in the total observation period after pretreatment;Trough concentration of CYP3A4 drugs; | — |
Countries
China
Contacts
Public ContactLi Xin
Department of Hematology, Xiangya Third Hospital, Central South University
Outcome results
None listed