Schedule of activities | ||||
---|---|---|---|---|
Acute leukemias | ||||
Enrollment | Initial Visit and chemotherapy cycle 1 | Cycle 2 | Close-outa | |
Time point | Week 1 | Week 2 | Week 6 | Week 10 |
Enrolment | ||||
Screening and Informed Consent | X | |||
Physical Examen | X | X | X | |
Clinical Record | X | X | X | |
HIV Test and Pregnancy test | X | |||
Interventions | ||||
Medication dispensing | X | X | X | |
Follow-up visit | X | X | X | |
Safety Assessment | ||||
Hemogram | X | X | ||
Transaminase AST | X | X | ||
Transaminase ALT | X | X | ||
Alkaline Phosphatase | X | X | ||
Total Bilirubin | X | X | ||
Triglycerides | X | X | ||
Total Cholesterol | X | X | ||
Blood Urea Nitrogen (BUN) | X | X | ||
Creatinine | X | X | ||
Urinalysis | X | X | ||
Uric Acid | X | X | ||
LDH (Lactate Dehydrogenase) | X | X | ||
Lactic Acid | X | X | ||
Ferritin | X | X | ||
Albumin | X | X | ||
Iron | X | X | ||
Electrocardiogram | X | X | ||
Echocardiogram | X | X | ||
Efficacy Assessment | ||||
Myelogram and flow cytometry | X | X | ||
Tumor Antigens | X | X | ||
Metabolome | X | X | ||
Microbiome Analysis | X | X | ||
Proinflammatory Cytokines | X | X | ||
Circulating DNA | X | X | ||
Ketone Bodies | X | X | ||
Tumor Infiltration | X | X | ||
QLQ C-30 Quality of Life Surveys | X | X | X | |
Progression-Free Survival | X | X |