FOSFOMYCIN CALCIUM for Acute leukemia | Post-chemotherapy neutropenia | Febrile neutropenia

Inclusion criteria

• {"criterion_text":"- Subjects must be able to understand the study procedures, comply with them, and give written informed consent prior to any specific study procedure.\n- Adult subjects ≥ 18 years of age with a diagnosis of acute leukemia who are to receive their first course of chemotherapy or adult subjects ≥ 18 years of age who are candidates for a first stem cell transplant.\n- Expected neutropenia of 100x109/L lasting at least seven days. In the case of an expected range of 100-500x109/L neutropenia lasting seven days or longer, at least one of the following risk factors for infection must be present:\n- b. Expected grade 3-4 mucositis. c. Age ≥65 years. d. Comorbidity index (HCTI) ≥3. e. Serum albumin< 35 g/L. f. Total dose of etoposide > 500 mg/m2. g. Total dose of cytarabine > 1 g/m2. h. Active or refractory neoplasia at the time of stem cell transplantation.\n- Performance status (Eastern Cooperative Oncology Group, ECOG) of 0 to 3.\n- Adequate organ function defined as: Adequate organ function defined as: - Liver : bilirubin, alkaline phosphatase or SGOT < 3 times the upper limit of normal (unless attributable to tumor activity). - Renal : creatinine ≤ 250 μmol/l (2.5 mg/dL) (unless attributable to AML activity).\n- Life expectancy greater than 3 months\n- Women of childbearing age should not be pregnant or breastfeeding and should have a negative pregnancy test at the time of screening. Women of childbearing age and men with female partners of childbearing age must agree to practice 2 highly effective contraceptive measures and must agree not to become pregnant or father a child while receiving any study therapy and for at least 3 months after completion of treatment."}

Exclusion criteria

• {"criterion_text":"- Hypersensitivity to fluoroquinolones or fosfomycin.\n- Treatment with broad-spectrum antimicrobial therapy within 4 weeks of the first study treatment.\n- Prior intensive chemotherapy or stem cell transplantation. Treatment with hydroxyurea or corticosteroids used to control white blood cell count is allowed\n- Fever of infectious origin or documented infection within 4 weeks of first study treatment\n- Presence of any serious psychiatric illness or physical condition that, in the judgment of the physicians, contraindicates the patient's inclusion in the clinical trial."}

Primary endpoints

• {"endpoint_text":"- febrile neutropenia requiring antibacterial treatment","definition_or_measurement_approach":"Incidence of febrile neutropenia events that require antibacterial treatment (as stated: 'febrile neutropenia requiring antibacterial treatment')."}
• {"endpoint_text":"- Absolute Neutrophil Count (ANR) >0.5x109/L","definition_or_measurement_approach":"Measurement of Absolute Neutrophil Count (ANR) with threshold >0.5 x 10^9/L."}
• {"endpoint_text":"- If the subject fails to achieve more than 0.5x109/L neutrophils the study will end when more than 60 days have elapsed since the onset of neutropenia, or on the first day of the next chemotherapy cycle (whichever is earlier)","definition_or_measurement_approach":"Time-to-event rule: if ANC remains ≤0.5x10^9/L, follow-up ends at >60 days from neutropenia onset or at start of next chemotherapy cycle, whichever occurs first."}
• {"endpoint_text":"- death","definition_or_measurement_approach":"All-cause mortality (death) as an endpoint."}

Spain

Earliest CTIS Part Ii Submission Date

18-12-2024

Latest Decision Or Authorization Date

21-01-2025

Processing Time Days

34

Number Of Sites

11

Number Of Participants

156

Primary sponsor

Full Name

Fundacion Para La Investigacion Y La Innovacion Biosanitaria Del Principado De Asturias

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain