Post-chemotherapy neutropenia with high risk of developing infection in patients with acute leukemia undergoing induction, autologous or allogeneic hematopoietic stem cell transplantation. MedDRA version: 21.0 Level: LLT Classification code 10000835 Term: Acute leukemia System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10076734 Term: Chemotherapy induced neutropenia System Organ Class: 100000004851 MedDRA version: 22.0 Level: LLT Classification code 10067862
Conditions
Interventions
Trade Name: FOSFOMICINA CALCICA SOLUFOS
Pharmaceutical Form: Capsule
INN or Proposed INN: FOSFOMYCIN CALCIUM
CAS Number: 26016-98-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
FINBA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria: 1. Subjects must be able to understand the study procedures, comply with them, and give written informed consent prior to any specific study procedure. 2. 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. 3. 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: a. Performance status (Eastern Cooperative Oncology Group, ECOG) =2. b. Expected grade 3-4 mucositis. c. Age =65 years. d. Comorbidity index (HCTI) =3. e. Serum albumin 500 mg/m2. g. Total dose of cytarabine > 1 g/m2. h. Active or refractory neoplasia at the time of stem cell transplantation. 4. Performance status (Eastern Cooperative Oncology Group, ECOG) of 0 to 3. 5. Adequate organ function defined as: - Liver : bilirubin, alkaline phosphatase or SGOT =65 years) yes F.1.3.1 Number of subjects for this age range 78
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria cannot be included in this study: 1. Hypersensitivity to fluoroquinolones or fosfomycin. 2. Treatment with broad-spectrum antimicrobial therapy within 4 weeks of the first study treatment. 3. Prior intensive chemotherapy or stem cell transplantation. Treatment with hydroxyurea or corticosteroids used to control white blood cell count is allowed. 4. Fever of infectious origin or documented infection within 4 weeks of first study treatment. 5. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority in efficacy of oral fosfomycin versus oral ciprofloxacin in preventing febrile neutropenia in patients with acute leukemia treated with intensive chemotherapy and/or recipients of hematopoietic stem cell transplantation hematopoietic stem cell transplantation.;Secondary Objective: 1. To compare the rates and types of infections documented between the two treatment arms. 2. Compare overall survival from baseline to resolution of neutropenia in both treatment arms. 3. To evaluate the safety and tolerability of both prophylactic strategies. 4. Perform surveillance cultures to determine the rate of Gram-negative multiresistant colonization (GNMRB), analyze the time course of colonization, and identify clinical factors associated with the clearance or persistence of GNMRB bacteria in the gut of previously colonized patients. 5. To evaluate the utility of a metagenomic approach in the identification of underdetected colonization, as compared to traditional surveillance cultures. 6. To analyze changes in the fecal microbiome of patients from initiation of chemotherapy to resolution of neutropenia and compare these changes between both treatment arms.;Primary end point(s): Treatment will be discontinued upon the occurrence of any of the following events: 1) febrile neutropenia requiring antibacterial treatment (study endpoint). 2) Absolute Neutrophil Count (ANR) >0.5x109/L; 3) 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). 4) death.;Timepoint(s) of evaluation of this end point: On day 60 or the next chemotherapy cycle or after recovery of neutrophil count to 0.5X109/L. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To compare the rates and types of infections documented between the two treatment arms. 2. Compare overall survival from baseline to resolution of neutropenia in both treatment arms. 3. To evaluate the safety and tolerability of both prophylactic strategies. 4. Perform surveillance cultures to determine the rate of colonization of MRGN bacteria, analyze the time course of colonization, and identify clinical factors associated with clearance or persistence of MRGN bacteria in the gut of previously colonized patients. 5. To evaluate the utility of a metagenomic approach in the identification of underdetected colonization, as compared to traditional surveillance cultures. 6. To analyze changes in the fecal microbiome of patients from initiation of chemotherapy to resolution of neutropenia and compare these changes between both treatment arms.;Timepoint(s) of evaluation of this end point: On day 60 or the next chemotherapy cycle or after recovery of neutrophil count to 0.5X109/L. | — |
Countries
Spain
Contacts
Public ContactMar García
Agencia de ensayos clínicos-SCREN-IDIVAL
Outcome results
None listed