Health Condition 1: C919- Lymphoid leukemia, unspecified
Conditions
Interventions
Intervention1: Voriconazole: Voriconazole is used to treat serious fungal or yeast infections, such as aspergillosis (fungal infection in the lungs), candidemia (fungal infection in the blood), esopha
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: High risk B-acute lymphoblastic leukemia Intermediate risk B Cell Acute Lymphoblastic Leukemia. B Cell lymphoblastic lymphoma. T Cell Acute Lymphoblastic Leukemia T Cell Lymphoblastic Lymphoma. During induction phase of therapy. Total bilirubin should be less than 1.5 x upper limit of normal for age. SGOT or SGPT less than 5 x ULN for age
Exclusion criteria
Exclusion criteria: Standard risk Acute Lymphoblastic Leukemia Patients with ALL for whom risk-group is unavailable. Patients with a history of allergy to any of the study drugs. A documented history of Invasive Fungal Infection within 30 days prior to randomization. Patients on treatment for Invasive Fungal Infection. Patients not consenting for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the efficacy of various antifungal prophylaxis in preventing IFI in children with acute lymphoblastic leukemia during the induction and consolidation phases of therapy.Timepoint: Assessments will be done on at the start and end of the induction and consolidation phases of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| To asses mortality due to any cause.Timepoint: During the course of antifungal treatment.;To assess proven or probable IFI related invasive fungal infection related mortality.Timepoint: During the course of antifungal treatment.;To assess the incidence of IFI, including invasive aspergillosis, candidiasis, mucor and any other IFI.Timepoint: During the course of antifungal treatment.;To assess prophylaxis failure. This would be defined as a development of proven or probable IFI as defined above or the occurrence of an adverse event possibly or probably related to the study treatment, resulting in discontinuation of treatment, inability to deliver drug due to any reason for greater than 25% of the stipulated study duration or receipt of any other systemic antifungal agent for 5 days or more for persistent fever or suspected IFITimepoint: During the course of antifungal treatment or post discontinuation.;Corelate voriconazole and posaconazole serum levels whenever available with drug doses and breakthrough IFI.Timepoint: During the course of antifungal treatment. | — |
Countries
India
Contacts
Public ContactDr Shyam Srinivasan
Tata Memorial Hospital
Outcome results
None listed