Incidence of Invasive Fungal Disease in Patients receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole tablet Prophylaxis

Incidence of Invasive Fungal Disease in Patients receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole Prophylaxis - King's Invasive Aspergillosis Study II (KIASII)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001223-31-GB

Enrollment

150

Registered

2016-09-07

Start date

2016-10-11

Completion date

Unknown

Last updated

2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aplastic Anaemia, Myelodysplastic syndromes, Acute Myeloid Leukaemia undergoing immunosuppression therapy, high dose chemotherapy or reduced intensity stem cell transplantation MedDRA version: 19.0 Level: LLT Classification code 10038271 Term: Refractory anaemia with excess blasts in transformation System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: LLT Classification code 10059041 Term: Allogeneic peripheral haematopoi

Interventions

Trade Name: Noxafil® Product Name: Noxafil Gastro resistant tablets Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult > or = to 18 years 2. Patients with aplastic anaemia, MDS or AML undergoing: IST; or Intensive chemotherapy such as induction chemotherapy; or RIC allogeneic HSCT 3. Able to swallow and retain orally administered medication 4.Patients must agree to use and apply with effective contraception without interruption throughout the duration of study drug therapy Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150

Exclusion criteria

Exclusion criteria: 1. Refusal or inability to consent 2. Autologous HSCT 3. Contraindicated medications 4. Current evidence of IFD diagnosis or treatment 5.Women who are pregnant or lactating

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the cumulative incidence of invasive fungal disease (IFD) in patients given posaconazole tablet as primary prophylaxis at the start of admission for immunosuppressive therapy, chemotherapy or allogeneic RIC HSCT.;Secondary Objective: SECONDARY 1. To determine the cumulative incidence of IFD within treatment groups. 2. To measure trough plasma levels of posaconazole and correlate with the incidence of IFD 3. To determine the number of patients who received antifungal treatment 4. To determine if calcineurin inhibitors such as cyclosporine A or tacrolimus adversely affect the plasma posaconazole levels 5. To determine the clinical response to antifungal therapy 6. To determine the clinical performance of ß-D-glucan, galactomannan, bi (methylthio)gliotoxin and PCR diagnostic tests 7. To assess the risk factors (e.g. baseline CT abnormalities, baseline ILR2 and MCP1 levels, GVHD, prolonged monocytopenia, poor performance status) for IFD EXPLORATORY 1. To determine IFD incidence, number of patients on antifungal prophylaxis and treatment beyond week 24 of the study 2. To determine overall survival 3.To determine the pharmaco-economics of IFD diagnosis and treatment;Primary end point(s): Cumulative incidence of IFD in all treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft) assessed over 24 weeks from Day 1 of study entry;Timepoint(s) of evaluation of this end point: Between day 1 and week 24	—

Measure

Time frame

Main Objective: To determine the cumulative incidence of invasive fungal disease (IFD) in patients given posaconazole tablet as primary prophylaxis at the start of admission for immunosuppressive therapy, chemotherapy or allogeneic RIC HSCT.;Secondary Objective: SECONDARY 1. To determine the cumulative incidence of IFD within treatment groups. 2. To measure trough plasma levels of posaconazole and correlate with the incidence of IFD 3. To determine the number of patients who received antifungal treatment 4. To determine if calcineurin inhibitors such as cyclosporine A or tacrolimus adversely affect the plasma posaconazole levels 5. To determine the clinical response to antifungal therapy 6. To determine the clinical performance of ß-D-glucan, galactomannan, bi (methylthio)gliotoxin and PCR diagnostic tests 7. To assess the risk factors (e.g. baseline CT abnormalities, baseline ILR2 and MCP1 levels, GVHD, prolonged monocytopenia, poor performance status) for IFD EXPLORATORY 1. To determine IFD incidence, number of patients on antifungal prophylaxis and treatment beyond week 24 of the study 2. To determine overall survival 3.To determine the pharmaco-economics of IFD diagnosis and treatment;Primary end point(s): Cumulative incidence of IFD in all treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft) assessed over 24 weeks from Day 1 of study entry;Timepoint(s) of evaluation of this end point: Between day 1 and week 24

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Secondary

Measure	Time frame
Secondary end point(s): 1.Cumulative incidence of IFD within treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft) assessed over 24 weeks from Day 1 of study entry 2.Trough plasma levels of posaconazole correlated with the incidence of IFD assessed over 24 weeks from Day 1 of study entry 3.The number of patients who received antifungal treatment assessed over 24 weeks from Day 1 of study entry 4.Whether calcineurin inhibitors such as cyclosporine A or tacrolimus adversely affect plasma posaconazole levels assessed over 24 weeks from Day 1 of study entry 5.Clinical response to antifungal therapy assessed over 24 weeks from Day 1 of study entry 6.Clinical performance of GM, BDG, bmGT and PCR assessed over 24 weeks from Day 1 of study entry 7.The risk factors (baseline CT abnormalities, baseline IL2R and MCP1 levels, GVHD, prolonged monocytopenia, poor performance status) for IFD assessed over 24 weeks from Day 1 of study entry Exploratory Endpoints 1.IFD incidence, number of patients on antifungal prophylaxis and treatment from 24 weeks until 12 months 2.Overall survival at 6, 9 and 12 months 3.Pharmaco-economics of IFD diagnosis and treatment assessed over 12 months ;Timepoint(s) of evaluation of this end point: Secondary endpoints assessed between day 1 and week 24 Exploratory endpoints assessed at 12 months	—

Measure

Time frame

Secondary end point(s): 1.Cumulative incidence of IFD within treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft) assessed over 24 weeks from Day 1 of study entry 2.Trough plasma levels of posaconazole correlated with the incidence of IFD assessed over 24 weeks from Day 1 of study entry 3.The number of patients who received antifungal treatment assessed over 24 weeks from Day 1 of study entry 4.Whether calcineurin inhibitors such as cyclosporine A or tacrolimus adversely affect plasma posaconazole levels assessed over 24 weeks from Day 1 of study entry 5.Clinical response to antifungal therapy assessed over 24 weeks from Day 1 of study entry 6.Clinical performance of GM, BDG, bmGT and PCR assessed over 24 weeks from Day 1 of study entry 7.The risk factors (baseline CT abnormalities, baseline IL2R and MCP1 levels, GVHD, prolonged monocytopenia, poor performance status) for IFD assessed over 24 weeks from Day 1 of study entry Exploratory Endpoints 1.IFD incidence, number of patients on antifungal prophylaxis and treatment from 24 weeks until 12 months 2.Overall survival at 6, 9 and 12 months 3.Pharmaco-economics of IFD diagnosis and treatment assessed over 12 months ;Timepoint(s) of evaluation of this end point: Secondary endpoints assessed between day 1 and week 24 Exploratory endpoints assessed at 12 months

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Countries

United Kingdom

Contacts

Public ContactProfessor Antonio Pagliuca

King's College Hospital NHS Foundation Trust

antonio.pagliuca@kcl.ac.uk44203299 5765

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026