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

Phase 1

• Conditions: Aplastic Anaemia, Myelodysplastic syndromes, Acute Myeloid Leukaemia undergoing immunosuppression therapy, high dose chemotherapy or reduced intensity stem cell transplantation; MedDRA version: 19.0Level: LLTClassification code 10038271Term: Refractory anaemia with excess blasts in transformationSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: LLTClassification code 10059041Term: Allogeneic peripheral haematopoietic stem cell transplantSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 19.0Level: LLTClassification code 10067862Term: Allogeneic stem cell transplantationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 19.0Level: PTClassification code 10038270Term: Refractory anaemia with an excess of blastsSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: LLTClassification code 10010776Term: Constitutional aplastic anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 19.0Level: LLTClassification code 10068063Term: Aplastic anaemia relapseSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 19.0Level: LLTClassification code 10036699Term: Primary idiopathic aplastic anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 19.0Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: PTClassification code 10001756Term: Allogenic bone marrow transplantation therapySystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2016-001223-31-GB
• Lead Sponsor: King's College Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-07
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified