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Tannic Acid

Conditioning treatment "Thiotepa-Treosulfan-Fludarabine"; PBSC graft; GvHD prophylaxis; Primary antifungal prophylaxis.

Thiotepa iv 5 mg/kg/bid (total dose TD 10 mg/kg) day -3,-2; Treosulfan iv 14g/mq/day (TD 42 g/mq) as a single daily dose day -6, -5, -4; Fludarabine iv 30 mg/m2 (TD 150 mg/m2) day -6, -5, -4, -3, -2. Thiotepa TD 5 mg/kg and treosulfan TD 36 g/mq dose reduction according to age \> 65 years.

Conditioning treatment "Thiotepa-Treosulfan-Fludarabine"

(target 4-8 × 106 CD34+ cells/kg patient body weight)

PBSC graft

Sirolimus orally, monitored two times a week to maintain a target therapeutic plasma level of 8-15 ng/ml from day +5.

Mycophenolate 15 mg/kg bid i.v. or per os day +5 through +28. Cyclophosphamide 50 mg/kg i.v. day +3+4. Mesna: \>80% of the cyclophosphamide dose in 3 divided doses from day +3 daily through day +5.

GvHD prophylaxis

Posaconazole delayed-release tablet \[available in 100 mg tablets\]: 300 mg twice daily on the first day followed by a maintenance dose of 300 mg once a day, starting on the day 0 to day 85.

Primary antifungal prophylaxis

SIR-POSA is a phase II trial of peripheral blood stem cell (PBSC) transplantation from a partially compatible family (Haplo) donor in patients with a blood tumor (myelodysplastic syndrome (MDS) and acute leukemia) treated for the prevention of primary fungal infections with posaconazole.

The aim is evaluate the composite end-point graft-versus-host disease-free, relapse-free survival (GRFS) in these patients and evaluate the feasibility and efficacy of posaconazole oral tablets as primary antifungal prophylaxis.

Peripheral Blood Stem Cell Transplantation From Family Haploidentical Donors in Patients With Myelodysplastic Syndrome and Acute Leukemia Under Primary Prophylaxis With Posaconazole

A Phase II Trial of Allogeneic Peripheral Blood Stem Cell Transplantation From Family Haploidentical Donors in Patients With Myelodysplastic Syndrome and Acute Leukemia Under Primary Antifungal Prophylaxis With Posaconazole.

GRFS events is defined as the first event among grade III-IV acute Graft vs. Host Disease (GVHD), severe chronic GVHD, relapse and death from any cause

The rate of proven, probable and possible invasive fungal diseases documented within the first 85 days after transplantation

Ciceri Fabio

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Peripheral Blood Stem Cell Transplantation From Family Haploidentical Donors in Patients With Myelodysplastic Syndrome and Acute Leukemia Under Primary Prophylaxis With Posaconazole	NCT03434704	Transplant-Rela... Leukemia, Acute Myelodysplastic... Graft Vs Host D... Fungal Infectio...	Conditioning tr... PBSC graft GvHD prophylaxi... Primary antifun...	18 Years -	IRCCS San Raffaele
Peripheral Blood Stem Cell Transplantation From Family Haploidentical Donors in Patients With Myelodysplastic Syndrome and Acute Leukemia Under Primary Prophylaxis With Posaconazole	NCT03434704	Transplant-Rela... Leukemia, Acute Myelodysplastic... Graft Vs Host D... Fungal Infectio...	Conditioning tr... PBSC graft GvHD prophylaxi... Primary antifun...	18 Years -	IRCCS San Raffaele

Spots Global Cancer Trial Database for primary antifungal prophylaxis