Peripheral Blood Stem Cell Transplantation From Family Haploidentical Donors in Patients With Myelodysplastic Syndrome and Acute Leukemia Under Primary Prophylaxis With Posaconazole (SIR-POSA)
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|ClinicalTrials.gov Identifier: NCT03434704|
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : September 9, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Transplant-Related Hematologic Malignancy Leukemia, Acute Myelodysplastic Syndromes Graft Vs Host Disease Fungal Infection||Drug: Conditioning treatment "Thiotepa-Treosulfan-Fludarabine" Procedure: PBSC graft Drug: GvHD prophylaxis Drug: Primary antifungal prophylaxis||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Actual Study Start Date :||June 18, 2018|
|Estimated Primary Completion Date :||March 15, 2020|
|Estimated Study Completion Date :||September 15, 2022|
Experimental: Single Arm Treatment
Conditioning treatment "Thiotepa-Treosulfan-Fludarabine"; PBSC graft; GvHD prophylaxis; Primary antifungal prophylaxis.
Drug: Conditioning treatment "Thiotepa-Treosulfan-Fludarabine"
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.
Other Name: TTF
Procedure: PBSC graft
(target 4-8 × 106 CD34+ cells/kg patient body weight)
Drug: GvHD prophylaxis
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.
Drug: Primary antifungal 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.
- Graft-versus-host disease-free, relapse-free survival (GRFS) [ Time Frame: 2 years ]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
- Efficacy of antifungal prophylaxis strategy [ Time Frame: 85 days after transplantation ]The rate of proven, probable and possible invasive fungal diseases documented within the first 85 days after transplantation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434704
|Contact: Fabio Ciceri, MD||0039022643 ext firstname.lastname@example.org|
|Ospedale San Raffaele||Recruiting|
|Milano, Lombardia, Italy, 20132|
|Contact: Fabio Ciceri, MD 0039022643 ext 4289 email@example.com|
|Sub-Investigator: Raffaella Greco, MD|
|Sub-Investigator: Jacopo Peccatori, MD|
|Sub-Investigator: Maria Teresa Lupo Stanghellini, MD|
|Sub-Investigator: Andrea Assanelli, MD|
|Sub-Investigator: Consuelo Corti, MD|