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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434704
|Contact: Fabio Ciceri, MD||0039022643 ext email@example.com|
|Ospedale San Raffaele||Recruiting|
|Milano, Lombardia, Italy, 20132|
|Contact: Fabio Ciceri, MD 0039022643 ext 4289 firstname.lastname@example.org|
|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|