Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fungal Infection | — | UNRESOLVED | — |
| Graft Vs Host Disease | — | UNRESOLVED | — |
| Leukemia, Acute | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Transplant-Related Hematologic Malignancy | Transplant-Related Hematologic Malignancy | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conditioning treatment "Thiotepa-Treosulfan-Fludarabine" | Drug | — | UNRESOLVED |
| GvHD prophylaxis | Drug | — | UNRESOLVED |
| PBSC graft | Procedure | — | UNRESOLVED |
| Primary antifungal prophylaxis | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm Treatment
- description
- Conditioning treatment "Thiotepa-Treosulfan-Fludarabine"; PBSC graft; GvHD prophylaxis; Primary antifungal prophylaxis.
- interventionNames
- Drug: Conditioning treatment "Thiotepa-Treosulfan-Fludarabine"
- Procedure: PBSC graft
- Drug: GvHD prophylaxis
- Drug: Primary antifungal prophylaxis
Primary outcomes (1)
- measure
- Graft-versus-host disease-free, relapse-free survival (GRFS)
- timeFrame
- 2 years
- description
- 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
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of myelodysplastic syndromes or acute leukemia * Activation of an alternative donor search by the Italian Bone Marrow Donor Registry (IBMDR) with absence of a 10/10 Human Leukocyte Antigens (HLA) matched unrelated donor * Age \>18 * Unavailability of a HLA-matched related donor (MRD) * Performance status : Eastern Cooperative Oncology Group (ECOG) \<3 * Written and signed informed consent * Life expectancy not severely limited by concomitant illness. Exclusion Criteria: * Women of child-bearing potential who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective method of birth control such as condoms, implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), vasectomised partner on treatment and for at least 6 months thereafter. * Pregnant or nursing (lactating) women. * Known allergies, hypersensitivity, or intolerance to any experimental drugs. * Any active, uncontrolled infection.
References
Publications (0)
Data not yet available