Overview

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

Status:
Recruiting
Trial end date:
2022-09-15
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ciceri Fabio
Treatments:
Antifungal Agents
Busulfan
Clotrimazole
Fludarabine
Fludarabine phosphate
Miconazole
Posaconazole
Thiotepa
Treosulfan
Criteria
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.