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

Ciceri Fabio

Status and phase: Completed; Phase 2

Conditions: Fungal Infection; Graft Vs Host Disease; Transplant-Related Hematologic Malignancy; Leukemia, Acute; Myelodysplastic Syndromes

Treatments: Drug: Conditioning treatment "Thiotepa-Treosulfan-Fludarabine"; Drug: GvHD prophylaxis; Procedure: PBSC graft; Drug: Primary antifungal prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT03434704

2017-004423-78

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Single Arm Treatment

Experimental group

Description:

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

Treatment:

Drug: Primary antifungal prophylaxis

Procedure: PBSC graft

Drug: GvHD prophylaxis

Drug: Conditioning treatment "Thiotepa-Treosulfan-Fludarabine"