Status:
COMPLETED
Peripheral Blood Stem Cell Transplantation From Family Haploidentical Donors in Patients With Myelodysplastic Syndrome and Acute Leukemia Under Primary Prophylaxis With Posaconazole
Lead Sponsor:
Ciceri Fabio
Conditions:
Transplant-Related Hematologic Malignancy
Leukemia, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03434704
Start Date
June 18 2018
End Date
October 13 2019
Last Update
July 19 2022
Active Locations (1)
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1
Ospedale San Raffaele
Milan, Lombardy, Italy, 20132