Phase II trial of peripheral blood stem cell transplantation from a partially compatible family donor in patients with a blood tumor (myelodysplasia and leukemia) treated for the prevention of fungal infections with posaconazole

Phase 1

• Conditions: Myelodisplastic Syndrome (MDS) and AcuteLeukemia; MedDRA version: 20.0Level: LLTClassification code 10028532Term: MyelodysplasiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 21.0Level: LLTClassification code 10024289Term: Leukaemia acuteSystem Organ Class: 100000004864

• Registration Number: EUCTR2017-004423-78-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-03
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 82

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 HLA matched unrelated donor
• Age >18
•Unavailability of a HLA-matched related donor (MRD)
•Performance status : ECOG = 3
•Written and signed informed consent
•Life expectancy not severely limited by concomitant illness.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

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, IUDs (intrauterine devices), 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified