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NCT Number: NCT03434704

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

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.

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Key information

Conditions

Transplant-Related Hematologic Malignancy Bacterial Infections and Mycoses Bone Marrow Diseases Fungal Infection Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Infections Leukemia Leukemia, Acute Mycoses Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conditioning treatment "Thiotepa-Treosulfan-Fludarabine"

Drug

Thiotepa iv 5 mg/kg/bid (total dose TD 10 mg/kg) day -3,-2; Treosulfan iv 14g/mq/day (TD 42 g/mq) as a single daily dose day -6, -5, -4; Fludarabine iv 30 mg/m2 (TD 150 mg/m2) day -6, -5, -4, -3, -2. Thiotepa TD 5 mg/kg and treosulfan TD 36 g/mq dose reduction according to age > 65 years.

Other names: TTF

PBSC graft

Procedure

(target 4-8 × 106 CD34+ cells/kg patient body weight)

GVHD Prophylaxis

Drug

Sirolimus orally, monitored two times a week to maintain a target therapeutic plasma level of 8-15 ng/ml from day +5.

Mycophenolate 15 mg/kg bid i.v. or per os day +5 through +28. Cyclophosphamide 50 mg/kg i.v. day +3+4. Mesna: >80% of the cyclophosphamide dose in 3 divided doses from day +3 daily through day +5.

Primary antifungal prophylaxis

Drug

Posaconazole delayed-release tablet [available in 100 mg tablets]: 300 mg twice daily on the first day followed by a maintenance dose of 300 mg once a day, starting on the day 0 to day 85.

Primary outcomes

  1. Graft-versus-host disease-free, relapse-free survival (GRFS)

    Time frame: 2 years

    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. Efficacy of antifungal prophylaxis strategy

    Time frame: 85 days after transplantation

    The rate of proven, probable and possible invasive fungal diseases documented within the first 85 days after transplantation

Sponsors and collaborators

Lead sponsor

Ciceri Fabio

Other

Registry information

Official study title

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.

Acronym: SIR-POSA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2018
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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