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

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.

Sponsors

Lead Sponsor: Ciceri Fabio

Source IRCCS San Raffaele
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 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.

Overall Status Recruiting
Start Date 2018-06-18
Completion Date 2022-09-15
Primary Completion Date 2020-03-15
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Graft-versus-host disease-free, relapse-free survival (GRFS) 2 years
Secondary Outcome
Measure Time Frame
Efficacy of antifungal prophylaxis strategy 85 days after transplantation
Enrollment 82
Condition
Intervention

Intervention Type: Drug

Intervention Name: Conditioning treatment "Thiotepa-Treosulfan-Fludarabine"

Description: 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.

Arm Group Label: Single Arm Treatment

Other Name: TTF

Intervention Type: Procedure

Intervention Name: PBSC graft

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

Arm Group Label: Single Arm Treatment

Intervention Type: Drug

Intervention Name: GvHD prophylaxis

Description: 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.

Arm Group Label: Single Arm Treatment

Intervention Type: Drug

Intervention Name: Primary antifungal prophylaxis

Description: 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.

Arm Group Label: Single Arm Treatment

Eligibility

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Fabio Ciceri, MD

Phone: 0039022643

Phone Ext.: 4289

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Ospedale San Raffaele Fabio Ciceri, MD 0039022643 4289 [email protected] Raffaella Greco, MD Sub-Investigator Jacopo Peccatori, MD Sub-Investigator Maria Teresa Lupo Stanghellini, MD Sub-Investigator Andrea Assanelli, MD Sub-Investigator Consuelo Corti, MD Sub-Investigator
Location Countries

Italy

Verification Date

2019-09-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: IRCCS San Raffaele

Investigator Full Name: Ciceri Fabio

Investigator Title: MD

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Single Arm Treatment

Type: Experimental

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

Acronym SIR-POSA
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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