Clinical trial • Phase II • Haematology

Treosulfan for Acute myeloid leukemia

Phase II trial of Treosulfan for Acute myeloid leukemia. None/Not specified-controlled. 82 participants.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Acute myeloid leukemia
Trial Stage
Phase II
Drug Modality
Small molecule|Other antibody

Key dates

Initial CTIS Submission Date
09-01-2025
First CTIS Authorization Date
31-01-2025

Trial design

None/Not specified-controlled Phase II trial in Italy.

Comparator
None/Not specified
Target Sample Size
82

Eligibility

Recruits 82 No vulnerable populations selected. Participants must provide written and signed informed consent. Multiple subject information and informed consent forms are listed (e.g. 'CONSENSO v11 02052022', 'modulo informativa brescia v 11 del 02052022'); no paediatric assent procedures (trial enrols adults >40 years)..

Pregnancy Exclusion
Pregnant or lacting patients during screening
Vulnerable Population
No vulnerable populations selected. Participants must provide written and signed informed consent. Multiple subject information and informed consent forms are listed (e.g. 'CONSENSO v11 02052022', 'modulo informativa brescia v 11 del 02052022'); no paediatric assent procedures (trial enrols adults >40 years).

Inclusion criteria

  • {"criterion_text":"-Patients >40 <65 years of age"}
  • {"criterion_text":"-Diagnosis of AML in first CR/CRi/ MLFS"}
  • {"criterion_text":"-Eligible for allo-SCT from HLA-identical matched related or unrelated donor as defined by molecular high-resolution typing (4 digits) at the following four HLA gene loci (HLA-A, B, C, and DRB1)"}
  • {"criterion_text":"-Adequate hepatic function (bilirubin ≤2 UNL; ALT/AST ≤2,5 UNL)"}
  • {"criterion_text":"-Adequate renal function (creatinine clearance ≥50 ml/min)"}
  • {"criterion_text":"-ECOG Performance Status < 2"}
  • {"criterion_text":"-Willing and able to comply with all of the requirements and visits in the protocol"}
  • {"criterion_text":"-Written and signed informed consent"}

Exclusion criteria

  • {"criterion_text":"-AML patients with t(15;17); t(8;21); inv(16)"}
  • {"criterion_text":"-Participation in another clinical trial within 1 month before the start of this trial"}
  • {"criterion_text":"-Participant, both female and male, in childbearing age who do not agree to maintain active contraceptive practice"}
  • {"criterion_text":"-Pregnant or lacting patients during screening"}
  • {"criterion_text":"-Subject has known active CNS involvement with AML"}
  • {"criterion_text":"-Grade >2 NCI-CTCAE (v. 5) adverse events at the time of enrollment"}
  • {"criterion_text":"-Serious organ dysfunction: left ventricular ejection fraction < 40%, FEV1, FVC, DLCO (diffusion capacity) <40% of predicted, LFT > 5 times the upper limit of normal, or creatinine clearance < 40 ml/min"}
  • {"criterion_text":"-The evidence of HBV or HCV active infection (HBV DNA, HCV RNA positive test)"}
  • {"criterion_text":"-Patients with HIV infection"}
  • {"criterion_text":"-Current uncontrolled infections"}
  • {"criterion_text":"-Patients with other life-threatening concurrent disease"}
  • {"criterion_text":"-Subjects with known hypersensitivity to any of the component medication"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-The 1-year leukemia -free survival (LFS) after allo-SCT","definition_or_measurement_approach":"Leukemia-free survival measured at 1 year after allogeneic stem cell transplantation (allo-SCT)."}

Recruitment

Planned Sample Size
82
Recruitment Window Months
36
Consent Approach
Written and signed informed consent required from each participant. Subject information and informed consent forms are listed among documents (e.g. 'CONSENSO v11 02052022', 'modulo informativa brescia v 11 del 02052022'); no assent/paediatric consent procedures described; languages not specified.

Geography

Total Number Of Sites
17
Total Number Of Participants
82

Italy

Earliest CTIS Part Ii Submission Date
20-12-2024
Latest Decision Or Authorization Date
31-01-2025
Processing Time Days
42
Number Of Sites
17
Number Of Participants
82

Sites

Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Clinica Ematologica
Principal Investigator Name
Francesca Patriarca
Principal Investigator Email
francesca.patriarca@uniud.it
Contact Person Name
Francesca Patriarca
Contact Person Email
francesca.patriarca@uniud.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
SOD TERAPIE CELLULARI E MEDICINA TRASFUSIONALE
Principal Investigator Name
Riccardo Saccardi
Principal Investigator Email
riccardo.saccardi@aouc.unifi.it
Contact Person Name
Riccardo Saccardi
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
U.O.S.D. Oncologia Medica
Principal Investigator Name
Francesco Onida
Principal Investigator Email
FRANCESCO.ONIDA@UNIMI.IT
Contact Person Name
Francesco Onida
Contact Person Email
FRANCESCO.ONIDA@UNIMI.IT
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
BMT unit
Principal Investigator Name
Paola Bresciani
Principal Investigator Email
ricercainnovazione@aou.mo.it
Contact Person Name
Paola Bresciani
Contact Person Email
ricercainnovazione@aou.mo.it
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
Department Name
SOC della Clinica di Ematologia
Principal Investigator Name
Attilio Olivieri
Principal Investigator Email
a.olivieri@staff.univpm.it
Contact Person Name
Attilio Olivieri
Contact Person Email
a.olivieri@staff.univpm.it
Site Name
Azienda Ulss 3 Serenissima
Department Name
UOC Ematologia
Principal Investigator Name
Cristina Skert
Principal Investigator Email
michela.zanutti@aulss3.veneto.it
Contact Person Name
Cristina Skert
Site Name
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Department Name
Onco-Ematologico e Radioterapico
Principal Investigator Name
Massimo Martino
Principal Investigator Email
massimo.martino@ospedalerc.it
Contact Person Name
Massimo Martino
Contact Person Email
massimo.martino@ospedalerc.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
U.O. Ematologia
Principal Investigator Name
Elisabetta Terruzzi
Principal Investigator Email
marina.cazzaniga@unimib.it
Contact Person Name
Elisabetta Terruzzi
Contact Person Email
marina.cazzaniga@unimib.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
Divisione di Ematologia
Principal Investigator Name
Fabio Benedetti
Principal Investigator Email
ufficio.protocollo@aovr.veneto.it
Contact Person Name
Fabio Benedetti
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC EMATOLOGIA E TRAPIANTI DI CSE
Principal Investigator Name
Simona Sica
Principal Investigator Email
simona.sica@unicatt.it
Contact Person Name
Simona Sica
Contact Person Email
simona.sica@unicatt.it
Site Name
Azienda Ospedaliera Santa Croce E Carle
Department Name
BMT Program
Principal Investigator Name
Nicola Mordini
Principal Investigator Email
mordinin@gmail.com
Contact Person Name
Nicola Mordini
Contact Person Email
mordinin@gmail.com
Site Name
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Department Name
U.O.C. Ematologia con trapianti di cellule staminali ematopoietiche (CSE) e Terapia Intensiva
Principal Investigator Name
Alessandra Picardi
Principal Investigator Email
alessandra.picardi@aocardarelli.it
Contact Person Name
Alessandra Picardi
Site Name
Azienda Sanitaria Territoriale Di Ascoli Piceno
Department Name
U.O.C. Ematologia
Principal Investigator Name
Piero Galieni
Principal Investigator Email
piero.galieni@sanita.marche.it
Contact Person Name
Piero Galieni
Contact Person Email
piero.galieni@sanita.marche.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Ematologia
Principal Investigator Name
Giuseppe Milone
Principal Investigator Email
giuseppe.milone@gmail.com
Contact Person Name
Giuseppe Milone
Contact Person Email
giuseppe.milone@gmail.com
Site Name
Ospedale S. Eugenio
Department Name
Ematologia
Principal Investigator Name
Paolo De Fabritiis
Principal Investigator Email
paolo.de.fabritiis@uniroma2.it
Contact Person Name
Paolo De Fabritiis
Contact Person Email
paolo.de.fabritiis@uniroma2.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Centro Trapianto Midollo Osseo Adulti
Principal Investigator Name
Domenico Russo
Principal Investigator Email
clinicaltrialcenter@asst-spedalicivili.it
Contact Person Name
Domenico Russo
Site Name
Istituto San Raffaele
Department Name
U. O. di Ematologia e Trapianto Midollo Osseo (UTMO)
Principal Investigator Name
Fabio Ciceri
Principal Investigator Email
ciceri.fabio@hsr.it
Contact Person Name
Fabio Ciceri
Contact Person Email
ciceri.fabio@hsr.it

Sponsor

Primary sponsor

Full Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
Treosulfan Tillomed 5g polvere per soluzione per infusione
Active Substance
Treosulfan
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
14 mg/m2 (max daily)
Investigational Product Name
FLUDARABINE TEVA 25 mg/ml, solution à diluer pour injectable ou perfusion
Active Substance
Fludarabine phosphate
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION/INJECTION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
30 mg/m2 (max daily)
Combination Treatment
Yes

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