Prospective Phase II study on Safety and Efficacy of Fludarabine plus Treosulfan (14g) (FT14) conditioning regimen for allogeneic Stem Cell Transplantation (allo-SCT) in Acute Myeloid Leukemia (AML) patients (≥40 <65years)

Status Authorised, recruitment pending · 1 EU/EEA countries · 17 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Authorised, recruitment pending

Participants planned 82

Countries 1

Sites 17

Acute Myeloid Leukemia (AML)

To evaluate the safety and efficacy of the FT14 conditioning regimen for allo-SCT in AML patients (≥40 <65years) in complete morphological remission (CR/CRi/MLFS)

Key facts

Sponsor: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Participant type: Patients
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
Decision date (initial): 2025-01-31
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2024-520326-11-00
EudraCT number: 2022-003206-69

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

To evaluate the safety and efficacy of the FT14 conditioning regimen for allo-SCT in AML patients (≥40 <65years) in complete morphological remission (CR/CRi/MLFS)

Conditions and MedDRA coding

Acute Myeloid Leukemia (AML)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

Patients >40 <65 years of age
Diagnosis of AML in first CR/CRi/ MLFS
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)
Adequate hepatic function (bilirubin ≤2 UNL; ALT/AST ≤2,5 UNL)
Adequate renal function (creatinine clearance ≥50 ml/min)
ECOG Performance Status < 2
Willing and able to comply with all of the requirements and visits in the protocol
Written and signed informed consent

Exclusion criteria 12

AML patients with t(15;17); t(8;21); inv(16)
Subject has known active CNS involvement with AML
Grade >2 NCI-CTCAE (v. 5) adverse events at the time of enrollment
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
The evidence of HBV or HCV active infection (HBV DNA, HCV RNA positive test)
Patients with HIV infection
Current uncontrolled infections
Patients with other life-threatening concurrent disease
Subjects with known hypersensitivity to any of the component medication
Participation in another clinical trial within 1 month before the start of this trial
Participant, both female and male, in childbearing age who do not agree to maintain active contraceptive practice
Pregnant or lacting patients during screening

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

The 1-year leukemia -free survival (LFS) after allo-SCT

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Treosulfan Tillomed 5g polvere per soluzione per infusione

PRD6195119 · Product

Active substance: Treosulfan
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INFUSION
Max daily dose: 14 mg/m2 milligram(s)/sq. meter
Max total dose: 30 gm/m2 gram(s)/square meter
Max treatment duration: 3 Day(s)
Authorisation status: Authorised
ATC code: L01AB02 — TREOSULFAN
Marketing authorisation: 045918012
MA holder: TILLOMED ITALIA S.R.L.
MA country: Italy
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

FLUDARABINE TEVA 25 mg/ml, solution à diluer pour injectable ou perfusion

PRD732061 · Product

Active substance: Fludarabine Phosphate
Pharmaceutical form: INJECTION
Route of administration: INFUSION
Max daily dose: 30 mg/m2 milligram(s)/square meter
Max total dose: 150 mg/m2 milligram(s)/square meter
Max treatment duration: 5 Day(s)
Authorisation status: Authorised
ATC code: L01BB05 — FLUDARABINE
Marketing authorisation: NL32376
MA holder: TEVA SANTÉ
MA country: France
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Auxiliary 4

Ciclosporin

SCP138048 · ATC

Active substance: Ciclosporin
Substance synonyms: CYCLOSPORIN A, CYCLOSPORINE, CICLOSPORINE, CYCLOSPORIN
Route of administration: PARENTERAL USE
Max daily dose: 3.5 mg/Kg milligram(s)/kilogram
Max total dose: 52.5 mg/Kg milligram(s)/kilogram
Max treatment duration: 2 Week(s)
Authorisation status: Authorised
ATC code: L04AD01 — CICLOSPORIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Mycophenolic Acid

SCP172157 · ATC

Active substance: Mycophenolic Acid
Substance synonyms: MYCOPHENOLATE
Route of administration: INFUSION
Max daily dose: 2.5 mg/Kg milligram(s)/kilogram
Max total dose: 10 mg/Kg milligram(s)/kilogram
Max treatment duration: 4 Day(s)
Authorisation status: Authorised
ATC code: L04AA04 — ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT)
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate Sodium

SCP10339494 · ATC

Active substance: Methotrexate Sodium
Substance synonyms: SODIUM METHOTREXATE, MTX SODIUM
Route of administration: INFUSION
Max daily dose: 30 mg milligram(s)
Max total dose: 150 mg milligram(s)
Max treatment duration: 5 Day(s)
Authorisation status: Authorised
ATC code: L01BA01 — METHOTREXATE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Grafalon 20 mg/ml concentrato per soluzione per infusione

PRD3161259 · Product

Active substance: Anti-T Lymphocyte Immunoglobulin for Human Use, Rabbit
Substance synonyms: LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN, RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN, ANTI-HUMAN THYMOCYTE IMMUNOGLOBULIN, RABBIT
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INFUSION
Max daily dose: 20 mg/Kg milligram(s)/kilogram
Max total dose: 60 mg/Kg milligram(s)/kilogram
Max treatment duration: 3 Day(s)
Authorisation status: Authorised
ATC code: L04AA04 — ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT)
Marketing authorisation: 042421026
MA holder: NEOVII BIOTECH GMBH
MA country: Italy
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Sponsor organisation: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Address: Piazzale Spedali Civili 1
City: Brescia
Postcode: 25123
Country: Italy

Scientific contact point

Organisation: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Contact name: S.C. Clinical Trial Center

Public contact point

Organisation: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Contact name: S.C. Clinical Trial Center

Locations

1 EU/EEA country · 17 investigational sites

By country

Country	MS status	Planned subjects	Sites
Italy	Authorised, recruitment pending	82	17
Rest of world	—	0	—

Investigational sites

Italy

17 sites · Authorised, recruitment pending

Azienda Ospedaliera Universitaria Integrata Verona

Divisione di Ematologia, Piazzale Aristide Stefani 1, 37126, Verona

Azienda Ulss 3 Serenissima

UOC Ematologia, Mestre-Venezia, Via Don Federico Tosatto 147, Venice

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

UOC EMATOLOGIA E TRAPIANTI DI CSE, Largo Francesco Vito 1, 00168, Rome

Grande Ospedale Metropolitano Bianchi Melacrino Morelli

Onco-Ematologico e Radioterapico, Viale Europa, 89133, Reggio Calabria

Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli

U.O.C. Ematologia con trapianti di cellule staminali ematopoietiche (CSE) e Terapia Intensiva, Via Antonio Cardarelli 9, 80131, Naples

Fondazione IRCCS San Gerardo Dei Tintori

U.O. Ematologia, Via Giovanni Battista Pergolesi 33, 20900, Monza

Azienda Ospedaliero Universitaria Di Modena

BMT unit, Via Pietro Giardini 1355, 41126, Modena

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

U.O.S.D. Oncologia Medica, Via Francesco Sforza 35, 20122, Milan

Azienda Ospedaliero Universitaria Careggi

SOD TERAPIE CELLULARI E MEDICINA TRASFUSIONALE, Largo Giovanni Alessandro Brambilla 3, 50134, Florence

Azienda Ospedaliera Santa Croce E Carle

BMT Program, Via Michele Coppino 26, 12100, Cuneo

Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi

SOC della Clinica di Ematologia, Via Filippo Corridoni 11, 60123, Ancona

Azienda Sanitaria Universitaria Friuli Centrale

Clinica Ematologica, Piazzale Santa Maria Della Misericordia 15, 33100, Udine

Ospedale S. Eugenio

Ematologia, Piazzale dell’ Umanesimo 10, 00144, Roma

Azienda Sanitaria Territoriale Di Ascoli Piceno

U.O.C. Ematologia, Via Degli Iris 1, 63100, Ascoli Piceno

Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania

Ematologia, Via Santa Sofia 78, 95123, Catania

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Centro Trapianto Midollo Osseo Adulti, Piazzale Spedali Civili 1, 25123, Brescia

Istituto San Raffaele

U. O. di Ematologia e Trapianto Midollo Osseo (UTMO), Via Olgettina 58, 20132, Milan

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	protocol v del 16 march 2022	1.1
Recruitment arrangements (for publication)	INTENTIONALLY LEFT BLANK	1
Subject information and informed consent form (for publication)	CONSENSO v11 02052022	1.1
Subject information and informed consent form (for publication)	lettera MMG	1.0
Subject information and informed consent form (for publication)	modulo informativa brescia v 11 del 02052022	1.1
Subject information and informed consent form (for publication)	privacy Sperimentazioni cliniche interne ASST	1.1
Summary of Product Characteristics (SmPC) (for publication)	Attachment I RCP Treo	1
Summary of Product Characteristics (SmPC) (for publication)	fludarabina RCP 25mg	1
Synopsis of the protocol (for publication)	Synopsis v 16 March2022	1.1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-01-09	Italy	Acceptable 2025-01-23	2025-01-31

Prospective Phase II study on Safety and Efficacy of Fludarabine plus Treosulfan (14g) (FT14) conditioning regimen for allogeneic Stem Cell Transplantation (allo-SCT) in Acute Myeloid Leukemia (AML) patients (≥40 <65years)

Overview

Key facts

External identifiers

Trial design

Main objective

Conditions and MedDRA coding

Eligibility criteria

Inclusion criteria 8

Exclusion criteria 12

Endpoints

Primary endpoints 1

Investigational products

Test 2

Auxiliary 4

Sponsors and contacts

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Scientific contact point

Public contact point

Locations

By country

Investigational sites

Results and documents

Documents 9 files

Application history

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