NCT03270748

Brief Summary

The experimental treatment consists in the application of a therapeutic strategy with post Transplant High-Dose Cyclophosphamide as GvHD Prophylaxis in Patients Receiving 1-Antigen/Allele HLA Mismatched (7/8 matched) Unrelated Hemopoietic Stem Cell Transplantation for Myeloid Malignancies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2020

Typical duration for phase_2

Geographic Reach
1 country

33 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
2.4 years until next milestone

Study Start

First participant enrolled

January 15, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2022

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

2.8 years

First QC Date

August 24, 2017

Last Update Submit

March 9, 2023

Conditions

Myeloid Malignancies

Keywords

Allogeneic hematopoietic stem cell transplantationacute graft-versus-host diseaseUnrelated donorsPost-transplant cyclophosphamideMyeloid Malignanciesunrelated hematopoietic cell transplantationGITMO

Outcome Measures

Primary Outcomes (1)

  • incidence of acute GvHD

    cumulative incidence of acute GvHD (grade II-IV) at 100 days post Unrelated Hemopoietic Stem Cell Transplantation

    day +100 post-transplant

Secondary Outcomes (8)

  • Overall survival

    1 year post transplantation

  • GRFS (GvHD free, relapse free survival)

    first 12 months after transplantation

  • chronic graft-versus-host disease

    3 years from transplantation

  • Graft failure

    day +100 and 1 year after transplantation

  • Haematopoietic Recovery

    participants will be followed for the duration of hospital stay, an expected average of 30 days

  • +3 more secondary outcomes

Study Arms (1)

Experimental

EXPERIMENTAL

Experimental: Experimental The experimental consists in the application of a therapeutic strategy: post Transplant High-Dose Cyclophosphamide as GvHD Prophylaxis in Patients Receiving 1-Antigen/Allele HLA Mismatched (7/8 matched) Unrelated Hemopoietic Stem Cell Transplantation for Myeloid Malignancies Therapeutic intervention, namely conditioning regimen and GVHD prophylaxis, are based on standard current regimens: Busulfan 0,8 mg/kg 4 times per day during 2 h infusions for 4 consecutive days (from day -6 through day -3) Fludarabine 40 mg/m2 per day for 4 days (from day -6 through day -3); GvHD prophylaxis: Cyclosporine or Tacrolimus beginning day+5 up to at least 100 days. Micofenolate 15mg/kg twice a day from day +5 to +35.

Drug: GvHD prophylaxis

Interventions

GvHD prophylaxisDRUG

Cyclophosphamide 50 mg/kg intravenously day+3 and +4 (total dose:100 mg/kg).

Experimental

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute myeloid leukemia in complete remission Myelodysplastic syndrome Indication for allo-HCT No available HLA identical sibling donor or HLA matched unrelated donor Activation of an alternative donor search Presence of a 1 antigen/allele mismatched (7/8 HLA matched) unrelated donor ECOG performance status \<2 Written and signed informed consent

You may not qualify if:

  • left ventricular ejection fraction \< 40% FEV1, FVC, DLCO \<50% of predicted LFT \> 5 times the upper limit of normal creatinine clearance \< 40 ml/min Previous allogeneic Hemopoietic Stem Cell Transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Azienda Ospedaliera SS Antonio e Biagio

Alessandria, Italy

Location

Ospedali Riuniti

Ancona, Italy

Location

Ospedale Moscati

Avellino, Italy

Location

Policlinico di Bari-Ematologia con trapianti

Bari, Italy

Location

Divisione di Ematologia - Ospedali Papa Giovanni XXIII

Bergamo, Italy

Location

Ospedale San Orsola

Bologna, Italy

Location

Ospedale Regionale Generale- Divisione Ematologia

Bolzano, Italy

Location

ASST Spedali Civili

Brescia, Italy

Location

Ospedale Binaghi

Cagliari, Italy

Location

S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle

Cuneo, Italy

Location

Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza

Foggia, Italy

Location

AOU-IRCCS San Martino-IST

Genova, Italy

Location

Osp. Card. Panico

Lecce, Italy

Location

AOU Integrata

Mestre, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

Ospedale Niguarda Ca' Grande

Milan, Italy

Location

Divisione Ematologia - Azienda Ospedaliera Universitaria - Policlinico -

Modena, Italy

Location

ASST Ospedale S. Gerardo de' i Tintori - Università degli Studi di Milano

Monza, Italy

Location

A.O.U. Policlinico Federico II

Napoli, Italy

Location

Azienda ospedaliera Universitaria di Parma

Parma, Italy

Location

Fondazione IRCCS San Matteo

Pavia, 27100, Italy

Location

Ospedale G. Da Saliceto di Piacenza

Piacenza, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Location

Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli

Reggio Calabria, Italy

Location

A.O. San Camillo Forlanini

Roma, Italy

Location

Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli

Roma, Italy

Location

Policlinico Umberto I

Roma, Italy

Location

Az. Ospedaliera Universitaria Senese - Divisione Ematologia e Trapianti

Siena, Italy

Location

Ospedale Moscati

Taranto, Italy

Location

A.O.U. Citta della Salute e della Scienza

Torino, Italy

Location

Ospedale Gonzaga

Torino, Italy

Location

A.O. Santa Maria della Misericordia

Udine, Italy

Location

Ospedale S. Bortolo-Divisione Ematologia

Vicenza, Italy

Location

Related Publications (1)

  • Raiola AM, Bruno B, Risitano AM, Mosna F, Cavattoni IM, Onida F, Saporiti G, Patriarca F, Battista ML, Pavone V, Mele A, Chiusolo P, Sica S, Loteta B, di Grazia C, Carella AM, Salvatore D, Morello E, Leoni A, Giaccone L, Bernasconi P, Terruzzi E, Mordini N, Borghero C, Zallio F, Luppi M, Grassi A, Olivieri A, Piras E, Sacchi N, Ciccone G, Castiglione A, Degrandi E, Angelucci E, Martino M, Bonifazi F. Posttransplant cyclophosphamide as GVHD prophylaxis in patients receiving mismatched unrelated HCT: the PHYLOS trial. Blood Adv. 2025 Apr 22;9(8):1966-1975. doi: 10.1182/bloodadvances.2024015173.

    PMID: 39928954DERIVED

Study Officials

  • Annamaria Raiola, MD

    Ospedale Policlinico San Martino-IST

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2017

First Posted

September 1, 2017

Study Start

January 15, 2020

Primary Completion

November 20, 2022

Study Completion

November 20, 2022

Last Updated

March 10, 2023

Record last verified: 2023-03

Locations

IT(33)