Status:

COMPLETED

Post Transplant High-Dose Cy as GvHD Prophylaxis in 1 HLA Mismatched Unrelated HSCT for Myeloid Malignancies

Lead Sponsor:

Gruppo Italiano Trapianto di Midollo Osseo

Conditions:

Myeloid Malignancies

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

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 Mismatch...

Detailed Description

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 Mismatch...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

January 15 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 20 2022

Estimated Enrollment :

78 Patients enrolled

Trial Details

Trial ID

NCT03270748

Start Date

January 15 2020

End Date

November 20 2022

Last Update

March 10 2023

Active Locations (33)

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Page 1 of 9 (33 locations)

1

Azienda Ospedaliera SS Antonio e Biagio

Alessandria, Italy

2

Ospedali Riuniti

Ancona, Italy

3

Ospedale Moscati

Avellino, Italy

4

Policlinico di Bari-Ematologia con trapianti

Bari, Italy