Allogeneic HSCT in MDS Patients Based on Risk According to R-IPSS

Allogeneic Transplantation in Patients With Myelodysplastic Syndrome Based on Risk According to Revised-International Prognostic Scoring System (R-IPSS)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04801563

Enrollment

Registered

2021-03-17

Start date

2019-09-20

Completion date

2025-09-19

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MDS and Allogeneic Stem Cell Transplantation

Brief summary

An intention-to-treat study to evaluate the impact of allogeneic HSCT with Total Marrow and Lymphoid irradiation (TMLI), followed by Treg/Tcon adoptive immunotherapy, on overall survival in patients affected by Myelodysplastic Syndrome (MDS), according to IPSS-R.

Detailed description

MDS patients with Intermediate, High, or Very-High R-IPSS risk will be enrolled. Allogeneic stem cell transplantation with regulatory and conventional T cell adoptive immunotherapy will be proposed to eligible High and Very-High risk MDS patients. Intermediate risk MDS patients will be assessed for risk modification every six months and moved to transplant in case of increased risk. Intermediate risk MDS patients will be also evaluated for the presence of molecular alterations (TP53, ASXL1, RUNX1). Overall survival of the entire cohort will be assessed as primary endpoint. Incidence of Treatment Related Mortality, acute Graft versus Host Disease, chronic Graft versus Host Disease, Relapse will be also assessed.

Interventions

OTHERMDS and AlloHSCT

Allogeneic stem cell transplantation, based on TMLI and followed by infusion of donor regulatory T cells and conventional T cells and purified donor CD34+ hematopoietic stem cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 70 Years

Healthy volunteers

Inclusion criteria

* Patients affected by Myelodysplastic Syndrome with IPSS-R INT, HIGH or VERY HIGH; * Age \<71 years; * Signature of the informed consent.

Exclusion criteria

* Patients affected by Myelodysplastic Syndrome with IPSS-R VERY LOW or LOW; * Patients affected by Myelodysplastic Syndrome/Myeloproliferative Neoplasm; * Age \>70 years; * No signature of the informed consent

Design outcomes

Primary

Measure	Time frame	Description
overall survival	4 years	We will evaluate overall survival in patients with intermediate/High/very-High risk MDS

Countries

Italy

Contacts

Primary ContactAntonio Pierini, MD

antonio.pierini@unipg.it+390755784147

Backup ContactMara Merluzzi, MBiotech

maramerluzzi@libero.it+393482200239

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026