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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-20

Study Completion Date

2025-09-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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MDS and Allogeneic Stem Cell Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SINGLE ARM

Group Type OTHER

MDS and AlloHSCT

Intervention Type OTHER

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

Interventions

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MDS 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

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No