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

Not Applicable

Recruiting

• Conditions: MDS and Allogeneic Stem Cell Transplantation
• Interventions: Other: MDS and AlloHSCT

• Registration Number: NCT04801563
• Lead Sponsor: University Of Perugia

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.

Study Timeline

• Study Start: 2019-09-20
• Study First Submitted: 2021-02-28
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-11
• Last Update Submitted: 2021-03-11
• Study First Posted: 2021-03-17
• Last Update Posted: 2021-03-17
• Primary Completion: 2025-09-19
• Study Completion: 2025-09-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SINGLE ARM	MDS and AlloHSCT	-

Primary Outcome Measures

Name	Time	Method
overall survival	4 years	We will evaluate overall survival in patients with intermediate/High/very-High risk MDS

Trial Locations

Locations (1)

University of Perugia; 🇮🇹 Perugia, PG, Italy