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

MDS and Allogeneic Stem Cell Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04801563
• Other study ID #: 03/19
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: September 19, 2025

Study information

• Verified date: March 2021
• Source: University Of Perugia
• Contact: Antonio Pierini, MD
• Phone: +390755784147
• Email: antonio.pierini[@]unipg.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 19, 2025
• Est. primary completion date: September 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• MDS and Allogeneic Stem Cell Transplantation

Intervention

Other:
• 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

Locations

Country	Name	City	State
Italy	University of Perugia	Perugia	PG

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Di Ianni M, Falzetti F, Carotti A, Terenzi A, Castellino F, Bonifacio E, Del Papa B, Zei T, Ostini RI, Cecchini D, Aloisi T, Perruccio K, Ruggeri L, Balucani C, Pierini A, Sportoletti P, Aristei C, Falini B, Reisner Y, Velardi A, Aversa F, Martelli MF. Tr — View Citation

Martelli MF, Di Ianni M, Ruggeri L, Falzetti F, Carotti A, Terenzi A, Pierini A, Massei MS, Amico L, Urbani E, Del Papa B, Zei T, Iacucci Ostini R, Cecchini D, Tognellini R, Reisner Y, Aversa F, Falini B, Velardi A. HLA-haploidentical transplantation with — View Citation

Outcome

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