Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia

NCT ID: NCT06845592

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2031-01-31

Brief Summary

The study is a monocentric, interventional study that evaluates the efficacy of allogeneic HLA-matched or haploidentical transplantation consisting of an irradiation-based conditioning regimen coupled with donor Treg/Tcon adoptive immunotherapy for high-risk acute leukemia patients.

Conditions

Acute Myeloid Leukaemia (AML); Acute Lymphoblastic Leukemia ALL; High Risk Leukaemia; Leukaemia Relapse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TMLI based contioning and Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation

All enrolled patients will receive a 20Gy-TMLI based conditioning regimen followed by the infusion of donor graft and Treg/Tcon adoptive immunotherapy

Group Type: EXPERIMENTAL

total marrow/lymphoid irradiation

Intervention Type: RADIATION

Combination of 20 Gy TMLI with Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation

Interventions

total marrow/lymphoid irradiation

Combination of 20 Gy TMLI with Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• AML patients

• Diagnosis of AML with indication to allogeneic hematopoietic cell transplantation.
• Diagnosis of adverse genetic risk leukemia or presence of MRD or active disease (bone marrow infiltration 5-30%) at the time of the transplant procedure.
• Availability of a hematopoietic stem cell donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.
• Age ≥ 18 and ≤ 65 years
• ECOG ≤ 2
• HCT-CI ≤ 4 (51,52)
• Absence of relevant psychiatric diseases
• Signature of the informed consent

ALL patients

• Diagnosis of ALL, either T or B (Philadelphia negative) or mixed phenotype with indication to allogeneic transplant
• Presence of MRD or active disease (bone marrow infiltration 5-30%) or patient with ≥ 2nd complete hematologic remission at the time of the transplant procedure.
• Availability of a hematopoietic stem cell family donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.
• Age ≥ 18 and ≤ 65 years
• ECOG ≤ 2
• HCT-CI ≤ 4
• Absence of relevant psychiatric diseases
• Signature of the informed consent

Exclusion Criteria

• AML patients

• AML in CR MRD-
• AML with > 5% peripheral blasts or bone marrow infiltration ≥ 30%
• Age < 18 years or > 65 years
• ECOG > 2
• Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment
• Pregnancy
• No signature of the informed consent
• ALL patients

• ALL with > 5% peripheral blasts or bone marrow infiltration ≥30%
• Philadelphia positive ALL
• Age < 18 years or > 65 years
• ECOG > 2
• Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment
• Pregnancy
• No signature of the informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Of Perugia

OTHER

Sponsor Role: lead

Responsible Party

Antonio Pierini

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Università degli Studi di Perugia

Perugia, PG, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Antonio Pierini

Role: CONTACT

antonio.pierini@unipg.it

+393355477611 ext. +39

Loredana Ruggeri

Role: CONTACT

loredana.ruggeri@ospedale.perugia.it

+393388953982 ext. +39

Facility Contacts

Antonio Pierini, MD, PhD

Role: primary

antonio.pierini@unipg.it

3355477611

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Other Identifiers

SHARP

Identifier Type: -

Identifier Source: org_study_id