BridgeMD
New treatment option for Acute Myeloid Leukaemia (AML)
Official title 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
ClinicalTrials.gov ID: NCT06845592
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Availability of a hematopoietic stem cell donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with...
- Age ≥ 18 and ≤ 65 years
You likely can't join if
- AML patients
- AML in CR MRD-
- AML with \> 5% peripheral blasts or bone marrow infiltration ≥ 30%
- Age \ 65 years
- ECOG \> 2
- Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment
See the full eligibility 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...
- 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...
- Age ≥ 18 and ≤ 65 years
- ECOG ≤ 2
- HCT-CI ≤ 4
- Absence of relevant psychiatric diseases
- Signature of the informed consent
- AML patients
- AML in CR MRD-
- AML with \> 5% peripheral blasts or bone marrow infiltration ≥ 30%
- Age \ 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 \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Perugia, PG, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Perugia, PG, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.