Irradiation-based Myeloablative Conditioning Followed by Treg/Tcon Immunotherapy in HSCT

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate if hyper-fractionated TBI or TMLI followed by Treg/Tcon adoptive immunotherapy improve cGvHD/disease free survival after allogeneic HSCT in patients affected by high-risk acute leukemias or other hematologic malignancy where HSCT is indicated.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06845592

Acute Myeloid Leukaemia (AML) Acute Lymphoblastic Leukemia ALL High Risk Leukaemia +1 more

RECRUITING NA

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

NCT04801563

MDS and Allogeneic Stem Cell Transplantation

UNKNOWN NA

Characterization of T-cell Repertoire in Patients With Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant

NCT03921047

Acute Myeloid Leukemia

RECRUITING

Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

NCT01529827

Accelerated Phase Chronic Myelogenous Leukemia Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Myeloid Leukemia in Remission +75 more

COMPLETED PHASE2

Allogenic Haematopoietic Cell Transplantation for Patients With Refractory "Triple Negative" Breast Cancer

NCT01375023

Breast Cancer

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Improving cGvHD/disease free survival in patients with high-risk acute leukemias or other hematologic malignancy where HSCT is indicated with the use of a regulatory T cell based protocol. Hyper-fractionated Total Body Irradiation or Total Marrow and Lymphoid Irradiation based conditioning will be followed by the infusion of T regulatory and T conventional cell adoptive immunotherapy and a purified CD34+ hematopoietic stem cell graft. Incidence of Non Relapse Mortality, Relapse, acute Graft versus Host Disease, chronic Graft versus Host Disease, as well as probability of cGvHD/disease free survival will be assessed in patient subpopulations separated according to HLA-matching with the donor (HLA-matched HSCT and HLA-haploidentical HSCT) and type of disease (acute myeloid leukemia, acute lymphoid leukemia, lymphoma, multiple myeloma, myeloproliferative disease, and other).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myeloid Leukemia Acute Lymphoid Leukemia Myeloproliferative Disorders Lymphoma Multiple Myeloma Other Hematologic Malignant Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High dose irradiation conditioning + Treg/Tcon

High dose irradiation based conditioning regimens followed by infusion of donor regulatory and conventional T cells and purified CD34+ hematopoietic stem cell transplantation

Group Type EXPERIMENTAL

High dose irradiation conditioning + Treg/Tcon

Intervention Type BIOLOGICAL

High dose irradiation based conditioning regimens followed by infusion of donor regulatory and conventional T cells and purified CD34+ hematopoietic stem cell transplantation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High dose irradiation conditioning + Treg/Tcon

High dose irradiation based conditioning regimens followed by infusion of donor regulatory and conventional T cells and purified CD34+ hematopoietic stem cell transplantation

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* AML and ALL in complete remission and with high-risk of relapse
* AML and ALL primarily chemoresistant or relapsed;
* Chronic Myeloid Leukemia in accelerated or blastic phase;
* Patients affected by

* Multiple myeloma,
* Non Hodgkin lymphoma,
* Hodgkin lymphoma,
* Chronic myeloproliferative syndrome,
* Chronic Lymphoid Leukemia,
* Other Hematological malignancy at high-risk of relapse or detectable disease and where a HSCT is indicated.
* Age \<75 years
* ECOG ≤ 2
* Acceptable lung, liver, kidney, and heart function and absence of relevant psichiatric diseases
* Signature of the informed consent

Exclusion Criteria

* Age \>75 years
* ECOG \> 2
* Not acceptable lung, liver, kidney, and heart function and presence of relevant psichiatric diseases
* Pregnancy
* No signature of the informed consent

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No