Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Haplo stem cell transplant (from bone marrow or apheresis) is followed by a haplo-NK cell infusion (target dose ≥1\*106/kg b.w.) at day 7.

Unstimulated haplo-NK cells are collected through apheresis Mononuclear cells are then subjected to a preliminary negative selection of CD3+ cells and to a subsequent positive selection of CD56+ cells. CD3 negative/CD56 positive cells are infused

Patients in this arm receive standard haplo stem cell transplant (from bone marrow or apheresis) transplant without subsequent NK cell infusion.

Patients in this arm receive haplo-SCT followed by one boost of NK cells one/two weeks after the transplant. Lymphocyte are collected by apheresis from the donor one-two weeks after BM harvest. CD3 negative/CD56 positive cells are selected by immunomagnetic columns (other lymphocytes are stored to be used as DLI)

Haplo SCT with NK cells

Patients in this arm receive a standard haplo-SCT. All administerd therapies are the same as in other arm, except for the NK cell boost..

Haplo SCT

Andrea Bacigalupo, Prof

Relapse after an allogeneic hematopoietic stem cell transplantation (HSCT) is high in patients with advanced AML, in the 50% range. NK cells have been shown to possess significant anti-leukemic activity and may be used to reduce the incidence of relapse in patients with advanced AML.

Investigators hypothesize that the administration of a purified boost of NK cells on day +7 post HSCT, will reduce the incidence of relapse from the current 50% to 25%. In a phase III multicenter clinical study, 116 patients will be randomized to receive or not a boost of donor NK cells on day +7 post-HSCT. The first 10 patients in the experimental arm will be analyzed for toxicity. The stopping rule will be a transplant related mortality of more than 50% in the first 20 patients who received NK cells.

Haploidentical Stem Cell Transplant With or Without NK Cell Infusion in AML and MDS

Haploidentical Stem Cell Transplantation With or Without NK Cell Infusion in Refractory/Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndrome:The BigEMINy Study

Cumulative incidence of leukemia relapse.

Ministry of Health, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Haploidentical Stem Cell Transplant With or Without NK Cell Infusion in AML and MDS	NCT04166929	Acute Myeloid L... Myelodysplasia	Haplo SCT with ... Haplo SCT	18 Years - 75 Years	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Haploidentical Stem Cell Transplant With or Without NK Cell Infusion in AML and MDS	NCT04166929	Acute Myeloid L... Myelodysplasia	Haplo SCT with ... Haplo SCT	18 Years - 75 Years	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Haploidentical Stem Cell Transplant With or Without NK Cell Infusion in AML and MDS	NCT04166929	Acute Myeloid L... Myelodysplasia	Haplo SCT with ... Haplo SCT	18 Years - 75 Years	Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Spots Global Cancer Trial Database for haplo sct

Every month we try and update this database with for haplo sct cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for haplo sct

Every month we try and update this database with for haplo sct cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for haplo sct cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.