
A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus...
Acute Myeloid LeukemiaThe purpose of this study is to assess the efficacy and safety of oral azacitidine plus best supportive care versus best supportive care as maintenance therapy in a cohort of Japanese participants ≥ 55 years of age with Acute Myeloid Leukemia (AML) and in complete remission/complete remission with incomplete blood count recovery after conventional induction chemotherapy with or without consolidation chemotherapy.

Study of Anti-CD33/CLL1 CAR-NK in Acute Myeloid Leukemia
Acute Myeloid LeukemiaThis is an open-label, nonrandomized, investigator-initiated clinical trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of anti-CD33/CLL1 CAR-NK cell injection in patients with acute myeloid leukemia (AML), and to determine PK parameters, maximum tolerated dose (MTD), and phase II recommended dose (RP2D) for subjects receiving CAR-NK cell injection.

90Y-DOTA-anti-CD25 Basiliximab, Fludarabine, Melphalan, and Total Marrow and Lymphoid Irradiation...
Acute Lymphoblastic LeukemiaAcute Myeloid Leukemia2 moreThis phase I trial is to find out the best dose, possible benefits and/or side effects of 90Y-DOTA-anti-CD25 basiliximab given together with fludarabine, melphalan, and total marrow and lymphoid irradiation (TMLI) in treating patients with high-risk acute leukemia or myelodysplastic syndrome. 90Y-DOTA-anti-CD25 basiliximab is a monoclonal antibody, called basiliximab, linked to a radioactive agent called 90Y-DOTA. Basiliximab attaches to CD25 positive cancer cells in a targeted way and delivers 90Y-DOTA to kill them. Fludarabine and melphalan are common chemotherapy drugs used to prepare the bone marrow to receive transplanted cells. TMLI is a different type of targeted radiation therapy used to prepare the bone marrow to receive transplanted cells. Giving 90Y-DOTA-anti-CD25 basiliximab together with fludarabine, melphalan, and TMLI may help prepare the bone marrow to receive the transplanted cells for improved transplant outcomes in patients with acute leukemia or myelodysplastic syndrome.

Clinical Trial to Assess the Safety and Tolerability of the Combination of Low-dose Cytarabine or...
LeukemiaMyeloid3 moreA phase I-II trial based on the combination of three drugs regimen LDAC or Azacitidine + Venetoclax + Quizartinib that in this population could be well tolerated by a sequential type administration. The first objective is to achieve rapid control of the disease, using two different schemes, one based in Azacitidine and the other in LDAC, by dose escalation in phase I of the trial. The second goal is to prevent relapse through a maintenance schedule. Phase II will study the efficacy and safety of the recommended dose for Phase II

IS-free Treg HaploHCT
Stem Cell Transplant ComplicationsGraft Vs Host Disease4 moreThis research study is evaluating the safety and efficacy of the IS-free Treg-cell graft-engineered haplo transplant method in people with relapsed/refractory and Ultra-high risk acute myeloid leukemia (AML) and/or myelodysplastic syndromes (MDS) receiving a haploidentical donor allogeneic hematopoietic stem cell transplant (HSCT). The names of the study interventions involved in this study are: Radiation-Total Myeloid and Lymphoid Irradiation (TMLI Chemotherapy (Fludarabine, Thiotepa, Cyclophosphamide plus Mesna) Infusion of haplo Treg-enriched donor cells (experimental therapy) Infusion of unmodified haplo donor T cells (includes cancer-fighting T effector cells) Infusion of haplo donor CD34+ Peripheral Blood Stem Cells

ACHIEVE - Efficacy and Effectiveness of Adoptive Cellular tHerapy wIth Ex-Vivo Expanded Allogeneic...
Acute Myeloid LeukemiaThis is an open label, adaptive, efficacy and effectiveness, phase II clinical trial in adult patients with AML with refractory and relapsed disease. An adaptive trial approach with a two-stage Simon design will be utilised for a total of up to 74 adult patients per dose level of TCB008 cells

A Study of Siremadlin Alone and in Combination With Donor Lymphocyte Infusion in Acute Myeloid Leukemia...
Acute Myeloid LeukemiaAllogeneic Stem Cell TransplantationThe purpose of this study is to confirm a safe dose and schedule as well as the preliminary efficacy of siremadlin alone, and in combination with donor lymphocyte infusion (DLI), in adult participants with AML who are in remission following allogeneic stem cell transplantation (allo-SCT) but are at high risk for relapse based on the presence of pre-transplant risk factors.

Enasidenib in Combination With Cobimetinib for the Treatment of Relapsed or Refractory Acute Myeloid...
Recurrent Acute Myeloid LeukemiaRefractory Acute Myeloid LeukemiaThis phase Ib trial tests the safety, side effects, and best dose of a enasidenib in combination with cobimetinib in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). Enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Cobimetinib is used in patients whose cancer has a mutated (changed) form of a gene called BRAF. It is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving enasidenib and cobimetinib may kill more cancer cells in patients with relapsed or refractory acute myeloid leukemia.

G-CSF+DAC+BUCY vs G-CSF+DAC+BF Conditioning Regimen for Secondary Acute Myeloid Leukemia Undergoing...
Secondary Acute Myeloid Leukemia Evolving From MDSAllogeneic Hematopoietic Stem Cell Transplantation1 moreAllo-HSCT is the most effective way to cure sAML patients. At present, the best conditioning regimen for sAML patients undergoing allo-HSCT remains in discussion. In this prospective study, the safety and efficacy of G-CSF+DAC+BUCY and G-CSF+DAC+BF conditioning regimens in sAML patients undergoing allo-HSCT are evaluated.

Azacitidine in Combination With Low Dose Intensity Venetoclax in Patients With AML Incl. Explorative...
Acute Myeloid LeukemiaMulti-center phase II study of standard azacytidine treatment (AZA; D1-D7, 75mg/m2 qd) in combination with a short duration of "low-dose" venetoclax treatment (LD-VEN; D1-D14 before CR and D1-D7 after CR, 400mg qd) per 28 days cycle for elderly/unfit (arm 1) and relapsed/refractory (arm 2) patients with acute myeloid leukemia. AZA and LD-VEN treatment is combined with exploratory AML profiling using established platforms for OMICs analyses and ex vivo drug sensitivity and resistance testing. This will validate the feasibility of AML profiling in a clinical setting to predict responders and non-responders to AZA/LD-VEN therapy. The exploratory AML profiling program will also identify biomarkers as well as novel drugs and drug combinations applicable for treatment of AML patients in future clinical trial initiatives.