First-in-Human Dose Escalation Study of AFM28 in Patients With Relapsed/Refractory Acute Myeloid...
Acute Myeloid LeukemiaThis study is a First In Human, phase 1, open-label, non-randomized, multi-center, multiple ascending dose escalation study evaluating AFM28 as a monotherapy in subjects with Relapsed/Refractory CD123-positive Acute Myeloid Leukemia (AML). AFM28 is a tetravalent monoclonal antibody targeting the interleukin-3 receptor subunit alpha (IL3RA, CD123) and the low affinity immunoglobulin gamma Fc region receptor III-A (FCGR3A, CD16A). It is developed as an antineoplastic agent for hematologic malignancies known to express CD123. The primary pharmacological Mode of Action of AFM28 is induction of cell death of CD123-expressing cells by stimulating Antibody-Dependent Cell-mediated Cytotoxicity mediated by CD16A-expressing immune cells, primarily Natural Killer cells. The aim of the dose escalation is to determine the Maximum Tolerated Dose (MTD) and/or establish one or more Recommended Phase 2 Doses, based on safety, preliminary anti-leukemic activity and Pharmacokinetics / Pharmacodynamics data.
A Pilot Study to Evaluate the Feasibility of Post-Hematopoietic Stem Cell Transplant Prophylaxis...
Acute Myeloid LeukemiaMyelodysplastic Syndromes5 moreThe purpose of this study is to examine if it is feasible to administer decitabine and filgrastim after allogenic hematopoietic stem cell transplant (HCT) in children and young adults with myelodysplastic syndrome, acute myeloid leukemia and related myeloid disorders, and if the treatment is effective in preventing relapse after HCT. The names of the study drugs involved in this study are: Decitabine (a nucleoside metabolic inhibitor) Filgrastim (a recombinant granulocyte colony-stimulating factor (G-CSF)
A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine,...
Acute Myeloid LeukemiaMixed Lineage Acute Leukemia10 moreThis Phase 1 study will assess the safety, tolerability, and preliminary antileukemic activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3 for two different molecularly-defined arms, NPM1-m and KMT2A-r.
Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results
AMLMRDThis is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia based on MRD results on day 14 of the first cycle.
Venetoclax in Combination With 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard...
Acute Myeloid Leukemia (AML)Acute myeloid leukemia (AML): continuous oral Venetoclax (VEN) and 7 days of s.c. Azacitidine (AZA) per 28-day cycle = standard of care for intensive induction therapy ineligible AML patients in Germany The VENAZA-5S pilot trial: AZA administration reduced to 5 days within each cycle to improve tolerability and treatment adherence due to less neutropenic infections, less treatment interruptions and less hospitalizations.
A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute...
Acute Myeloid LeukemiaThis is a phase 2 study to test the hypothesis that venetoclax in combination with standard chemotherapy will be tolerable and active in pediatric patients with newly diagnosed acute myeloid leukemia (AML). Primary Objectives: Establish the tolerability adding venetoclax to standard chemotherapy in pediatric patients with AML Estimate the proportion of patients who become minimal residual disease (MRD) negative by flow cytometry after one course of venetoclax-based induction therapy Secondary Objectives: - Estimate the rates of complete remission (CR), event-free survival (EFS), and overall survival (OS) in pediatric patients who receive venetoclax-based chemotherapy
Optimized Dual CD33/CLL1 CAR T Cells in Subjects With Refractory or Relapsed Acute Myeloid Leukemia...
Acute Myeloid LeukemiaThis is a single-center, open-label, non-randomized, single-arm Phase 1 Study to evaluate safety and tolerability of optimized Dual CD33/CLL1 CAR T Cells in subjects with refractory or relapsed acute myeloid leukemia. Maximum of twenty subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion chemotherapy (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day) will be administrated for 3 days. Then this study will be using BOIN1/2 approach from starting dose 1: 1×10^6 (±20%) to dose 2: 5×10^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10^5 (±20%) /kg.
Navitoclax, Venetoclax, and Decitabine for the Treatment of Relapsed or Refractory Acute Myeloid...
Recurrent Acute Myeloid LeukemiaRefractory Acute Myeloid LeukemiaThis phase Ib trial is to find the side effect and best dose of navitoclax when given together with venetoclax and decitabine in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory) after previous treatment with venetoclax. Chemotherapy drugs, such as navitoclax, venetoclax, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
A Study of HYML-122 and Cytarabine in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid...
Relapsed or Refractory Acute Myeloid Leukemia (AML)This is a single-arm, open, multicenter, phase 2 study to evaluate the efficacy, safety and pharmacokinetics of HYLM-122 in combination with cytarabine in Chinese subjects with FLT3 positive relapsed or refractory acute myeloid leukemia.
AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Acute Myeloid Leukemia RefractoryAcute Myeloid Leukemia2 moreThe primary objective is to define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for dose expansion study.