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Leukemia, Myeloid, Acute clinical trials

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NCT ID: NCT04477291 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS

Start date: October 6, 2020
Phase: Phase 1
Study type: Interventional

This study is being done to evaluate the safety, tolerability and antitumor activity of oral CG-806 (luxeptinib) for the treatment of patients with Acute Myeloid Leukemia (except APML), secondary AML, therapy-related AML, or higher-risk MDS, whose disease has relapsed, is refractory or who are ineligible for or intolerant of intensive chemotherapy or transplantation.

NCT ID: NCT04473911 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Haplo Peripheral Blood Sct In GVHD Prevention

Start date: August 14, 2020
Phase: Phase 1
Study type: Interventional

This research study is studying the RGI-2001 for preventing Graft-vs-Host Disease (GVHD) in people with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), myeloproliferative disorders (MPN), chronic myelomonocytic leukemic (CMML), chemosensitive hodgkin lymphoma (HL), or Non-Hodgkin lymphoma (NHL).who will have a blood stem cell transplantation. - GVHD is a condition in which cells from the donor's tissue attack the organs. - RGI-2001 is an investigational treatment

NCT ID: NCT04435691 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Magrolimab, Azacitidine, and Venetoclax for the Treatment of Acute Myeloid Leukemia

Start date: July 28, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This phase Ib/II trial studies the side effects and best dose of magrolimab and venetoclax when given together with azacitidine and to see how well they work in treating patients with acute myeloid leukemia. Magrolimab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, such as azacitidine, 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. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving magrolimab, azacitidine, and venetoclax may help to control the disease.

NCT ID: NCT04380441 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Quality of Life Model for Older Patients With AML

Start date: July 8, 2020
Phase:
Study type: Observational

The purpose of this study is to describe the differences in quality of life (QOL) among newly diagnosed patients diagnosed with acute myeloid leukemia (AML) to help design a patient decision-making QOL model for aligning patients' choice of treatment with what matters the most to them.

NCT ID: NCT04318678 Active, not recruiting - B-ALL Clinical Trials

CD123-Directed Autologous T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML)

Start date: July 29, 2020
Phase: Phase 1
Study type: Interventional

The CD123-CAR T-cell therapy is a new treatment that is being investigated for treatment of AML/myelodysplastic syndrome (MDS), T- or B- acute lymphoblastic leukemia (ALL) or blastic plasmacytoid dendritic cell neoplasia (BPDCN). The purpose of this study is to find the maximum (highest) dose of CD123-CAR T cells that is safe to give to these patients. This would include studying the side effects of the chemotherapy, as well as the CD123-CAR T-cell product on the recipient's body, disease and overall survival. Primary Objective To determine the safety of one intravenous infusion of escalating doses of autologous, CD123-CAR T cells in patients (≤21 years) with recurrent/refractory CD123+ disease (AML/MDS, B-ALL, T-ALL or BPDCN) after lymphodepleting chemotherapy. Secondary Objectives To evaluate the antileukemia activity of CD123-CAR T cells. Exploratory Objectives - To assess the immunophenotype, clonal structure and endogenous repertoire of CD123-CAR T cells and unmodified T cells - To characterize the cytokine profile in the peripheral blood and CSF after treatment with CD123-CAR T cells - To characterize tumor cells post CD123-CAR T-cell therapy

NCT ID: NCT04284787 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit Patients With Acute Myeloid Leukemia

Start date: February 16, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well azacitidine and venetoclax with or without pembrolizumab work in treating older patients with newly diagnosed acute myeloid leukemia. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving azacitidine and venetoclax with pembrolizumab may increase the rate of deeper/better responses and reduce the chance of the leukemia coming back in patients with newly diagnosed acute myeloid leukemia compared to conventional therapy of azacitidine and venetoclax alone.

NCT ID: NCT04284228 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

Antigen-specific T Cell Therapy for AML or MDS Patients With Relapsed Disease After Allo-HCT

Start date: February 20, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This Research study is being done to characterize the safety, tolerability, and preliminary antitumor activity of the NEXI-001 T cell product (a new experimental therapy), which contains populations of CD8+ T cells targeting multiple leukemia associated antigen peptides in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who have relapsed disease after an allogeneic hematopoietic cell transplant (HCT). The study will enroll AML or MDS patients who have either Minimal Residual Disease (MRD) or relapsed disease after a human leukocyte antigen (HLA)-matched allogeneic HCT. Patients who have had an HLA-mismatched or haploidentical allogeneic HCT will not be eligible to participate in this study. Eligible patients for this study must also have ≥ 50% T-cell chimerism from the original donor at the time study entry. The enrolled patients will undergo bridging therapy for the purposes of disease control while the NEXI-001 T cell product is being manufactured. Choice of bridging therapy administered will be per the Investigator's discretion, but is limited to acceptable agents as specified in the protocol. Bridging therapy will be administered prior to lymphodepleting (LD) therapy, with the last dose of the bridging therapy administered ≥ 14 days prior to initiation of LD therapy. Within 72 hours after completing LD therapy, patients will receive a single IV infusion of the NEXI-001 T cell product.

NCT ID: NCT04282668 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of TAS1440 With ATRA in Subjects With r/r AML

Start date: March 15, 2020
Phase: Phase 1
Study type: Interventional

This is a multicenter, 2-part, Phase 1 study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of TAS1440 administered as a single agent and in combination with all-trans retinoic acid (ATRA) in participants with acute myeloid leukemia (AML) who have relapsed or are refractory (r/r) to prior treatment. The study duration is expected to be approximately 30 months.

NCT ID: NCT04277442 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Testing Nivolumab in Combination With Decitabine and Venetoclax in Patients With Newly Diagnosed TP53 Gene Mutated Acute Myeloid Leukemia

Start date: March 11, 2020
Phase: Phase 1
Study type: Interventional

This trial studies the side effects of nivolumab in combination with decitabine and venetoclax and to see how well they work in treating patients with TP53-mutated acute myeloid leukemia. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as decitabine and venetoclax, 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. This study is being done to find out whether giving nivolumab, decitabine, and venetoclax is better or worse than the usual approach for TP53-mutated acute myeloid leukemia.

NCT ID: NCT04267081 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Study of Venetoclax in Combination With Azacytidine in AML Patients Selected Using Ex Vivo Drug Sensitivity Screening

VenEx
Start date: February 12, 2020
Phase: Phase 2
Study type: Interventional

This is a multi center two-stage, two-arm, open label phase II study of venetoclax in combination with azacytidine in acute myeloid leukemia patients selected for therapy with ex vivo venetoclax sensitivity screening. This study will characterize the usability of ex vivo drug sensitivity testing for patient selection for selecting the responsive patients for venetoclax therapy. The exploratory study will aim to find novel combinations for overcoming resistance as well as finding/validating biomarkers for both sensitivity and resistance.