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Leukemia, Myeloid clinical trials

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NCT ID: NCT04240002 Recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Start date: September 4, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the phase 1 portion (dose escalation) of the study will be to establish an optimally safe and biologically active recommended phase 2 dose (RP2D) and/or to determine maximum tolerated dose (MTD) for gilteritinib in sequential combination with fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG). The purpose of the phase 2 portion (dose expansion) is to determine complete remission (CR) rates and composite complete remission (CRc) rates after two cycles of therapy. The study will also assess safety, tolerability and toxicities of gilteritinib in combination with FLAG, evaluate FLT3 inhibition, assess pharmacokinetics (PK), perform serial measurements of minimal residual disease, obtain preliminary estimates of 1-year event free survival (EFS) and overall survival (OS) rate and assess the acceptability as well as palatability of the formulation. One cycle is defined as 28 days of treatment. A participant completing 1 or 2 treatment cycles in phase 1 or 2 will have the option to participate in long term treatment (LTT) with gilteritinib (for up to 2 years).

NCT ID: NCT04233346 Active, not recruiting - Clinical trials for Acute Lymphoblastic Leukemia

The Study for CML Who Failed Prior TKIs or With T315I Mutation or Ph+ ALL Who Failed Prior TKIs or With T315I Mutation

Start date: July 9, 2020
Phase: Phase 2
Study type: Interventional

This protocol will allow ponatinib with refractory Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia

NCT ID: NCT04231851 Recruiting - Clinical trials for Acute Myeloid Leukemia With Myelodysplasia-Related Changes

CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia

Start date: February 19, 2020
Phase: Phase 2
Study type: Interventional

This is a phase 2 single-arm, open-label clinical trial determining efficacy of CPX-351 in combination with Glasdegib in subjects with Acute Myelogenous Leukemia with myelodysplastic syndrome related changes or therapy-related acute myeloid leukemia.

NCT ID: NCT04230564 Withdrawn - Clinical trials for Leukemia, Myeloid, Acute

Acute Myeloid Leukemia Real World Treatment Patterns

Start date: October 31, 2020
Phase:
Study type: Observational

Among patients with a diagnosis of AML who received non-intensive chemotherapy: - Describe patient demographic and clinical characteristics - Describe treatment patterns - Describe effectiveness outcomes - Evaluate tumor response

NCT ID: NCT04229979 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2

REGAL
Start date: February 8, 2021
Phase: Phase 3
Study type: Interventional

To assess the safety and efficacy of galinpepimut-S (GPS) compared with investigator's choice of best available therapy (BAT) on overall survival (OS) in subjects with acute myeloid leukemia (AML) who are in second or later complete remission (CR2) or second or later complete remission with incomplete platelet recovery (CRp2).

NCT ID: NCT04221971 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

NK Cell Infusion for Patients With Acute Myeloid Leukemia

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

Natural killer (NK) cells exert antitumor effects via their cytotoxic and cytokine-secreting capacity without present of clinical symptoms. In recent years, with the continuous advancement of in vitro expansion methods, the application of good quality management technology, NK cells could be clinical grade expanded without the need for pre-purification, feeder-free, and serum-free culture. In this clinical trial the investigators want to demonstrate the safety and efficacy chemotherapy combined with donor-derived in vitro activated NK cells infusion for high risk AML patients.

NCT ID: NCT04220684 Recruiting - Clinical trials for Refractory Acute Myeloid Leukemia

Trial Testing Safety of IL-21 NK Cells for Induction of R/R AML

Start date: June 1, 2020
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects of donor natural killer (NK) cell therapy in treating patients with acute myeloid leukemia that has come back (recurrent) or has not responded to treatment (refractory). Natural killer cells are a type of immune cell. Immunotherapy with genetically modified NK cells from donors may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread.

NCT ID: NCT04219163 Recruiting - Clinical trials for Acute Myeloid Leukemia

Chimeric Antigen Receptor T-cells for The Treatment of AML Expressing CLL-1 Antigen

Start date: July 9, 2020
Phase: Phase 1
Study type: Interventional

Patients eligible for this study have a type of blood cancer Acute Myeloid Leukemia (AML) which has come back or has not gone away after treatment. The body has different ways of fighting disease and infection, and this research study combines two different ways of fighting cancer with antibodies and T cells with the hope that they will work together. T cells (also called T lymphocytes) are special infection-fighting blood cells that can kill other cells including tumor cells. Antibodies are types of proteins that protect the body from bacterial and other infectious diseases. Both antibodies and T cells have been used to treat patients with cancers; they have shown promise, but have not been strong enough to cure most patients when used alone. T lymphocytes can kill tumor cells but there normally are not enough of them to kill all the tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person. The antibody used in this study targets CLL-1. This antibody sticks to AML cells because of a substance (protein) on the outside of these cells called CLL-1. For this study, the antibody to CLL-1 has been changed so that instead of floating free in the blood, it is now joined to the T cells. When T-cells contain an antibody that is joined to them, they are called chimeric antigen receptor T-cells or CAR-T cells. In the laboratory, the investigators have also found that T cells work better if proteins that stimulate T cells are also added, such as one called CD28. Adding the CD28 makes the cells grow better and last longer in the body, thus giving the cells a better chance of killing the leukemia or lymphoma cells. In this study we are going to attach the CLL-1 chimeric receptor that has CD28 added to it to the patient's T cells. We will then test how long the cells last. These CLL-1 chimeric antigen receptor T cells with CD28 are investigational products not approved by the Food and Drug Administration.

NCT ID: NCT04217278 Active, not recruiting - Clinical trials for Acute Myeloid Leukaemia

A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT

COSI
Start date: January 27, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Treatment options for older adults with Acute Myeloid Leukaemia (AML) and Myelodysplasia (MDS) are limited. Although stem cell transplantation remains one of the most effective treatments it is associated with severe side effects which have until recently prevented its use in older adults. In the last decade the use of reduced intensity transplants has allowed the extension of the potentially curative effect of transplantation to older patients in whom it was previously precluded. Although a major advance such transplants are associated with a high risk of disease relapse particularly in patients with high risk disease. This study will evaluate new transplant strategies with the aim of improving the outcome of patients with AML and high risk MDS after stem cell transplantation. Three approaches to improve transplant outcome will be studied: 1. Comparing the new pre-transplant consolidation therapy vyxeos with the standard consolidation therapy (Randomisation 1 is now closed to recruitment). 2. Comparing new conditioning therapies in patients under the age of 55 years 3. Comparing new conditioning therapies in patients aged 55 and over All patients will be followed up for a minimum of 2 years.

NCT ID: NCT04216563 Active, not recruiting - Clinical trials for Philadelphia Chromosome Negative, BCR-ABL1 Positive Chronic Myelogenous Leukemia

ABL001 for the Treatment of Chronic Myeloid Leukemia in Patients Who Are on Therapy With Tyrosine Kinase Inhibitor

Start date: July 29, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well ABL001 works in treating patients with chronic myeloid leukemia who are on therapy with tyrosine kinase inhibitor. ABL001 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ABL001 and tyrosine kinase inhibitor together may work better than tyrosine kinase inhibitor alone in treating patients with chronic myeloid leukemia.