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Leukemia, Myeloid, Acute clinical trials

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NCT ID: NCT03915379 Completed - Clinical trials for Myelodysplastic Syndromes

A Study of JNJ-67571244 in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Start date: March 28, 2019
Phase: Phase 1
Study type: Interventional

The main purpose of this study are to determine the recommended Phase 2 dose(s) (RP2D) route of administration, schedule and the maximum tolerated dose (MTD) in Part 1 and to determine the safety and tolerability of JNJ-67571244 at the RP2D regimen(s) and to evaluate the preliminary clinical activity of JNJ-67571244 in Part 2.

NCT ID: NCT03894852 Completed - Clinical trials for Therapy Related Myelodysplastic Syndrome and Therapy Related Acute Myeloid Leukemia

SRSF2 Gene Mutation in Patients With t-MDS/AML

Start date: June 2, 2019
Phase:
Study type: Observational

- To detect SRSF2 gene mutation by polymerase chain reaction (PCR) in the two types of t-MDS/AML which recognized in the WHO classification. - Association between SRSF2 gene mutation and the presence of other cytogenetic abnormalities in the two types of t-MDS/AML which recognized in the WHO classification, e.g. (Loss of chromosome 7 or del(7q), del(5q), isochromosome 17q, recurrent balanced chromosomal translocations involving chromosomal segments 11q23 (KMT2A, previously called MLL) or 21q22.1 (RUNX1), and PML-RARA). - Relationship between SRSF2 gene mutation and cumulative dose, dose intensity, time of exposure and prognostic criteria (disease free survival, overall survival and disease course).

NCT ID: NCT03881826 Completed - Clinical trials for Acute Myeloid Leukemia

Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia

MicroAML
Start date: December 4, 2015
Phase: N/A
Study type: Interventional

This cohort study aims to investigate the composition and activity of the gut microbiota of patients newly diagnosed for acute myeloid leukemia (AML), in relationship with their food habits and cachectic hallmarks. The recruitment for this study is currently ongoing with the help of clinicians, nurses and data managers at the Saint-Luc clinics, University Hospital Leuven (Campus Gasthuisberg) and University Hospital Gent. Primary Objective •To assess the composition and activity of the gut microbiota in patients with acute myeloid leukemia (AML) compared to matched control subjects. Secondary Objectives - To investigate correlations between the gut microbiota, cachectic hallmarks and gut microbiota-related markers in the blood (gut permeability markers, microbial compounds, microbial metabolites). - To characterize the changes in the gut microbial ecosystem that are induced by chemotherapy and associated with colitis. - To assess whether the composition of the gut microbiota can predict the severity of chemotherapy-related colitis. Study Design This is an academic multi-centric prospective study. The study is composed of two cohorts (Fig. 1). In Cohort A, patients are included before any chemotherapy. Biological samples (urine, feces, blood) are collected, alongside information on nutritional habits, appetite and medical records. Muscle strength and body composition are also measured. Only patients receiving a standard chemotherapy are included in Cohort B. In Cohort B, biological samples are collected and body composition, muscle strength and appetite are evaluated at 2 different time points, at the end of the chemotherapy (T1) and at discharge (T4).

NCT ID: NCT03848754 Completed - Relapsed Adult AML Clinical Trials

Pracinostat and Gemtuzumab Ozogamicin (PraGO) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Start date: May 24, 2019
Phase: Phase 1
Study type: Interventional

This is a prospective, single-center phase 1 clinical study aimed at determining the maximum-tolerated dose and safety of the combination of gemtuzumab ozogamicin (GO) and pracinostat (P) in patients with relapsed/refractory acute myeloid leukemia.

NCT ID: NCT03823352 Completed - Clinical trials for Leukemia, Myeloid, Acute

Evaluate Efficacy and Safety/Tolerability Profiles of Antroquinonol in Acute Myeloid Leukemia (AML) Adult Patients

Start date: February 20, 2019
Phase: Phase 2
Study type: Interventional

This is a IIa phase IIa open-label, non-randomized clinical trial of Antroquinonol, capsule, 100 mg (Golden Biotechnology Corporation, Taiwan) in patients with AML.

NCT ID: NCT03820908 Completed - Clinical trials for Acute Myelogenous Leukemia

Bisantrene for Relapsed /Refractory AML

Start date: July 18, 2019
Phase: Phase 2
Study type: Interventional

Induction of response in patients with AML that are either primary resistant (failed induction and or salvage therapy) or relapsed including post allogeneic stem cell transplantation and failed salvage therapy or cannot receive additional anthracycline .

NCT ID: NCT03814005 Completed - Neoplasms Clinical Trials

A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems

Start date: July 10, 2019
Phase: Phase 1
Study type: Interventional

Pevonedistat is a medicine to treat people with blood cancers or solid tumors. The main aim of the study is to learn about the levels of pevonedistat in the blood of participants with blood cancers or solid tumors, who also have severe kidney problems or mild to moderate liver problems. The information from this study will be used to work out the best dose of pevonedistat to give people with these conditions in future studies. At the first visit, the study doctor will check who can take part in the study. This study is in 2 parts: A and B. Part A Participants will be placed into 1 of 4 treatment groups depending on how severe their kidney and liver problems are. All participants will receive 1 dose of pevonedistat as a slow injection in their vein (infusion). Then, the study doctors will check the levels of pevonedistat in the blood of the participants for 3 days after the infusion. They will also check if the participants have any side effects from pevonedistat. Participants will be asked to continue to Part B. Those who don't want to continue will visit the clinic 30 days later for a final check-up. Part B Participants who agree to participate into Part B will receive an infusion of pevonedistat on specific days during a 21-day or 28-day cycle. The cycle time will depend on what type of cancer the participants have. Participants will also be treated with standard of care medicines for their kidney and liver problems during this time. In the first cycle, the study doctors will also check the levels of pevonedistat in the blood and urine of participants for 3 days after the infusion. Participants will continue with cycles of treatment together with standard of care medicines until their condition gets worse or they have too many side effects from the treatment. When treatment has finished, participants will visit the clinic 10 days later for a final check-up.

NCT ID: NCT03813186 Completed - Clinical trials for Acute Myeloid Leukemia

Effect of Food on Blood Levels of ASTX727

Start date: November 8, 2018
Phase: Phase 1
Study type: Interventional

This study is designed to examine blood levels of ASTX727, a fixed-dose combination tablet containing the combination of cedazuridine (100 mg) and decitabine (35 mg), when given under fed versus fasted conditions to participants with myelodysplastic syndromes (MDS), including refractory anemia with excess blasts in transformation or chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML). This study will also assess the safety of ASTX727.

NCT ID: NCT03813147 Completed - Clinical trials for Refractory Acute Myeloid Leukemia

Pevonedistat, Azacitidine, Fludarabine Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Start date: May 17, 2019
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and how well pevonedistat, azacitidine, fludarabine phosphate, and cytarabine work in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has come back (relapsed) or has not responded to treatment (refractory). Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as azacitidine, fludarabine phosphate, and cytarabine, 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. Giving more than one drug (combination chemotherapy) and pevonedistat may work better in treating patients with acute myeloid leukemia or myelodysplastic syndrome.

NCT ID: NCT03790072 Completed - Clinical trials for Acute Myeloid Leukemia

Ex-vivo Expanded γδ T-lymphocytes (OmnImmune®) in Patients With Acute Myeloid Leukaemia (AML)

Start date: November 27, 2018
Phase: Phase 1
Study type: Interventional

This study investigates the potential curative properties of gamma delta T-cells obtained from a blood-related donor of an AML patient.