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Leukemia, Myeloid, Acute clinical trials

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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.

NCT ID: NCT04266795 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy

PEVENAZA
Start date: October 13, 2020
Phase: Phase 2
Study type: Interventional

The main aim is to see how the combination of pevonedistat + venetoclax + azacitidine compares to venetoclax + azacitidine in adults recently diagnosed with AML who are unable to be treated with intensive chemotherapy. Participants will receive either pevonedistat + venetoclax + azacitidine or venetoclax + azacitidine in 28-day treatment cycles. Bone marrow samples (biopsy) will be collected throughout the study. Pevonedistat will be given as an intravenous (IV) infusion and Azacitidine will be given through IV or subcutaneous (under the skin). Study treatments may continue as long as the participant is receiving benefit from it. Participants may choose to stop treatment at any time.

NCT ID: NCT04265963 Recruiting - Leukemia Clinical Trials

CD123-Targeted CAR-T Cell Therapy for Relapsed/Refractory Acute Myeloid Leukemia

Start date: September 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

There are limited options for treatment of relapse/refractory acute myeloid leukemia (AML). CD123 CAR-T cells may have an attractive and permanent effect on anti-tumor. This study purpose to estimate the safety and efficiency of CD123 CAR-T cells to patients with relapse/refractory AML.

NCT ID: NCT04259372 Completed - Clinical trials for Acute Myeloid Leukemia

Analysis of T Cell Metabolism in Acute Myeloid Leukemia Patients

Start date: January 1, 2016
Phase:
Study type: Observational

The objective of this study was to analyze the T cell metabolism and immune phenotype in AML patients during the course of the disease before and after allo-HCT.

NCT ID: NCT04257175 Recruiting - Clinical trials for Acute Myeloid Leukemia

CAR-T CD19 for Acute Myelogenous Leukemia With t 8:21 and CD19 Expression

Start date: February 18, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Chimeric antigen receptor (CAR-T) engineered T cells against the CD19 protein have been shown to be effective against acute lymphoma and lymphocytic leukemia and are approved by the US (FDA), European (EMA) and Health Basel. However, little information exists on using CD19CAR for treatment of recurrent or irresponsible to previous treatment acute myeloid leukemia. The proposed study will include patients with recurrent disease or those with disease irresponsible to common treatments and they will be treated with CAR-T CD19.

NCT ID: NCT04256317 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML

Start date: May 21, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a randomized open-label crossover study comparing the final oral ASTX030 dose to SC azacitidine. The duration of the study is expected to be approximately 48 months.

NCT ID: NCT04254640 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

Efficacy and Safety of Cladribine in Combination With CAG in Newly Diagnosed Unfit Patients With AML

Start date: March 1, 2021
Phase: Phase 2
Study type: Interventional

In this study, the investigators conducted a phase II trial that evaluated the efficacy and safety of cladribine in combination with modified CAG regimen (low-dose cytarabine and aclarubicin) in elderly patients with AML.

NCT ID: NCT04253314 Completed - Clinical trials for Acute Myeloid Leukemia (AML)

A Study of the Effectiveness of Venetoclax Tablets in Adult Acute Myeloid Leukemia Participants Ineligible for Standard Induction Therapy in Russian Federation

INNOVATE
Start date: March 13, 2020
Phase:
Study type: Observational

Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well Venetoclax works to treat AML in adult participants who are ineligible for standard induction therapy in Russian Federation. Venetoclax is a drug approved to treat Acute Myeloid Leukemia. All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a diagnosis of AML who are ineligible for standard induction therapy will be enrolled. Around 50 participants will be enrolled in the study in approximately 15 sites in Russian Federation. Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 18 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice (approximately every 3 months) and participants will be followed for 18 months.

NCT ID: NCT04250051 Recruiting - Clinical trials for Refractory Acute Myeloid Leukemia

Ivosidenib and Combination Chemotherapy for the Treatment of IDH1 Mutant Relapsed or Refractory Acute Myeloid Leukemia

Start date: December 21, 2020
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of ivosidenib when given together with combination chemotherapy for the treatment of 1DH1 mutant acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). Ivosidenib may stop the growth of cancer cells by blocking the IDH1 mutation and some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate, cytarabine, and filgrastim, 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 ivosidenib with combination chemotherapy may work better in treating patients with acute myeloid leukemia compared to chemotherapy alone.

NCT ID: NCT04248595 Recruiting - Clinical trials for Acute Myeloid Leukemia

Study of Azacitidine Combined With Homoharringtonie Based Regimens in AML

Start date: December 1, 2019
Phase: Phase 2
Study type: Interventional

Rencent years have witnessed great progress of the treatment of acute myeloid leukemia (AML). However, most patients have poor outcomes following the currently first-line DA(daunorubicin, cytarabine)/IA(Idarubicin, cytarabine) chemotherapy, espiecially for the older patients and those not eligiable for receiving allo-HSCT. Azacitidine (AZA),a hypomethylating agent, targets epigenetic gene silencing by inhibiting gene expression against malignant phenotypes and is currently approved to treat AML based on the NCCN guidelines. The homoharringtonie (HHT) could induce AML cell lines and primary myeloid leukemia cell apoptosis, and the effect was dose dependent. While, HHT could also induce leukemia cells to differentiate into normal state, eventually achieve the goal of treatment, and control the disease. The investigators conducted a clinical study to evaluate the efficacy and safety of the AZA plus HAG(homoharringtonie, cytarabine, G-CSF), HIA(homoharringtonie, Idarubicin, cytarabine)/HDA(homoharringtonie, daunorubicin, cytarabine). This study is aimed to demonstrate the efficacy and safety advantages of the regimens that cotain homoharringtonie and azacitidine.