Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Midostaurin

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Protein Kinase Inhibitors

Enzyme Inhibitors

Treatment will consist of 3 phases: induction (a 28-42 day cycle), followed by consolidation (up to 4 cycles). Each cycle in the consolidation phase will last 28 days. Subjects will proceed from one phase to the next if they have achieved or maintained a complete remission or complete remission with incomplete blood count recovery by International Working Group 2003 response criteria. Patients may receive a allogeneic hematopoietic stem cell transplant between the end of the induction phase.

Induction Phase: 50 mg orally twice daily beginning on day 7 and ending 48 hours prior to beginning the consolidation phase

Consolidation Phase: 50 mg orally twice daily beginning on Day 6 and ending 48 hours prior to either the start of the next cycle or beginning conditioning therapy for allogenic stem cell transplant.

Induction Phase: 3 g/m2 (patients 18-65 years old) or 1 g/m2 (patients \> 65 years old or those with co-morbidities precluding a higher dose) by vein over 3 hours every 12 hours on Days 1-6.

Consolidation Phase: 3 g/m2 (patients 18-65 years old) or 1 g/m2 (patients \> 65 years old or those with co-morbidities precluding a higher dose) by vein over 3 hours every 12 hours on Days 1, 3, and 5 of each cycle.

Maxim Norkin, MD, PhD

This is an open label, single arm study of midostaurin in patients with relapsed or refractory AML.

Clinical trials have shown that the multi-kinase inhibitor midostaurin improves survival in patients with AML. The main objective of this study is to investigate its effect (in conjunction with cytarabine) on progression free survival, as well as overall survival and morphologic response rate in patients with relapsed or refractory AML. This study will also attempt to identify specific populations of patients with relapsed or refractory AML who best respond to treatment with midostaurin to enhance treatment planning.

All patients will receive midostaurin and cytarabine.

iCare4: Genomic Signatures With Midostaurin in Acute Myeloid Leukemia (UF-HEM-004)

A Phase II, Open-Label Clinical Efficacy Study Defining Genomic Signatures That Correlate With Midostaurin Response in Relapsed or Refractory Acute Myeloid Leukemia (AML)

Compare the progression free survival of patients receiving midostaurin and cytarabine to that historically achieved in patients receiving cytarabine alone

Assess the incidence and severity of toxicities of midostaurin and cytarabine using CTCAE v4.0

Compare the overall survival of patients receiving midostaurin and cytarabine to that historically achieved in patients receiving cytarabine alone

Compare the morphologic response rate (using International Working Group 2003 criteria) of patients receiving midostaurin and cytarabine to that historically achieved in patients receiving cytarabine alone

Novartis Pharmaceuticals

University of Florida

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Laura Hughes

Will Dr Ricketts

Chuen Ryan Dr Khaw

Sam Prof Janes

Sam Janes

Prospective, observational cohort study of patients undergoing surgical resection for low dose CT (LDCT) screen-detected lung cancer (detected through the SUMMIT study- ClinicalTrials.gov Identifier: NCT03934866/ lung screening programmes), in which translational research is a fundamental aspect.

The ASCENT study seeks to examine the genomic signatures of screen-detected cancers, in order to categorise the biological behaviour of such lesions and correlate this against non-invasive biological and radiological parameters. From these data, the plan is to explore strategies to characterise LDCT-detected cancers through non-invasive means, which the researchers believe may prove key in mitigating potential screening-associated harms.

Blood collection will take place from consented patients at the time of anaesthetic induction pre-surgery, to include:

* 4 x 10ml EDTA-Streck tubes for germline DNA/RNA and exploratory biomarker analyses
* Tumour surplus to diagnostic and pathological requirements will be collected for whole exome sequencing and RNA profiling.
* Archival Diagnostic FFPE blocks and slides.

Analysis of Screen-detected Lung Cancers' Genomic Traits

Measuring the differences in chromosomal instability between fast- and slow-growing screen detected cancers, quantified by weighted genome integrity index (WGII) derived from whole exome sequencing (WES) data

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
iCare4: Genomic Signatures With Midostaurin in Acute Myeloid Leukemia (UF-HEM-004)	NCT03207334	Acute Myeloid L...	Midostaurin Cytarabine	18 Years - 75 Years	University of Florida
Analysis of Screen-detected Lung Cancers' Genomic Traits	NCT04204499	Lung Cancer		50 Years - 77 Years	University College, London
Analysis of Screen-detected Lung Cancers' Genomic Traits	NCT04204499	Lung Cancer		50 Years - 77 Years	University College, London

Spots Global Cancer Trial Database for genomic signatures