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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Ellice
Marwood
-
EMarwood@ITS.JNJ.com
Dr
Sponsor
Contact
+44 (0)800 731 8450; (0)1494 567444
medinfo@its.jnj.com
Dr
Emma
Searle
+44 (0)161 446 3093
helen.kay3@nhs.net
Acute myeloid leukemia
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Leukaemia (cancer of the white blood cells) is diagnosed as acute when it progresses quickly and aggressively and usually requires immediate treatment. Acute myeloid leukaemia (AML) affects the myeloid cells that fight bacterial infections and other conditions. KMT2A or NPM1 gene alterations can be associated with AML. Treatment options for AML are limited, survival rates are poor, and many patients are ineligible for standard chemotherapy treatments due to toxicity. The study purpose is to determine the recommended phase II study dose(s) of bleximenib in combination with AML-directed therapies and further to evaluate the safety and tolerability of bleximenib in combination with AML-directed therapies at these dose(s).
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Acute promyelocytic leukemia according to WHO 2016 criteria 2. Leukemic involvement of the central nervous system 3. Recipient of solid organ transplant 4. Cardiovascular disease that is uncontrolled, increases the risk for Torsades de Pointes or that was diagnosed within 6 months prior to the first dose of study treatment including, but not limited to:4.1. Myocardial infarction4.2. Severe or unstable angina4.3. Clinically significant cardiac arrhythmias, including bradycardia (less than [<] 50 beats per minute)4.4. Uncontrolled (persistent) hypertension: (example, blood pressure greater than [>] 140/90 millimeters of mercury [mm Hg]4.5. Acute neurologic events such as stroke or transient ischemic attack, intracranial or subarachnoid hemorrhage, intracranial trauma4.6. Venous thromboembolic events (for example, pulmonary embolism) within 1 month prior to the first dose of study treatment (uncomplicated Grade less than or equal to [≤]2 deep vein thrombosis is not considered exclusionary)4.7. Congestive heart failure (NYHA class III to IV); (h) Pericarditis or clinically significant pericardial effusion4.8. Myocarditis4.9. Endocarditis 4.10. Clinically significant hypokalemia, hypomagnesemia, hypocalcemia (corrected for hypoalbuminemia) 5. Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from previous anticancer therapy that has not resolved to baseline or to grade 1 or less 6. Pulmonary compromise that requires the need for supplemental oxygen use to maintain adequate oxygenation
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Ellice
Marwood
-
EMarwood@ITS.JNJ.com
Dr
Sponsor
Contact
+44 (0)800 731 8450; (0)1494 567444
medinfo@its.jnj.com
Dr
Emma
Searle
+44 (0)161 446 3093
helen.kay3@nhs.net
The study is sponsored by Janssen Pharmaceutica NV and funded by Janssen Research and Development.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 52246
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
