All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know AML.
The aml Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the aml Hub cannot guarantee the accuracy of translated content. The aml and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The AML Hub is an independent medical education platform, sponsored by Astellas, Daiichi Sankyo, Johnson & Johnson, Kura Oncology and Syndax, and has been supported through educational grants from Bristol Myers Squibb and the Hippocrate Conference Institute, an association of the Servier Group. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out moreCreate an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View AML content recommended for you
On 6th March 2017, the U.S. Food and Drug Administration (FDA) lifted a clinical hold on the phase I clinical trials of experimental drug vadastuximab talirine (SGN-CD33A; a CD33-directed antibody drug conjugate) for patients with Acute Myeloid Leukemia (AML).
In January 2017, the AML Global Portal (AGP) reported on the clinical hold placed on a phase I/II trial of vadastuximab talirine by the FDA after four patients who were treated with this agent along with Allogeneic Hematopoietic Cell Transplant (AHCT), either prior to or following treatment, died. Additionally, a partial clinical hold was placed on phase I trials of vadastuximab talirine consisting of no further enrollment of new patients.
After a comprehensive analysis of clinical data from 300 AML patients who were treated with vadastuximab talirine by an independent committee of clinical experts and collaborations with the FDA, the FDA lifted the clinical hold placed on the phase I trials with vadastuximab talirine.
As a result, Seattle Genetics, the drug’s manufacturers, have said that they will resume two of the phase I trials in AML. One of these phase I trials is designed to evaluate the safety profile of vadastuximab talirine in combination with hypomethylating agents in newly diagnosed and relapsed AML patients (NCT01902329). The other phase I trial is designed to assess the safety profile of vadastuximab in combination treatment with standard of care, or 7+3 chemotherapy, in newly diagnosed younger AML patients (NCT02326584). However, the phase I/II clinical trials of vadastuximab talirine in pre- and post-AHCT patients will not be resumed.
Nonetheless, the phase III CASCADE trial in older AML patients is still proceeding with enrolment.
References