Juno Pharmaceutics has terminated phase II of a clinical trial for a cancer chemotherapy following two fatalities in a week.
Juno Therapeutics announced putting on hold the phase II of its clinical trial, dubbed as “ROCKET,” after two patients enrolled in the study died in a week. The firm terminated the trial for the second time this year following the deaths of participants enrolled in the study.
The chemotherapy trial aimed to develop a new treatment for patients with acute lymphoblastic leukemia. Patients with either relapsed or refractory B cell lymphoblastic leukemia took part in the study.
In July this year, the U.S. Food and Drug Administration (FDA) directed Juno to put on hold the trial. The drug regulatory agency did so due to cases of three patients dying during the study.
Juno CEO Hans Bishop said that two more patients enrolled in the treatment developed cerebral edema, CNN reported. Cerebral edema is a swelling of the skull, often a result of excessive cranial fluid.
The Danger of JCAR015 Cells
Part of the ROCKET study was the administration of JCAR015 with cyclophosphamide pre-conditioning alone. The FDA granted the permit, allowing Juno to use the treatment without fludarabine.
CNN report noted that the combination of fludarabine and the genetically-modified JCAR015 cell can be fatal. The FDA noted that adverse effects of drug trials are extremely rare.
Data from the National Cancer Institute (NCI) revealed that around 77,855 individuals are living with acute lymphoblastic leukemia in the U.S. as of 2013. Around 6,590 new cases of acute lymphoblastic leukemia were added in the U.S. in 2016 alone. It is most common among children, adolescents, and young adults. This makes acute lymphoblastic leukemia one of the most common cancers among this age group.