Norton Cancer Institute researching how to reduce infections linked to treating AML

Nohla Therapeutics initiates Phase 2 LAUNCH clinical trial to assess optimal dosage of innovative cell therapy for those with acute myeloid leukemia.

A treatment made from umbilical cord blood is helping oncology and hematology specialists at Norton Cancer Institute reduce infections in patients getting high-dose chemotherapy to treat acute myeloid leukemia (AML).

AML is a type of cancer in which the bone marrow makes abnormal myeloblasts, a kind of white blood cell, plus abnormal red blood cells and platelets. The intensive chemotherapy needed to treat AML commonly triggers infections that can become life-threatening.

Don A. Stevens, M.D., hematologist/oncologist with Norton Cancer Institute, described what happens using the example of a garden: Imagine our bone marrow is a garden that grows blood cells. Some plants grow red cells to carry oxygen; other plants grow platelets to help with blood clotting; and others grow white blood cells to fight infections.

“Leukemia cells are akin to weeds that choke out the growth of normal plants,” Dr. Stevens said.

Oncologists use chemotherapy to kill these “leukemia weeds,” however those powerful drugs also lower normal blood cell counts.

“In our garden example, the treatment temporarily decreases the growth of our normal plants,”he said. “While we’re waiting for the normal plants to regrow, there is an increased risk of infection.”

Stem cell treatment to rebuild AML patients’ infection-fighters

To help solve this problem, Norton Cancer Institute is taking part in a clinical trial announced earlier this year by Nohla Therapeutics, Inc.  The Phase 2 LAUNCH trial is evaluating Nohla’s lead product candidate, dilanubicel (NLA101), in adult patients with AML who are at risk for chemotherapy-related infection. This is an open-label, multi-center, controlled, dose-finding clinical trial.

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The LAUNCH trial will enroll approximately 220 adult patients in order to evaluate dilanubicel’s ability to reduce the rate of high-risk infections. The study will strive to identify the product’s lowest effective cell dose.

Dilanubicel was developed to provide short-term, temporary bone marrow function until a patient’s immune system recovers, with no need for complex HLA protein matching. Over 150 infusions of the product have been administered across six clinical trials since 2006. This therapy has shown potential to overcome the broad safety and logistical risks of patient-specific cell therapies that are customized for individual patients.

According to Joseph J. Maly, M.D., principal investigator for the study and hematologist/oncologist with Norton Cancer Institute, options for treating AML have improved in recent years, yet patients still can face significant complications.

“Our aim is to avoid infections that can lead to longer hospitalizations and delays in care for our patients,” Dr. Maly said. “In the example of the garden, the treatment acts as temporary plants that grow cells for patients while we are waiting for their own plants to regrow.”

Additional information about the LAUNCH trial (NCT03301597) can be found at ClinicalTrials.gov.


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