Miami Cancer Institute Launches Two FDA-Approved Clinical Trials for Patients with Blood Cancers Who Undergo Stem Cell Transplantation

Miami Cancer Institute, part of Baptist Health South Florida, has begun enrolling patients in two investigator-led clinical trials for patients with leukemia, multiple myeloma and other blood cancers whose treatment includes stem cell transplantation. Guenther Koehne, M.D., Ph.D., deputy director and chief of Blood & Marrow Transplantation and Hematologic Oncology at Miami Cancer Institute, designed the studies in an effort to improve care and extend the lives of very high-risk patients.

“While we have made rapid advancements in stem cell transplantation, these are complex patients who require a very comprehensive approach to care,” says Dr. Koehne. “I am always looking for new and better treatment options to decrease the rate of relapse and reduce the chance of infection, which are two of the most common causes of death and complications for these patients.”

As a pioneer in the field, Dr. Koehne developed a technique to manipulate donor cells to reduce the often deleterious graft-versus-host disease complication of transplantation. His work has not only improved outcomes but has also made it possible for more patients, especially elderly patients who previously would not have been considered for transplantation, to receive the treatment.

The trials are unique to Miami Cancer Institute and are possible because the Institute’s high-tech lab is equipped with the most sophisticated equipment operated by dedicated, highly qualified personnel. Only the most advanced cancer programs have onsite labs capable of cell manipulation and cellular therapies such as those developed by Dr. Koehne.

Recently, the Institute’s Blood & Marrow Stem Cell Transplant Program received accreditation from the Foundation for the Accreditation of Cellular Therapy (FACT). FACT-certified programs meet rigorous quality and safety standards. The Institute began offering autologous (cells from the patient’s own body) stem cell transplants in 2018 and in 2019 began its allogeneic (donor cells) transplant program. 

Boosting survival rates for AML patients with FLT3 genetic mutation

In one clinical trial, Dr. Koehne and his team are studying a novel therapy for patients with acute myeloid leukemia (AML), which he calls an especially aggressive leukemia. “Some 30 percent of patients with AML have an FLT3 genetic mutation that causes higher rates of relapse and lower rates of survival than for AML patients without the mutation,” Dr. Koehne says.

The trial combines two different drugs administered in the induction stage, when the patient receives chemotherapy to kill cancer cells in the bone marrow prior to a stem cell transplant, and again in the consolidation stage, to help the patient maintain remission and prevent relapse.

“While the drugs in the trial have been tested and found safe, the combination has not been tried before,” Dr. Koehne says. “We are hopeful that the combination of drugs will lead to complete remission.”

Studying the levels and timing of T-cells given after transplantation

In a second clinical trial, Dr. Koehne’s team is studying the use of varying levels of manipulated T-cells (using those with the ability to fight viruses) given after transplantation, as well as the timing of when they are administered, in order to assess their ability to reduce disease relapse and viral infections.

“We have greatly reduced the occurrence of graft-versus-host disease with the T-cell manipulation we developed in the past,” Dr. Koehne notes. “I am quite optimistic that by using additional forms of T-cells that we carefully select and purify, we can reduce viral complications.”

Dr. Koehne believes the trials will prompt larger studies and result in changes to the standards of care used today. “Clinical trials lead to new treatments,” he says. “In order to develop the most effective treatments, we must evaluate these innovative therapies.” More information on clinical trials at Miami Cancer Institute can be found here.