Baptist Health South Florida

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

March 1, 2022

New investigator-led research seeks to improve outcomes and survival in high-risk blood cancer patients

MIAMI – March 1, 2022 – Miami Cancer Institute, part of Baptist Health South Florida, has begun enrolling patients in two investigator-led clinical trials for patients with leukemia 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,” said 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 Blood & Marrow Stem Cell Transplant Program at the Institute received accreditation from the Foundation for the Accreditation of Cellular Therapy (FACT). FACT-certified programs meet vigorous 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.

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 said. “In order to develop the most effective treatments, we must evaluate these innovative therapies.”

The two trials are:

A Pilot Study of Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) as Induction Therapy for Patients with FLT3 Mutated Acute Myeloid Leukemia followed by Consolidation with a CD34+-selected Allograft – Some 30 percent of patients with acute myeloid leukemia (AML) have an FLT3 genetic mutation. Those with the mutation have higher rates of relapse and lower rates of survival than AML patients without the mutation. “This is an aggressive leukemia,” Dr. Koehne said. “And while the drugs in the trial have been tested and found safe, the combination has not been tried before. We are hopeful that the combination of drugs will lead to complete remission.” The trial involves combining CPX-351 and the FLT3-inhibitor in the induction stage (chemo given to kill cancer cells in the bone marrow before a stem cell transplant) and again in consolidation (to maintain remission and prevent relapse).

A Phase 1 Dose Escalation Trial of T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients with Lymphoid, Myeloid or Plasma Cell Malignancies – The goal of this study is to test varying levels of manipulated T-cells (using those with the ability to fight viruses) given after transplantation 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 said. “I am quite optimistic that by using additional forms of T-cells that we carefully select and purify, we can reduce viral complications.” The trial is testing both the timing and amount of T-cell Receptor α/β Depleted Donor Lymphocyte Infusions.

For more information on how to enroll in a clinical trial at Miami Cancer Institute, go to

Dr. Koehne will be presenting on his latest research and industry innovations for hematologic malignancies at Miami Cancer Institute’s Third Miami Cancer Institute Summit of the Americas on Immunotherapies for Hematologic Malignancies. To register or for more information on this event, go to

About Miami Cancer Institute

Miami Cancer Institute, part of Baptist Health South Florida, brings to South Florida access to personalized clinical treatments and comprehensive support services delivered with unparalleled compassion. No other cancer program in the region has the combination of cancer-fighting expertise and advanced technology—including the first proton therapy center in South Florida, Latin America and the Caribbean, and one of the only radiation oncology program in the world with each of the newest radiation therapies in one place—to diagnose and deliver precise cancer treatments that achieve the best outcomes and improve the lives of cancer patients. The Institute offers an impressive roster of established community oncologists and renowned experts, clinical researchers and genomic scientists recruited from the nation’s top cancer centers. Selected as Florida’s only member of the Memorial Sloan Kettering Cancer (MSK) Alliance, Miami Cancer Institute is part of a meaningful clinical collaboration that affords patients in South Florida access to innovative treatments and ensures that the standards of care developed by their multidisciplinary disease management teams match those at MSK.

Miami Cancer Institute is part of Baptist Health South Florida, the largest healthcare organization in the region, with 12 hospitals, more than 24,000 employees, 4,000 physicians and 100 outpatient centers, urgent care facilities and physician practices spanning across Miami-Dade, Monroe, Broward and Palm Beach counties. Baptist Health has internationally renowned centers of excellence in cancer, cardiovascular care, orthopedics and sports medicine, and neurosciences. In addition, it includes Baptist Health Medical Group; Baptist Health Quality Network; and Baptist Health Care On Demand, a virtual health platform. A not-for-profit organization supported by philanthropy and committed to its faith-based charitable mission of medical excellence, Baptist Health has been recognized by Fortune as one of the 100 Best Companies to Work For in America and by Ethisphere as one of the World’s Most Ethical Companies. For more information, visit and connect with us on Facebook, Instagram, Twitter and LinkedIn.




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