The National Cancer Institute (NCI) at the National Institutes of Health is currently enrolling participants for a stem cell transplant clinical trial. The phase II/III trial is intended to study an autologous (taken from the person’s own body) peripheral blood stem cell transplant for both non-Hodgkin (NHL) and Hodgkin lymphoma (HL).
Phase II trials are designed to measure efficacy and safety testing, typically in a small numbers of participants and to see how much of a treatment should be used. Phase III trials are required for a drug or other treatment to receive approval for use. The purpose of Phase III is to test efficacy (effectiveness) and safety as well as to monitor for side effects. This study is a combination of both phases of clinical testing.
According to the Leukemia Research Foundation “Every four minutes, someone is diagnosed with blood cancer – more than 201,870 new cases are expected this year in the United States.” New treatments for blood cancers, such as lymphoma–both NHL and HL–are greatly needed with stem cell therapies hopefully accounting as one solution. By using autologous cells taken from an individual’s own body, clinicians can prevent rejection of the transplant.
The main objectives of the study will be to measure if the transplant improves survival in people with these types of lymphomas and also to determine whether the treatment is ultimately safe for both people with HIV infection and those with relapsed cancer. Participants will be individuals with NHL or HL who are under the age of 70 and hematologist Dr. Veronika Bachanova of the University of Minnesota will lead the study.
The treatment will involve giving participants granulocyte colony stimulating factor (G-CSF). According to the NCI “G-CSF helps stem cells move from the patient’s bone marrow to the blood so they can be collected and stored for peripheral stem cell transplant.” Study subjects will also receive chemotherapy and total-body irradiation to remove cancerous blood-forming cells in the bone marrow. The researchers will then inject the stem cells back, this way replacing cancerous blood-forming cells. Participants will also receive more radiation after the transplant to destroy any remaining cancer cells.
The study has been ongoing since 2005, however the investigators are currently admitting more participants and they estimate the trial will completed by December of 2016. In total, the team plans to study 325 individuals using this stem cell approach.
People who are interesting in participating in this study can contact: