Dr. Perales on the PROGRESS II Trial in Hematologic Malignancies

Miguel-Angel Perales, MD, deputy chief, Adult Bone Marrow Transplant Service, director, Adult Bone Marrow Transplantation Fellowship Program, Memorial Sloan Kettering Cancer Center, provides an overview of the PROGRESS II trial, which was conducted for patients with hematologic malignancies.

This randomized phase III multicenter study was designed with 3 arms, comparing 2 calcineurin inhibitor (CNI)-free strategies for graft-versus-host disease (GVHD) prophylaxis to standard tacrolimus and methotrexate in patients with hematologic malignancies who are also undergoing myeloablative conditioning hematopoietic stem cell transplantation.

One of the treatment arms, explains Perales, involves a standard regimen of tacrolimus and methotrexate. The second, experimental treatment arm is based on strategies developed at Memorial Sloan Kettering Cancer, using CD34-seleced peripheral blood stem cell graft. In the third treatment arm, patients receive posttransplant cyclophosphamide.

One of the interesting findings thus far is the predictive nature of the comorbidity index as it relates to outcomes for these patients. According to Perales, when looking at the hematopoietic cell transplantation-comorbidity index, there are normally 3 different groups characterized by low risk, intermediate risk, and high risk. With CD34 selection in this study, the results of the low risk and intermediate groups actually tracked together, and they each experienced better outcomes.

These findings suggest that, with CD34 selection, in the absence of calcineurin inhibitors or methotrexate, the toxicity of the transplant can be minimized, allowing for more intense transplants in older patients.