At the recent European Hematology Association Congress in Stockholm, Cellerant Therapeutics, Inc. presented results from their Phase 2 clinical trial of CLT-008, an allogeneic myeloid progenitor cell (MPC) for treating severe neutropenia, a side effect of induction chemotherapy which leaves patients vulnerable to infection. The implications of these results may be to allow for the wider use of induction chemotherapy.
Acute myeloid leukaemia (AML), an aggressive blood and bone marrow cancer, has a significantly lower survival rate for older patients aged 65 upwards, largely due to the infection risk arising from induction chemotherapy induced neutrophia. The Phase 2 trial was conducted on 163 newly diagnosed AML patients aged 55 or older who were recipients of either “7+3” or “HiDAC” induction chemotherapy. They were then randomized 1:1 to be treated with either CLT-008 plus granulocyte colony stimulating factor (G-CSF) (the treated group) or with only G-CSF (control). After 9 days post chemotherapy CLT-008 was given to the treated group, and G-CSF delivered to both groups approximately 14 days after chemotherapy. Day 15 onwards is when CLT-008’s biological effect is expected to be observed. Patients were monitored for 42 days post chemotherapy initiation, with 120 patients evaluable for efficacy analysis from day 15-28.
The major findings of the study were that CLT-008 reduced the incidence of serious infections in the treated group (73% less), and the treated group were in hospital for 3.2 less days than the control. Furthermore, 29% less patients in the treated group received antimicrobial agents for diagnosed infection. As for safety, there were no safety concerns and serious adverse events incidence were similar in both groups.
Dr. Pinkal Desai, Assistant Professor of Medicine, Weill Cornell Medicine and one of the principal investigators of the study, commented on the findings “The exciting results from this study show that this innovative approach to treatment of infections could allow more patients to safely survive optimal induction chemotherapy treatment and survive longer, particularly many elderly patients who are not offered induction chemotherapy due to the risk of infection,”.
Source: Cellerant Therapeutics, Inc. Presents Phase 2 Results Showing CLT-008 Significantly Reduces Risk of Infections in AML Patients Undergoing Standard Induction Chemotherapy; Press Release
Source: Cellerant Therapeutics, Inc. CLT-008 Phase 2 Results Show Significant Reduction in Infections and Days in Hospital in Severely Neutropenic AML Patients; Press Release