In patients with acute myeloid leukemia (AML) undergoing induction, presence and persistence of infections can delay antineoplastic therapy which can affect overall survival. The safety and efficacy of CLT-008, an off-the-shelf human allogeneic myeloid progenitor cell, as a measure to reduce infections after induction chemotherapy for patients with AML was investigated in a randomized controlled phase II study. At the 23rd Congress of the European Hematology Association, on behalf of colleagues, Pinkal Desai, Weill Cornell Medicine, presented the results of this phase II study.
Ninety-four patients with newly diagnosed AML were randomized 1:1 to receive standard 7 + 3 (cytarabine and an anthracycline) induction chemotherapy with granulocyte-colony stimulating factor (G-CSF, starting on Day 14 [control]) alone (n = 46, median age = 64 years) or CLT-008 (7.5 x 106 cells/kg on day 9) plus G-CSF (n = 48). The primary endpoint of the study was days in a febrile episode from Day 9–28. The secondary endpoints of the study were the incidence of infections, therapeutic use of antimicrobials, hematologic recovery and morbidity & mortality.
- Median days of a febrile episode during Day 9–28 in evaluable patients in the control and treatment arms were 8.0 and 7.0 days respectively, P = 0.0984
- Median days of a febrile episode during Day 15–28 in evaluable patients in the control and treatment arms were 3.0 and 2.0 days respectively, P = 0.0570
- During Day 9–28, there was a 35% decrease in bacterial/fungal infections in patients in the CLT-008 treated arm compared to control, P = 0.0571
- During Day 15–28, there was a 73% decrease in bacterial/fungal infections in evaluable patients in the CLT-008 treated (n = 39) arm compared to control (n = 39), P = 0.0098
- There was a decrease in the use of antimicrobial agents during induction in evaluable patients in the CLT-008 treated arm compared to control
- Patients in the CLT-008 arm had a decreased number of total days in hospital compared to control by 3 days, P = 0.0059
- No infectious deaths were observed in the CLT-008 treated arm; there were two deaths in the control arm as a result of pneumonia
In summary, the incidence of infections, use of antibacterial agents and days in hospital were decreased in patients receiving CLT-008. The speaker, Dr. Desai in an interview with the AGP, stated that the results of this phase II study are significant as CLT-008 was able to reduce infections by 73% which represents an unmet need in AML induction that provides supportive care in order to ensure elderly AML patients can go through AML induction therapy. Dr. Desai further concluded that “myeloid progenitors may provide a new option to reduce infections in AML patients undergoing induction therapy”.