NLA101 in Adults Receiving High Dose Chemotherapy for AML
- Conditions
- Leukemia, Myeloid, Acute
- Interventions
- Biological: NLA101Drug: Standard of Care (SOC) chemotherapy
- Registration Number
- NCT03301597
- Lead Sponsor
- Nohla Therapeutics, Inc.
- Brief Summary
Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and efficacy of NLA101 to reduce the rate of infections associated with CIN in adult subjects with AML.
- Detailed Description
Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and efficacy of NLA101 to reduce the rate of infections associated with chemotherapy induced neutropenia (CIN) in adult subjects with AML.
Eligible subjects with untreated de novo or secondary AML and per local institutional standards planned to receive at least two cycles of chemotherapy with curative intent will be enrolled into the study and randomized 1:1:1:1 to 1 of 3 Investigational Arms (Standard of Care \[SOC\] chemotherapy + low, medium, or high dose NLA101) or a Control Arm (SOC chemotherapy).
Subjects randomized to an Investigational Arm will be eligible to receive a single fixed assigned dose of NLA101 after the first cycle of chemotherapy, and up to 2 additional identical cell doses after subsequent chemotherapy cycles (one NLA101 infusion per cycle). Subjects randomized to the Control Arm will be followed for up to 3 cycles of chemotherapy.
All subjects will be followed for 84 days following randomization, or 30 days post final infusion of NLA101, or 30 days post the day after the last chemotherapy infusion for Control Arm, whichever is longer.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 146
- Age ≥ 18 (or legal age of majority for sites outside US).
- Untreated de novo or secondary acute myeloid leukemia (AML), including AML that has progressed from myelodysplastic syndrome (MDS), and histologically documented diagnosis
- Eligible for at least 2 cycles of standard of care AML chemotherapy that will result in moderate to severe myelosuppression and have curative intent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 or Karnofsky Status of 50 to 100.
- Adequate cardiac, renal, and hepatic functions.
- Extramedullary disease in the absence of bone marrow or blood involvement
- Acute promyelocytic leukemia (APL) with PML-RARA
- Prior AML therapy, with the exception of intrathecal chemotherapy or emergent radiation for myeloid sarcoma.
- Concurrent malignancy requiring active treatment with chemotherapy, immunotherapy, or radiation
- Prior allotransplant, including allogeneic hematopoietic cell transplant or solid organ allogeneic transplant
- Known hypersensitivity or history of hypersensitivity to dimethylsulfoxide (DMSO)
- Active/chronic human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low Dose Arm Standard of Care (SOC) chemotherapy The Low Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of low-dose NLA101. Control Arm Standard of Care (SOC) chemotherapy The Control Arm will receive standard of care (SOC) chemotherapy without the infusion of NLA101. SOC chemotherapy will be determined by local PI and must be a standard regimen for untreated de novo or secondary AML that will result in moderate to severe myelosuppression and will be given with curative intent. High Dose Arm NLA101 The High Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of high-dose NLA101. Medium Dose Arm NLA101 The Medium Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of medium-dose NLA101. Medium Dose Arm Standard of Care (SOC) chemotherapy The Medium Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of medium-dose NLA101. High Dose Arm Standard of Care (SOC) chemotherapy The High Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of high-dose NLA101. Low Dose Arm NLA101 The Low Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of low-dose NLA101.
- Primary Outcome Measures
Name Time Method Recurrent Event Rate of Grade 3 or Higher Bacterial or Fungal Infection From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later
- Secondary Outcome Measures
Name Time Method Event rate of grade 3 or higher documented bacterial and fungal infections per cycle of chemotherapy From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later Incidence and duration of complications due to infections From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later Incidence and duration of febrile neutropenia From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later Incidence and duration of filgrastim (or biosimilar) administration From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later Overall Response Rate From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later
Trial Locations
- Locations (36)
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Winship Cancer Institute, Emory University
🇺🇸Atlanta, Georgia, United States
Stony Brook University
🇺🇸Stony Brook, New York, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Duke University Heath System, Duke Cancer Center
🇺🇸Durham, North Carolina, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
USC Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Norton Cancer Institute, St. Matthews Campus
🇺🇸Louisville, Kentucky, United States
Icahn School of Medicine at Mount Sinai and Mount Sinai Health System
🇺🇸New York, New York, United States
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
University of California Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Nebraska Medical Center - Fred & Pamela Buffett Cancer Center
🇺🇸Omaha, Nebraska, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Westchester Medical Center
🇺🇸Hawthorne, New York, United States
Weill Cornell Medical College - NewYork-Presbyterian Hospital
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
St. Vincent's Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
West Penn Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Froedtert Hospital and The Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Calvary Mater Newcastle
🇦🇺Waratah, New South Wales, Australia
St. George Hospital
🇦🇺Kogarah, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Epworth HealthCare
🇦🇺Richmond, Victoria, Australia
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea's Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of