NLA101 in Adults Receiving High Dose Chemotherapy for AML

Stopped early · Phase 2

Conditions studied: Leukemia, Myeloid, Acute

In brief

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.

Key facts

Study ID

NCT03301597

Run by

Nohla Therapeutics, Inc.

People needed

146

Starts

2018-01-24

Expected to finish

2019-03-18

Last updated by the study team

2021-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UC San Diego Moores Cancer Center — La Jolla, California, United States
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Norton Cancer Institute, St. Matthews Campus — Louisville, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Nebraska Medical Center - Fred & Pamela Buffett Cancer Center — Omaha, Nebraska, United States
• Westchester Medical Center — Hawthorne, New York, United States
• Weill Cornell Medical College - NewYork-Presbyterian Hospital — New York, New York, United States
• Icahn School of Medicine at Mount Sinai and Mount Sinai Health System — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Stony Brook University — Stony Brook, New York, United States
• Duke University Heath System, Duke Cancer Center — Durham, North Carolina, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• West Penn Hospital — Pittsburgh, Pennsylvania, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Froedtert Hospital and The Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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