NLA101 in Adults Receiving High Dose Chemotherapy for AML

Key Criteria:

Inclusion Criteria:

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.

Exclusion Criteria:

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