NLA101 in Adults Receiving High Dose Chemotherapy for AML

• Status: Terminated
• Trial end date: 2019-03-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nohla Therapeutics, Inc.

Criteria

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