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Active Clinical Trials

NLA101 in Adults Receiving High Dose Chemotherapy for AML (LAUNCH)

Active NCT:
03301597
West Penn Hospital
West Penn Hospital

Sponsor: 
Nohla Therapeutics, Inc.
Contact: 

For more information, please contact Rich Wonder at 412-578-4492 or Rich.Wonder@ahn.org or Melissa McMillen by telephone at 412-578-4493 or Melissa.McMillen@ahn.org.

NLA101 in Adults Receiving High Dose Chemotherapy for AML (LAUNCH)

Purpose: 

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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