Status:
TERMINATED
NLA101 in Adults Receiving High Dose Chemotherapy for AML
Lead Sponsor:
Nohla Therapeutics, Inc.
Conditions:
Leukemia, Myeloid, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Key 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
- 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
Key Trial Info
Start Date :
January 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2019
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT03301597
Start Date
January 24 2018
End Date
March 18 2019
Last Update
March 30 2021
Active Locations (36)
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1
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
2
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
4
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224