Clinical trial · Interventional
NLA101 in Adults Receiving High Dose Chemotherapy for AML
A Phase 2 Open-Label, Multi-Center, Randomized, Controlled, Dose-Finding Study of NLA101 in Adults Receiving High Dose Chemotherapy for Acute Myeloid Leukemia
NCT03301597CI-TRIAL-00050952LAUNCHterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Development plan under review.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NLA101 | Biological | — | UNRESOLVED |
| Standard of Care (SOC) chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- Control Arm
- description
- The Control Arm will receive standard of care (SOC) chemotherapy without the infusion of NLA101. SOC chemotherapy will be determined by local PI and must be a standard regimen for untreated de novo or secondary AML that will result in moderate to severe myelosuppression and will be given with curative intent.
- interventionNames
- Drug: Standard of Care (SOC) chemotherapy
- type
- EXPERIMENTAL
- label
- Low Dose Arm
- description
- The Low Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of low-dose NLA101.
- interventionNames
- Biological: NLA101
- Drug: Standard of Care (SOC) chemotherapy
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.