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 CIN in adult subjects
with AML.
Title
- Brief Title: NLA101 in Adults Receiving High Dose Chemotherapy for AML
- Official Title: A Phase 2 Open-Label, Multi-Center, Randomized, Controlled, Dose-Finding Study of NLA101 in Adults Receiving High Dose Chemotherapy for Acute Myeloid Leukemia
Clinical Trial IDs
- ORG STUDY ID:
NLA-0101-CIN-01
- NCT ID:
NCT03301597
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| NLA101 | Dilanubicel | High Dose Arm |
| Standard of Care (SOC) chemotherapy | | Control Arm |
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.
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 adult subjects with AML.
Eligible subjects with untreated de novo or secondary AML and per local institutional
standards planned to receive at least two cycles of chemotherapy with curative intent will be
enrolled into the study and randomized 1:1:1:1 to 1 of 3 Investigational Arms (Standard of
Care [SOC] chemotherapy + low, medium, or high dose NLA101) or a Control Arm (SOC
chemotherapy).
Subjects randomized to an Investigational Arm will be eligible to receive a single fixed
assigned dose of NLA101 after the first cycle of chemotherapy, and up to 2 additional
identical cell doses after subsequent chemotherapy cycles (one NLA101 infusion per cycle).
Subjects randomized to the Control Arm will be followed for up to 3 cycles of chemotherapy.
All subjects will be followed for 84 days following randomization, or 30 days post final
infusion of NLA101, or 30 days post the day after the last chemotherapy infusion for Control
Arm, whichever is longer.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Control Arm | Other | 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. | - Standard of Care (SOC) chemotherapy
|
| Low Dose Arm | Experimental | The Low Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of low-dose NLA101. | - NLA101
- Standard of Care (SOC) chemotherapy
|
| Medium Dose Arm | Experimental | The Medium Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of medium-dose NLA101. | - NLA101
- Standard of Care (SOC) chemotherapy
|
| High Dose Arm | Experimental | The High Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of high-dose NLA101. | - NLA101
- Standard of Care (SOC) chemotherapy
|
Eligibility 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Recurrent Event Rate of Grade 3 or Higher Bacterial or Fungal Infection |
| Time Frame: | From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Event rate of grade 3 or higher documented bacterial and fungal infections per cycle of chemotherapy |
| Time Frame: | From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence and duration of filgrastim (or biosimilar) administration |
| Time Frame: | From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later |
| Safety Issue: | |
| Description: | |
| Measure: | Overall Response Rate |
| Time Frame: | From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence and duration of complications due to infections |
| Time Frame: | From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence and duration of febrile neutropenia |
| Time Frame: | From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Terminated |
| Lead Sponsor: | Nohla Therapeutics, Inc. |
Trial Keywords
- Chemotherapy-induced Neutropenia
- Bacterial Infections
- Fungal Infections
Last Updated
March 30, 2021
