Clinical Trials /

NLA101 in Adults Receiving High Dose Chemotherapy for AML

NCT03301597

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

  • Leukemia, Myeloid, Acute

Interventions

DrugSynonymsArms
NLA101DilanubicelLow Dose Arm
Standard of Care (SOC) chemotherapyControl 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

NameTypeDescriptionInterventions
Control ArmOtherThe 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 ArmExperimentalThe Low Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of low-dose NLA101.
  • Standard of Care (SOC) chemotherapy
Medium Dose ArmExperimentalThe Medium Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of medium-dose NLA101.
  • Standard of Care (SOC) chemotherapy
High Dose ArmExperimentalThe High Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of high-dose 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 grade 3 or higher fever or hypothermia
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:Recruiting
Lead Sponsor:Nohla Therapeutics, Inc.

Trial Keywords

  • Chemotherapy-induced Neutropenia
  • Bacterial Infections
  • Fungal Infections

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