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

Nohla Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Leukemia, Myeloid, Acute

Treatments: Biological: NLA101; Drug: Standard of Care (SOC) chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03301597

NLA-0101-CIN-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 4 patient groups

Control Arm

Other group

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.

Treatment:

Drug: Standard of Care (SOC) chemotherapy

Low Dose Arm

Experimental group

Description:

The Low Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of low-dose NLA101.

Treatment:

Biological: NLA101

Drug: Standard of Care (SOC) chemotherapy

Medium Dose Arm

Experimental group

Description:

The Medium Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of medium-dose NLA101.

Treatment:

Biological: NLA101

Drug: Standard of Care (SOC) chemotherapy

High Dose Arm

Experimental group

Description:

The High Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of high-dose NLA101.

Treatment:

Biological: NLA101

Drug: Standard of Care (SOC) chemotherapy