NCT03301597

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Nohla Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
BIOLOGICAL	NLA101	NLA101 is a universal donor "off-the-shelf" ex-vivo expanded hematopoietic stem and progenitor cell (HSPC) product that is cryopreserved and ready for immediate use.
DRUG	Standard of Care (SOC) chemotherapy	The SOC chemotherapy regimen for each patient will be determined by local PI. Regimen must be a standard AML regimen that will result in moderate to severe myelosuppression and have curative intent.

Timeline

• Start date: 2018-01-24
• Primary completion: 2019-03-18
• Completion: 2019-03-18
• First posted: 2017-10-04
• Last updated: 2021-03-30

Locations

36 sites across 3 countries: United States, Australia, South Korea

Regulatory

• FDA-regulated drug study