NLA101 in Adults Receiving High Dose Chemotherapy for AML

Leukemia, Myeloid, Acute Clinical Trial

— LAUNCH  

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 Details — Status: Terminated

Administrative data

• NCT number: NCT03301597
• Other study ID #: NLA-0101-CIN-01
• Status: Terminated
• Phase: Phase 2
• Start date: January 24, 2018
• Est. completion date: March 18, 2019

Study information

• Verified date: March 2021
• Source: Nohla Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 146
• Est. completion date: March 18, 2019
• Est. primary completion date: March 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	St. Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	Austin Health	Heidelberg	Victoria
Australia	St. George Hospital	Kogarah	New South Wales
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Epworth HealthCare	Richmond	Victoria
Australia	Calvary Mater Newcastle	Waratah	New South Wales
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea's Seoul St. Mary's Hospital	Seoul
United States	Winship Cancer Institute, Emory University	Atlanta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Duke University Heath System, Duke Cancer Center	Durham	North Carolina
United States	Westchester Medical Center	Hawthorne	New York
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California
United States	Norton Cancer Institute, St. Matthews Campus	Louisville	Kentucky
United States	University of Wisconsin	Madison	Wisconsin
United States	Loyola University Medical Center	Maywood	Illinois
United States	Froedtert Hospital and The Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Icahn School of Medicine at Mount Sinai and Mount Sinai Health System	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Weill Cornell Medical College - NewYork-Presbyterian Hospital	New York	New York
United States	University of Nebraska Medical Center - Fred & Pamela Buffett Cancer Center	Omaha	Nebraska
United States	West Penn Hospital	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California Davis Comprehensive Cancer Center	Sacramento	California
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Swedish Cancer Institute	Seattle	Washington
United States	Stony Brook University	Stony Brook	New York
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Nohla Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent Event Rate of Grade 3 or Higher Bacterial or Fungal Infection		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
Secondary	Event rate of grade 3 or higher documented bacterial and fungal infections per cycle of chemotherapy		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
Secondary	Incidence and duration of filgrastim (or biosimilar) administration		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
Secondary	Overall Response Rate		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
Secondary	Incidence and duration of complications due to infections		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
Secondary	Incidence and duration of febrile neutropenia		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