Back to resultsNLA101 in Adults Receiving High Dose Chemotherapy for AML (LAUNCH)
Primary Purpose
Leukemia, Myeloid, Acute
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NLA101
Standard of Care (SOC) chemotherapy
Sponsored by
About this trial
This is an interventional prevention trial for Leukemia, Myeloid, Acute focused on measuring Chemotherapy-induced Neutropenia, Bacterial Infections, Fungal Infections
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
Sites / Locations
- UC San Diego Moores Cancer Center
- USC Norris Comprehensive Cancer Center
- University of California Davis Comprehensive Cancer Center
- Mayo Clinic Florida
- Winship Cancer Institute, Emory University
- University of Chicago Medical Center
- Loyola University Medical Center
- Norton Cancer Institute, St. Matthews Campus
- Massachusetts General Hospital
- Mayo Clinic
- University of Nebraska Medical Center - Fred & Pamela Buffett Cancer Center
- Westchester Medical Center
- Weill Cornell Medical College - NewYork-Presbyterian Hospital
- Icahn School of Medicine at Mount Sinai and Mount Sinai Health System
- Memorial Sloan Kettering Cancer Center
- Stony Brook University
- Duke University Heath System, Duke Cancer Center
- Wake Forest Baptist Health
- Geisinger Medical Center
- West Penn Hospital
- The University of Texas MD Anderson Cancer Center
- Swedish Cancer Institute
- Seattle Cancer Care Alliance
- University of Wisconsin
- Froedtert Hospital and The Medical College of Wisconsin
- St. Vincent's Hospital Sydney
- St. George Hospital
- Calvary Mater Newcastle
- Royal Adelaide Hospital
- Austin Health
- Epworth HealthCare
- Royal Perth Hospital
- Gachon University Gil Medical Center
- Seoul National University Hospital
- Samsung Medical Center
- The Catholic University of Korea's Seoul St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Experimental
Experimental
Experimental
Arm Label
Control Arm
Low Dose Arm
Medium Dose Arm
High Dose Arm
Arm 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.
The Low Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of low-dose NLA101.
The Medium Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of medium-dose NLA101.
The High Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of high-dose NLA101.
Outcomes
Primary Outcome Measures
Recurrent Event Rate of Grade 3 or Higher Bacterial or Fungal Infection
Secondary Outcome Measures
Event rate of grade 3 or higher documented bacterial and fungal infections per cycle of chemotherapy
Incidence and duration of filgrastim (or biosimilar) administration
Overall Response Rate
Incidence and duration of complications due to infections
Incidence and duration of febrile neutropenia
Full Information
NCT ID
NCT03301597
First Posted
September 27, 2017
Last Updated
March 25, 2021
Sponsor
Nohla Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03301597
Brief Title
NLA101 in Adults Receiving High Dose Chemotherapy for AML
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Development plan under review.
Study Start Date
January 24, 2018 (Actual)
Primary Completion Date
March 18, 2019 (Actual)
Study Completion Date
March 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nohla Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute
Keywords
Chemotherapy-induced Neutropenia, Bacterial Infections, Fungal Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized to 1 of 3 Investigational Arms or a Control Arm in a 1:1:1:1 ratio.
Masking
Outcomes Assessor
Masking Description
This is an open-label study.
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
Other
Arm 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.
Arm Title
Low Dose Arm
Arm Type
Experimental
Arm Description
The Low Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of low-dose NLA101.
Arm Title
Medium Dose Arm
Arm Type
Experimental
Arm Description
The Medium Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of medium-dose NLA101.
Arm Title
High Dose Arm
Arm Type
Experimental
Arm Description
The High Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of high-dose NLA101.
Intervention Type
Biological
Intervention Name(s)
NLA101
Other Intervention Name(s)
Dilanubicel
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Standard of Care (SOC) chemotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin S Tallman, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Naval G Daver, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Norton Cancer Institute, St. Matthews Campus
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Nebraska Medical Center - Fred & Pamela Buffett Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Westchester Medical Center
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
Facility Name
Weill Cornell Medical College - NewYork-Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai and Mount Sinai Health System
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Duke University Heath System, Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Froedtert Hospital and The Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
St. Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
St. George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Epworth HealthCare
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea's Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
NLA101 in Adults Receiving High Dose Chemotherapy for AML
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