Study Stopped
Development plan under review.
NLA101 in Adults Receiving High Dose Chemotherapy for AML
LAUNCH
A Phase 2 Open-Label, Multi-Center, Randomized, Controlled, Dose-Finding Study of NLA101 in Adults Receiving High Dose Chemotherapy for Acute Myeloid Leukemia
1 other identifier
interventional
146
3 countries
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2018
Shorter than P25 for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2017
CompletedFirst Posted
Study publicly available on registry
October 4, 2017
CompletedStudy Start
First participant enrolled
January 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2019
CompletedMarch 30, 2021
March 1, 2021
1.1 years
September 27, 2017
March 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
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
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
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
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
Study Arms (4)
Control Arm
OTHERThe 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.
Low Dose Arm
EXPERIMENTALThe Low Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of low-dose NLA101.
Medium Dose Arm
EXPERIMENTALThe Medium Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of medium-dose NLA101.
High Dose Arm
EXPERIMENTALThe High Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of high-dose NLA101.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, 40207, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Nebraska Medical Center - Fred & Pamela Buffett Cancer Center
Omaha, Nebraska, 68198, United States
Westchester Medical Center
Hawthorne, New York, 10532, United States
Weill Cornell Medical College - NewYork-Presbyterian Hospital
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai and Mount Sinai Health System
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Stony Brook University
Stony Brook, New York, 11794, United States
Duke University Heath System, Duke Cancer Center
Durham, North Carolina, 27710, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Froedtert Hospital and The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
St. George Hospital
Kogarah, New South Wales, 2217, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Epworth HealthCare
Richmond, Victoria, 3121, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea's Seoul St. Mary's Hospital
Seoul, 06591, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Martin S Tallman, MD
Memorial Sloan Kettering Cancer Center
- STUDY CHAIR
Naval G Daver, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- This is an open-label study.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2017
First Posted
October 4, 2017
Study Start
January 24, 2018
Primary Completion
March 18, 2019
Study Completion
March 18, 2019
Last Updated
March 30, 2021
Record last verified: 2021-03