NLA101 in Adults Receiving High Dose Chemotherapy for AML
NCT ID: NCT03301597
Last Updated: 2021-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
146 participants
INTERVENTIONAL
2018-01-24
2019-03-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Proteins in Promoting Chemotherapy Resistance in Samples From Patients With Acute Myeloid Leukemia
NCT01419496
Drug Biomarkers in Cell Samples From Patients With Acute Myeloid Leukemia
NCT01150058
Erlotinib Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT01664897
High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia
NCT02551718
Low-Dose Daunorubicin in Relapsed/Refractory Acute Leukemia
NCT02914977
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control Arm
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.
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.
Low Dose Arm
The Low Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of low-dose NLA101.
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.
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.
Medium Dose Arm
The Medium Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of medium-dose NLA101.
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.
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.
High Dose Arm
The High Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of high-dose NLA101.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nohla Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Martin S Tallman, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Naval G Daver, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UC San Diego Moores Cancer Center
La Jolla, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Nebraska Medical Center - Fred & Pamela Buffett Cancer Center
Omaha, Nebraska, United States
Westchester Medical Center
Hawthorne, New York, United States
Weill Cornell Medical College - NewYork-Presbyterian Hospital
New York, New York, 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
Stony Brook University
Stony Brook, New York, United States
Duke University Heath System, Duke Cancer Center
Durham, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Froedtert Hospital and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
St. George Hospital
Kogarah, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Austin Health
Heidelberg, Victoria, Australia
Epworth HealthCare
Richmond, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea's Seoul St. Mary's Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NLA-0101-CIN-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.