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Cytokine-induced Memory-like NK Cells

Leukapheresis for Acute Myeloid Leukemia

Phase 1 & 2

Waitlist Available

Led By Amanda Cashen, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is for patients with relapsed or refractory acute myeloid leukemia and myeloid dysplastic syndromes. Doctors will give chemotherapy to patients before giving them an infusion of donor natural killer cells. This is to help stop the growth of cancer cells and keep the patient's immune system from rejecting the donor cells.

Eligible Conditions

Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete Remission Rate (CR/CRi) in Participants With Relapsed or Refractory AML Following CIML NK Therapy (Phase II)

Maximal Tolerated or Tested Dose (MT/TD) of CIML-NK Cells (Phase I)

Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort)

Secondary outcome measures

Disease Free Survival (DFS) (Phase I, Phase II, and Pediatric)

Duration of Remission (DOR) (Phase I, Phase II, and Pediatric)

Overall Survival (OS) (Phase I, Phase II, and Pediatric)

+3 more

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Group I: Phase II (IL-2): Maximum NK cell/number kgExperimental Treatment7 Interventions

The recipient will begin a lymphodepleting preparative regimen of fludarabine and cyclophosphamide on Day -6. The haploidentical donor identified by HLA matching of the immediate family members will undergo non-mobilized large volume (20-L) leukapheresis on Day -1, and the NK cell product will be infused into the recipient on Day 0. Subcutaneous IL-2 will begin approximately 2-4 hours after infusion and will continue every other day through Day 12 for a total of 7 doses.

Group II: Phase I Dose Level 3: Maximum NK cell/number kgExperimental Treatment7 Interventions

Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1. CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0. Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses)

Group III: Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK cellsExperimental Treatment7 Interventions

Group IV: Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK cellsExperimental Treatment7 Interventions

Group V: Pediatric Cohort: Maximum NK cell/number kgExperimental Treatment7 Interventions

Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors on Day -1 CIML NK Cells: Patients undergo CIML NK cell infusion on Day 0 Subcutaneous IL-2 will begin approximately 2-4 hours after infusion and will continue every other day through Day 12 for a total of 7 doses

Group VI: Lead-in Cohort & Phase II (ALT-803): Maximum NK cell/number kgExperimental Treatment7 Interventions

Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4. Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors on Day -1. CIML NK Cells: Patients undergo CIML NK cell infusion on Day 0. Subcutaneous ALT-803 will begin approximately 4 hours after the infusion and will continue for a total of 2 doses (Days 0 and 5).

Group VII: DonorsActive Control1 Intervention

-The haploidentical donor identified by HLA matching of the immediate family members (parents, siblings, and children) will undergo non-mobilized leukapheresis on Day -1. Peripheral blood mononuclear cells (PBMCs) will be collected using standard collection techniques.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

Leukapheresis

2016

Completed Phase 2

~690

Cytokine-induced killer cells

2010

Completed Phase 3

~60

IL-2

2007

Completed Phase 4

~1180

ALT-803

2016

Completed Phase 2

~170

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Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,784 Total Patients Enrolled

American Society of Clinical OncologyOTHER

33 Previous Clinical Trials

147,464 Total Patients Enrolled

American Society of HematologyOTHER

11 Previous Clinical Trials

20,769 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What blood conditions can be helped by Leukapheresis?

"Leukapheresis is the most popular form of treatment for multiple sclerosis but can also help patients with leukemia, myelocytic, acute, retinoblastoma, and histiocytic lymphoma."

Answered by AI

How many individuals are participating in this experiment?

"Unfortunately, this trial is not recruiting patients at the moment. The listing was first posted on August 11th, 2014 and updated as recently as April 14th, 2022. However, there are many other active studies that might be a better match for you. For example, there are 1521 trials actively recruiting leukemia patients and 969 Leukapheresis clinical trials currently enrolling participants."

Answered by AI

What goals does this research aim to achieve?

"The purpose of this long-term study (3 years) is to find the maximum tolerated or tested dose of CIML-NK cells for patients (Phase I). Additionally, researchers will also be looking at secondary outcomes including Response assessed according to IWG criteria (Phase 1, Phase II, and Pediatric), which refers to the percentage of patients that Reported with 95% confidence intervals. Another metric being studied is Duration of remission (DOR) (Phase I, Phase II, and Pediatric), which is defined as the time from the day CR or CRi is documented until disease progression or death. Lastly, Disease free survival"

Answered by AI

What other research studies have used Leukapheresis as a treatment method?

"Leukapheresis is the process of blood cell removal and as of now, there are 969 active clinical trials concerning this procedure. 171 of those studies are in Phase 3 while 29345 locations around the world are running these kinds of tests."

Answered by AI

Are patients still being enrolled in this study?

"At this time, researchers are not actively recruiting patients for this study. The trial was first posted on 8/11/2014 and was last updated on 4/14/2022. However, there are other studies with similar focus areas that might be enrolling patients. For example, there are 1521 trials actively searching for participants with leukemia, myeloid, acute and 969 studies for Leukapheresis actively enrolling patients."

Answered by AI

Recent research and studies

BloodJournal

Cytokine Activation Induces Human Memory-like NK Cells

Romee, Rizwan, Stephanie E. Schneider, Jeffrey W. Leong, Julie M. Chase, Catherine R. Keppel, Ryan P. Sullivan, Megan A. Cooper, and Todd A. Fehniger. 2012. “Cytokine Activation Induces Human Memory-like NK Cells”. Blood. American Society of Hematology. doi:10.1182/blood-2012-04-419283.

Proceedings of the National Academy of SciencesJournal

Cytokine-induced Memory-like Natural Killer Cells

Cooper, Megan A., Julie M. Elliott, Peter A. Keyel, Liping Yang, Javier A. Carrero, and Wayne M. Yokoyama. 2009. “Cytokine-induced Memory-like Natural Killer Cells”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.0813192106.

Journal of Experimental MedicineJournal

Sustained Effector Function of Il-12/15/18–preactivated NK Cells Against Established Tumors

Ni, Jing, Matthias Miller, Ana Stojanovic, Natalio Garbi, and Adelheid Cerwenka. 2012. “Sustained Effector Function of Il-12/15/18–preactivated NK Cells Against Established Tumors”. Journal of Experimental Medicine. Rockefeller University Press. doi:10.1084/jem.20120944.

BloodJournal