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Chemotherapy

Cytokine induced memory-like NK cells for Acute Myelogenous Leukemia

Phase 2
Waitlist Available
Led By Jeffrey Bednarski, M.D., Ph.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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing CIML NK cells combined with FLAG chemotherapy as a treatment for relapsed or refractory AML in children. CIML NK cells have been shown to be safe and successful in adults, and this trial will test if they are effective in children.

Eligible Conditions
  • Acute Myelogenous Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Percentage of patients able to proceed to stem cell transplant
Response rate (complete remission (CR) plus complete remission with incomplete blood count recovery (CRi))
Secondary outcome measures
Disease-free survival (DFS)
Duration of remission
Overall survival (OS)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Recipient: FLAG + CIML NK Cells + IL-2Experimental Treatment5 Interventions
-The recipient will begin a chemotherapy regimen of fludarabine, cytarabine and GCSF starting on Day -7. 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. CIML NK cells will be infused at maximum cell dose of 10 x 106/kg. 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: Donor:Experimental Treatment1 Intervention
-On Day -1 (one day before the planned NK cell infusion), peripheral blood mononuclear cells will be collected by a single standard apheresis over 4-5 hours (with a target volume of at least 20 L) from the identified haploidentical donor. The apheresis procedure will be done as per standard institutional procedures (which may include placement of a central line if necessary). If the goal minimum NK cell dose will not be met based on the initial assessment of the leukapheresis product, a second collection/procedure may be performed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Ara-C
2005
Completed Phase 4
~2510
Leukapheresis
2016
Completed Phase 2
~690
Interleukin-2
1994
Completed Phase 3
~700
G-CSF
2014
Completed Phase 4
~1610

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,709 Total Patients Enrolled
Jeffrey Bednarski, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
32 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 are the memory-like NK cells that are activated by cytokines typically used for?

"Cytokine induced memory-like NK cells is a treatment that can be used for bone marrow transplantation as well as febrile neutropenia, neutropenia, and infection."

Answered by AI

How many people are signing up to participate in this research?

"At the moment, this research is not looking for more volunteers. The listing was first published on December 31st, 2022 and has had one update on June 30th, 2022. For those still interested in participating in medical trials, there are 1522 clinical trials for leukemia patients and 727 cytokine-induced memory NK cell studies that are currently enrolling participants."

Answered by AI

Does this research include seniors in the testing process?

"Children aged 1 year old up to 21 years old may qualify for this clinical trial. Out of the 717 trials available for minors, this is one option. Alternatively, there are 1738 trials open to people over 65 years old."

Answered by AI

Are there still opportunities available to participate in this research?

"Unfortunately, this particular clinical trial is not currently enrolling new patients. The original posting date was December 31st, 2022 and the most recent update to the listing was on June 30th, 2022. If you are interested in other trials, there are 1522 studies for leukemia patients and 727 Cytokine induced memory-like NK cells that are actively recruiting participants."

Answered by AI

Has the FDA given permission for Cytokine-induced memory cells to be used in treatments?

"While Phase 2 trials don't have data supporting efficacy, Cytokine induced memory-like NK cells received a score of 2 due to the available safety data."

Answered by AI

Are there other examples in the medical literature of Cytokine-induced memory cells being used to treat patients?

"There are currently 727 active Cytokine induced memory-like NK cells trials. Of those, 97 have reached Phase 3. The vast majority of these studies are based in Saint Louis, Missouri; however, there are 15375 total locations running these sorts of trials."

Answered by AI

How can I become a participant of this experiment?

"This study is open to 48 participants that are between 1 and 21 years old that have myelocytic leukemia. To be eligible, these patients must meet the following requirements: 5% or more blasts in bone marrow (M2/M3), with or without extramedullary disease, related donor (parent, sibling, offspring or offspring of sibling), at least 18 years of age, and not pregnant."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Cytokine-induced Memory-like NK Cells in Combination With Chemotherapy in Pediatric Patents With Refractory or Relapsed AML
2023. "Cytokine-induced Memory-like NK Cells in Combination With Chemotherapy in Pediatric Patents With Refractory or Relapsed AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04354025.
~0 spots leftby Sep 2026
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