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Chemotherapy

Cytokine-induced Memory-like NK Cells in Combination With Chemotherapy in Pediatric Patents With Refractory or Relapsed AML

Saint Louis, MO

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

No Placebo-Only Group

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.

See full description

Eligible Conditions

Acute Myelogenous Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response rate (complete remission (CR) plus complete remission with incomplete blood count recovery (CRi))

Secondary study objectives

Disease-free survival (DFS)

Overall survival (OS)

Safety of regimen as measured by number of adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

G-CSF

2014

Completed Phase 4

~1610

Interleukin-2

1994

Completed Phase 3

~990