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NK Cell Infusions for Acute Myeloid Leukemia (EXCEL Trial)

Phase 2

Waitlist Available

Research Sponsored by Michael Pulsipher, MD

Eligibility Criteria Checklist

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

Must have

Adequate major organ system function as demonstrated by: Renal: Creatinine clearance (CrCl) ≥60 mL/min/1.73m2 by Cockcroft-Gault formula, Schwartz formula, or nuclear GFR study (Table 3) Hepatic: Total bilirubin <2 mg/dL (unless due to Gilbert syndrome) and ALT and AST < 5x ULN Cardiac: LVEF at rest ≥50% or SF ≥27% (by MUGA or ECHO) Pulmonary: DLCO, FEV1, and FVC ≥ 50% of predicted corrected for hemoglobin. For patients <7 years of age or those unable to perform PFTs: O2 Sat >92% on room air by pulse oximetry and on no supplemental O2 at rest

Recovery from prior cycle of chemotherapy as defined by an absolute neutrophil count ≥ 500/mm3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

EXCEL Trial Summary

This trial is testing whether NK cell infusions can help kids and young adults with high-risk leukemia who are undergoing HLA-haploidentical hematopoietic cell transplants. The hope is that the NK cells will help with immune reconstitution and decrease relapse rates and infection complications.

Who is the study for?

This trial is for children and young adults up to 25 years old with high-risk acute myeloid leukemia (AML) who are undergoing a specific bone marrow transplant. They must have certain genetic mutations or minimal residual disease, be recovering from chemotherapy, and have good performance status and organ function. Those with Fanconi Anemia, Down syndrome, active extramedullary disease, serious infections, or prior transplants cannot join.Check my eligibility

What is being tested?

The study tests the effect of three doses of donor-derived natural killer cell infusions on patients with high-risk AML receiving a special bone marrow transplant. The goal is to see if these infusions help rebuild the immune system, lower relapse rates without increasing graft versus host disease (GVHD), leading to better survival rates.See study design

What are the potential side effects?

Potential side effects may include reactions related to infusion such as fever or chills; increased risk of GVHD where the body attacks the new cells; possible infection risks due to immune suppression; and typical transplantation complications.

EXCEL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My white blood cell count is healthy following my last chemotherapy.

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I am 25 years old or younger.

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I can take care of myself but may not be able to do active work.

EXCEL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

1-year RFS

Secondary outcome measures

Cumulative incidence of neutrophil engraftment

Cumulative incidence of platelet engraftment

Graft-vs-Host Disease

+3 more

EXCEL Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

All subjects will receive NK infusions.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Michael Pulsipher, MDLead Sponsor

4 Previous Clinical Trials

214 Total Patients Enrolled

Children's Hospital Los AngelesLead Sponsor

232 Previous Clinical Trials

5,076,738 Total Patients Enrolled

Nationwide Children's HospitalOTHER

341 Previous Clinical Trials

5,220,473 Total Patients Enrolled

Media Library

Treatment Arm Clinical Trial Eligibility Overview. Trial Name: NCT04836390 — Phase 2

Acute Myeloid Leukemia Research Study Groups: Treatment Arm

Acute Myeloid Leukemia Clinical Trial 2023: Treatment Arm Highlights & Side Effects. Trial Name: NCT04836390 — Phase 2

Treatment Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT04836390 — Phase 2

Frequently Asked Questions

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

Does the age of 70 or above disqualify someone from participating in this trial?

"The requirements for participation in this trial restrict enrollment to individuals between infancy and 25 years old. There are 450 trials available for minors under 18, while those over 65 have access to 1,231 such initiatives."

Answered by AI

Am I eligible to become a participant in this experiment?

"This medical trial is searching for 30 youth between the ages of 0 and 25 with acute myeloid leukemia. Eligibility criteria encompass age, performance status, presence of high-risk mutations (outlined in Appendix A), as well as a minimum remission state attained after initial induction chemotherapy."

Answered by AI

Is the trial currently recruiting participants?

"Per clinicaltrials.gov, this trial is no longer recruiting. Having been first posted on August 24th 2021 and last updated on November 1st 2021, the study has yet to begin its enrollment phase. However, 1534 other trials are presently sourcing for volunteers."

Answered by AI

Are Haploidentical IL-21-Expanded Natural Killer Cells a viable form of treatment with minimal risks?

"According to our team at Power, Haploidentical IL-21-Expanded Natural Killer Cells can be considered relatively safe with a score of 2. This is because some evidence exists which suggests it's safety, but no data has been collected to back up its efficacy yet as the trial is only in Phase 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Donor-Derived Ex-Vivo Expanded Natural Killer Cell Infusions in Children and Young Adults With High Risk Acute Myeloid Leukemia Receiving Myeloablative HLA-Haploidentical Hematopoietic Cell Transplant

Michael Pulsipher, MD 2021. "Donor-Derived Ex-Vivo Expanded Natural Killer Cell Infusions in Children and Young Adults With High Risk Acute Myeloid Leukemia Receiving Myeloablative HLA-Haploidentical Hematopoietic Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04836390.