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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
Must not have
Prior allogeneic transplant
Active extramedullary disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if giving special immune cells from a donor to children and young adults with high-risk AML can help their immune system fight cancer and infections better after a bone marrow transplant.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a transplant from a donor.
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My cancer has spread outside the bone marrow.
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I am currently fighting a serious infection that hasn't improved with treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
1-year RFS
Secondary study objectives
Cumulative incidence of neutrophil engraftment
Cumulative incidence of platelet engraftment
Graft-vs-Host Disease
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
All subjects will receive NK infusions.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Acute Myeloid Leukemia (AML) include chemotherapy agents such as daunorubicin and cytarabine, which work by damaging the DNA of rapidly dividing cells, leading to cell death. This is crucial for reducing the number of leukemia cells in the body.
Additionally, innovative therapies like ex-vivo expanded HLA-haploidentical donor natural killer (NK) cells are being studied. These NK cells are designed to enhance immune reconstitution, decrease relapse rates, and reduce infectious complications without increasing the risk of graft-versus-host disease (GVHD).
This matters for AML patients as it offers a potential for improved survival rates and quality of life by targeting leukemia cells more effectively while minimizing adverse effects.
Clinical grade production of IL-15 stimulated NK cells for early infusion in adult AML patients undergoing haploidentical stem cell transplantation with post-transplant cyclophosphamide.Natural killer cells in acute myeloid leukemia patients: from phenotype to transcriptomic analysis.Natural killer cells generated from cord blood hematopoietic progenitor cells efficiently target bone marrow-residing human leukemia cells in NOD/SCID/IL2Rg(null) mice.
Clinical grade production of IL-15 stimulated NK cells for early infusion in adult AML patients undergoing haploidentical stem cell transplantation with post-transplant cyclophosphamide.Natural killer cells in acute myeloid leukemia patients: from phenotype to transcriptomic analysis.Natural killer cells generated from cord blood hematopoietic progenitor cells efficiently target bone marrow-residing human leukemia cells in NOD/SCID/IL2Rg(null) mice.
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
245 Previous Clinical Trials
5,073,076 Total Patients Enrolled
Nationwide Children's HospitalOTHER
348 Previous Clinical Trials
5,228,502 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a transplant from a donor.You have either Fanconi Anemia or Down syndrome.My cancer has spread outside the bone marrow.My white blood cell count is healthy following my last chemotherapy.I am currently fighting a serious infection that hasn't improved with treatment.I am 25 years old or younger.My AML is high-risk based on specific genetic mutations or because I still have cancer cells after initial treatment.I can take care of myself but may not be able to do active work.My AML is due to a specific inherited bone marrow failure, not Fanconi Anemia, and needs approval.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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