Is NCT06609928 recruiting in Seattle, WA?

Yes, NCT06609928 is currently recruiting participants at its Seattle, WA location. This recurrent childhood acute myeloid leukemia clinical trial is actively enrolling qualified participants.

Is participation in this Seattle clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Recurrent Childhood Acute Myeloid Leukemia Clinical Trial in Seattle, WA

Q: How do I join the recurrent childhood acute myeloid leukemia clinical trial in Seattle?

To join this clinical trial in Seattle, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Recurrent Childhood Acute Myeloid Leukemia Study in Seattle

This phase I trial tests the safety, side effects, and best dose of FH-FOLR1 chimeric antigen receptor (CAR) T cells in treating pediatric patients with FOLR1+ acute myeloid leukemia (AML) that has come back after a period of improvement (recurrent) or has not responded to previous treatment (refractory). CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a FOLR1 on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Chemotherapy drugs, such as fludarabine and cyclophosphamide, are given to a patient before the manufactured FH-FOLR1 CAR T cells are infused back into the patient to assist in the CAR T cell activity in the patient. The trial is evaluating if giving FH-FOLR1 CAR T cell therapy is safe and tolerable for pediatric patients with recurrent or refractory AML.

Sponsor: Fred Hutchinson Cancer Center

Who Can Participate

Inclusion Criteria

Subject age ≤ 6 years.

Weight ≥ 7 kilograms.

AML that expresses FOLR1 by flow cytometry as assessed by Hematologics, Inc. Laboratory and meets one of the below definitions:

For subjects who have previously received an allogeneic hematopoietic cell transplantation (HCT), any evidence of AML re-emergence post HCT detectable by flow cytometry.

First relapse of AML ≤ 6 months from initial diagnosis.

First relapse of AML \> 6 months from initial diagnosis with minimal residual disease (MRD) ≥ 0.05% by flow cytometry after at least one re-induction attempt (one cycle of therapy).

Second or greater relapse of AML.

Refractory AML, defined as ≥ 0.1% leukemic cells determined by flow cytometry or \> 1% on biopsy after 2 cycles of chemotherapy.

Able to tolerate apheresis.

Life expectancy ≥ 8 weeks.

Has an appropriate stem cell donor source identified.

Lansky performance status score of ≥ 50. Subjects who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for purposes of assessing performance status.

The subject must discontinue all anticancer agents and radiotherapy and, in the opinion of the investigator, have fully recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy:

Chemotherapy and biologic agents: All chemotherapy and biologic therapy not specifically mentioned below must be discontinued ≥ 14 days prior to enrollment, with the exception of intrathecal chemotherapy for which there is not a required washout period.

Steroid use: All corticosteroid therapy (unless physiologic replacement dosing) must be discontinued ≥ 7 days prior to enrollment, unless being used to treat graft-versus-host disease (GVHD) (if being used to treat GVHD see requirements).

Tyrosine kinase inhibitor (TKI) use: All TKIs must be discontinued ≥ 3 days prior to enrollment.

Hydroxyurea: must be discontinued ≥ 1 day prior to enrollment.

FOLR1 targeting therapy must be discontinued within 30 days prior to enrollment.

Gene modified cellular therapy:

Must be at least 30 days from most recent gene modified cell therapy infusion and document no evidence of modified cells in the peripheral blood OR

Must be at least 60 days from most recent gene modified cell therapy.

Serum creatinine ≤ 1.5 x the upper limit of normal (ULN) based on the following:

Age 1 to \< 2 years: maximum serum creatinine 0.6 mg/dL for male and 0.6 mg/dL for female.

Age 2 to \< 6 years: maximum serum creatinine 0.8 mg/dL for male and 0.8 mg/dL for female.

Age 6 to \< 10 years: maximum serum creatinine 1 mg/dL for male and 1 mg/dL for female.

Total bilirubin ≤ 3 times ULN for age OR conjugated bilirubin ≤ 2 mg/dL.

Alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase \[SGPT\]) ≤ 5 times ULN.

Shortening fraction ≥ 28% OR ejection fraction (EF) ≥ 50% as measured by echocardiogram.

Oxygen saturation ≥ 92% on room air without supplemental oxygen or mechanical ventilation.

Absolute lymphocyte count (ALC) ≥ 100 cells/uL.

Virology testing negative within 3 months prior to enrollment, to include:

HIV antigen \& antibody.

Hepatitis B surface antigen.

Hepatitis C antibody OR if positive, hepatitis C polymerase chain reaction (PCR) is negative.

Subject and/or legally authorized representative has signed the informed consent form for this study.

Exclusion Criteria

Active malignancy other than acute myeloid leukemia.

History of symptomatic non-AML central nervous system (CNS) disease or ongoing symptomatic CNS disease requiring medical intervention, including paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder (subjects with non-febrile seizure disorder controlled on anti-epileptic medication and without seizure activity within 1 month are eligible).

CNS AML involvement that is symptomatic and in the opinion of the investigator, cannot be controlled during the interval between enrollment and T cell infusion.

If history of allogeneic stem cell transplant: active GVHD or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment.

If history of allogeneic stem cell transplant and patient has received donor lymphocyte infusion (DLI) the subject is \< 8 weeks from DLI infusion.

Presence of active severe infection, defined as:

Positive blood culture within 48 hours of enrollment, OR

Fever above 38.2 degrees Celsius (C), AND clinical signs of infection within 48 hours of enrollment.

Primary immunodeficiency syndrome.

Subject has received prior virotherapy.

Subject and/or legally authorized representative unwilling to provide consent/assent for participation in the 15-year follow-up period, required if FH-FOLR1 CAR T cell therapy is administered.

Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol.

Considered by the investigator to be unable to tolerate a lymphodepleting regimen.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Seattle?

Yes, this clinical trial (NCT06609928) has an active research site in Seattle, WA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Recurrent Childhood Acute Myeloid Leukemia Treatment Options in Seattle, WA

If you're searching for recurrent childhood acute myeloid leukemia treatment options in Seattle, WA, this clinical trial (NCT06609928) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Seattle research site is actively enrolling participants for this clinical trial. You'll receive care from experienced recurrent childhood acute myeloid leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all recurrent childhood acute myeloid leukemia clinical trials near you to find additional studies recruiting in your area.

Recurrent Childhood Acute Myeloid Leukemia Clinical Trial in Seattle, WA

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