Is NCT06017258 recruiting in Harrison, NY?

Yes, NCT06017258 is currently recruiting participants at its Harrison, NY location. This refractory acute myeloid leukemia clinical trial is actively enrolling qualified participants.

Is participation in this Harrison 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.

Refractory Acute Myeloid Leukemia Clinical Trial in Harrison, NY

Q: How do I join the refractory acute myeloid leukemia clinical trial in Harrison?

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

Who Can Participate

Inclusion Criteria

Subject Inclusion: Collection of T cells (Part A)

History of CD371+ AML

Any disease status is eligible for collection

Expression of CD371 at any level on AML blasts (any method of detection including IHC and/or flow cytometry)

Pediatrics: ≥ 1 year and ≥ 10kg for collection

Adults: no limit on age/weight for collection

Patients with history of allo-HCT are eligible for collection if:

≥ 100 days post-transplant

no evidence of active GVHD

off any immunosuppressive agents for 30 days prior to collection (physiologic dose of corticosteroids is acceptable) Subject Inclusion: Treatment with CD371-specific/YSNVz/IL-18 CAR T cells (Part B)

Relapsed/Refractory CD371+ AML (meeting criteria defined below) for primary refractory AML, late first relapse, and/or advanced disease: o Primary refractory AML: Patients are eligible from disease perspective in the event of failure to achieve a CR, CRh or CRi after one or more of the following regimens:

Two or more courses of standard intensive induction chemotherapy (e.g., cytarabine and daunorubicin given as "7+3," MEC, HiDAC, FLAG+idarubicin, etc.);

Two or more cycles of venetoclax in combination with one of the following (azacitidine OR decitabine OR low-dose cytarabine), with or without other agents;

Six or more cycles of azacitidine monotherapy OR four or more courses of decitabine monotherapy

Early first relapse: Patients are eligible from disease perspective in the event of first morphologic relapse or new extramedullary disease less than 12 months after previously having achieved CR, CRh, or CRi following AML-directed therapy

Late first relapse: Patients with first morphologic relapse or new extramedullary disease ≥12 months after previously having achieved CR, CRh, or CRi following AML-directed therapy may respond to intensive re-induction using the initial induction regimen and not eligible from a disease perspective unless the treating investigator feels the patient is unlikely to benefit from repeating the initial induction regimen (for example, relapse occurring 12 months into CR on continuous azacitidine/venetoclax therapy), in which case the rationale for considering enrollment must be clearly documented and risks, benefits, and alternatives discussed with the patient.

Advanced disease: Patients are eligible from disease perspective in the event of relapsed AML refractory to reinduction therapy, relapse following alloHCT, or second or later relapse.

Disease eligibility considerations for all patients: Patients with relapsed or refractory AML with susceptible mutations for which there is an FDA approved therapy (for example, IDH1 mutation, ivosidenib; IDH2 mutation, enasidenib; FLT3-ITD/TKD, gilteritinib) are not eligible from a disease perspective unless they meet one or more of the below criteria:

Failure to achieve CR, CRh, or CRi following therapy with one or more targeted therapies for relapsed or refractory AML directed to the actionable mutation(s);

Intolerance of one or more targeted therapies for relapsed or refractory AML directed to the actionable mutation(s);

Treating investigator feels the patient would be unlikely to benefit from FDA-approved targeted therapy based on disease characteristics, in which case the rationale for considering enrollment must be clearly documented and risks, benefits, and alternatives discussed with the patient Age: any age is eligible for treatment if eligible for collection o The first 3 patients in the first dose cohort must be ≥ 16 years of age, while the first 2 patients in subsequent cohorts must be ≥ 16 years of age (see Section 10.4)

Adequate performance status:

Age ≥ 16 years: ECOG ≤ 1 or Karnosfsky ≥ 60

Age \< 16 years: Lansky ≥ 60

Patients with history of allo-HCT are eligible for treatment if:

≥ 100 days post-transplant

no evidence of active GVHD

off any systemic immunosuppressive agents for 30 days prior to treatment (physiologic dose of corticosteroids is acceptable)

Treating physician considers the patient to be a candidate for second alloHCT

Identification of a suitable donor/source for alloHCT as determined by the treating physician.

Adequate organ function is required, defined as follows:

Hepatic: Serum total bilirubin ≤ 1.5 mg/dL, unless benign congenital hyperbilirubinemia or unless thought to be disease related.

Hepatic: ALT and AST \< 3 times the upper limit of normal unless thought to be disease-related.

Renal: serum creatinine \< 2.0 mg/100 ml (\> 18 years) or ≤ 2.5 x institutional upper limit of normal (ULN) for age

If serum creatinine is outside the normal range, then CrCl \> 40 mL/min/1.73m2 (calculated or estimated) or GFR (mL/min/1.73m2) \> 40% of predicted normal for age. Normal GFR by Age Age: 1 week / Mean GFR +/-SD (mL/min/1.73 m2): 40.6 + / - 14.8 Age: 2 - 8 weeks / Mean GFR +/-SD (mL/min/1.73 m2): 65.8 + / - 24.8 Age: \> 8 weeks / Mean GFR +/-SD (mL/min/1.73 m2): 95.7 +/- 21.7 Age: 2 - 12 years / Mean GFR +/-SD (mL/min/1.73 m2): 133 +/- 27 Age: 13 - 21 years (males) / Mean GFR +/-SD (mL/min/1.73 m2): 140 +/- 30 Age: 13 - 21 years (females) / Mean GFR +/-SD (mL/min/1.73 m2): 126.0 + / - 22.0 Abbreviations: GFR, glomerular f filtration rate; SD, standard deviation

Greater than 2 years old: Normal GFR is 100 mL/min/1.73m2.

Infants: GFR must be corrected for body surface area.

Cardiac: LVEF ≥ 50% by MUGA or resting echocardiogram.

Pulmonary: Adequate pulmonary function as assessed by ≥ 92% oxygen saturation on room air by pulse oximetry

Exclusion Criteria

Subject Exclusion: Collection of T cells (Part A)

Pregnant or lactating women; women of childbearing age, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception while receiving study treatment and for at least 12 months after all treatment is finished

Sexually active males, unless they are willing to use a condom during intercourse while receiving study treatment and for at least 12 months after all treatment is finished

Radiographically-detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥ 5/ul WBC in CSF). Subjects with adequately treated CNS leukemia are eligible.

Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject

Impaired cardiac function (LVEF \< 50%) as assessed by ECHO or MUGA scan

Patients with following cardiac conditions will be excluded:

New York Heart Association (NYHA) stage III or IV congestive heart failure

Myocardial infarction ≤ 6 months prior to enrollment

History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration

Positive serologic test results for HIV

Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+.

Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR

Patient/parent/LAR unable to give informed consent/ Subject Exclusion: Treatment with CD371-specific/YSNVz/IL-18 CAR T cells (Part B)

Bridging chemotherapy occurring \< 1 week prior to administration of LDC o Exception: hydroxyurea can be continued up to 72 hours prior to leukapheresis or 24 hours prior to LDC

Pregnant or lactating women

Radiographically-detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥ 5/ul WBC in CSF). Subjects with adequately treated CNS leukemia are eligible.

Isolated extramedullary disease

Lack of a suitable donor/source for allogeneic HSCT as determined by the treating physician.

Patients with prior alloHCT are allowed as long as alloHCT occurred ≥100 days prior to date of treatment with CD371-specific/YSNVz/IL-18 CAR T cells and as long as the patient is without ongoing requirement for systemic graft-versus-host therapy

Impaired cardiac function (LVEF \< 50%) as assessed by ECHO or MUGA scan.

Patients with following cardiac conditions will be excluded:

New York Heart Association (NYHA) stage III or IV congestive heart failure

Myocardial infarction ≤ 6 months prior to enrollment

History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration

Positive serologic test results for HIV.

Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+.

Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR

Active second malignancy that requires systemic treatments, with the exception of malignancy treated with curative intent and without evidence of disease for \> 2 years before screening

Patient/parent/LAR unable to give informed consent

Any other condition/issue which, in the opinion of the treating physician, would make the patient ineligible for the study; conditions that in the Principal Investigator's opinion might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.

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 Harrison?

Yes, this clinical trial (NCT06017258) has an active research site in Harrison, NY 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.

Refractory Acute Myeloid Leukemia Treatment Options in Harrison, NY

If you're searching for refractory acute myeloid leukemia treatment options in Harrison, NY, this clinical trial (NCT06017258) 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 Harrison research site is actively enrolling participants for this clinical trial. You'll receive care from experienced refractory 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 refractory acute myeloid leukemia clinical trials near you to find additional studies recruiting in your area.

Refractory Acute Myeloid Leukemia Clinical Trial in Harrison, NY

Expert Care in Harrison

IRB Approved

No-Cost Care

Apply for This Harrison Location

Why Participate?

Simple Process

About This Refractory Acute Myeloid Leukemia Study in Harrison