Is NCT07661095 recruiting in Montvale, NJ?

Yes, NCT07661095 is currently recruiting participants at its Montvale, NJ location. This acute myeloid leukemia clinical trial is actively enrolling qualified participants.

How do I join the acute myeloid leukemia clinical trial in Montvale?

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

Is participation in this Montvale 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.

Acute Myeloid Leukemia Clinical Trial in Montvale, NJ

Who Can Participate

Inclusion Criteria

Documentation of Disease o Participant has relapsed or refractory acute myeloid leukemia, defined as bone marrow blasts ≥ 5%, and/or reappearance of blasts in the blood in at least 2 peripheral blood samples at least one week apart, and/or development of extramedullary disease; or, no CR, CRh or CRi at response assessment after at least 1 line of therapy, as defined by standardized European LeukemiaNet 2022 Criteria. Patients must have failed treatment with available therapies known to be active for treatment of their AML.

Participant must be ≥ 18 years of age at the time of signing the informed consent form (ICF).

Participant must weigh at least 40 kg

Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 (See Appendix I for performance status criteria)

For patients with known HIV, HBV, and/or HCV infection \[HIV, HBV, and HCV testing do not need to be performed as part of the study; the below language provides guidelines for inclusivity of patients with known HIV, HBV, and/or HCV infection\]:

HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

Required Organ Function

Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3 x ULN, unless considered due to leukemic organ involvement.

Serum total bilirubin \< 1.5 x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome.

Calculated creatinine clearance (CrCl) ≥ 60 mL/min by Cockcroft-Gault formula or CKD-EPI 2021 or estimated glomerular filtration rate 60 mL/min or greater based on local institutional practice for age-appropriate determination (e.g, Schwartz formula for pediatric patients or Cockcroft Gault formula for adults).

Adequate cardiac function defined as ejection fraction of ≥ 50% by echocardiogram.

Exclusion Criteria

Participants with acute promyelocytic leukemia

Participants with isolated myeloid sarcoma

Blast phase of chronic myeloid leukemia

Known active central nervous system leukemia

Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, disseminated intravascular coagulation, or uncontrolled tumor lysis syndrome.

Participant has presence of any other condition that may increase the risk associated with study participation, and in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.

Participants with concurrent other malignancy that will confound interpretation of study endpoints.

Participants who have received other anti-leukemia therapy within 5 half-lives of the agent or 14 days, whichever is sooner, prior to study treatment and if toxicity related to said agent has not resolved; exceptions of acceptable concomitant therapies are listed below

Concomitant cytoreductive therapy in the form of hydroxyurea, corticosteroids, or cytarabine is permitted.

Concomitant therapy in the form of intrathecal chemotherapy for CNS treatment, is permitted.

Radiation therapy is not permitted except for localized palliative radiation to focal lesions after discussion with the Medical Monitor for patients who have progressed but remain on the study due to perceived clinical benefit per Investigator assessment

Participants with active graft versus host disease (GVHD) of grade 2 or higher requiring systemic treatment. Skin GVHD solely managed with topical corticosteroids would not be exclusionary.

Known prior severe hypersensitivity to an investigational product or any component of the study drug therapy's formulations including polyethylene glycol (PEG; National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v6.0 Grade ≥ 3)

Prior organ transplantation, other than allogeneic or autologous hematopoietic stem cell transplantation.

Received a live vaccine within 30 days of the planned start of study drug. a. (Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowed.)

Evidence of clinically significant immunosuppression including the following: a. Primary immunodeficiency state such as SCID b. Concurrent opportunistic infection c. Receiving systemic immunosuppressive therapy (\>2 weeks) including oral steroid doses \> 10 mg/day of prednisone or equivalent within seven days prior to enrollment. In the setting of non-immune mediated indications for use, chronic/active low dose steroid use (equivalent to ≤ 10 mg/day prednisone) may be permitted at the discretion of the Principal Investigator i. (Note: Other steroid formulations or steroid use for other indications may be permitted and include: 1) Intranasal, inhaled, ocular, or topical steroids, or local steroid injection (e.g., intra-articular injection); 2) Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; 3) Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)

History or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past two years prior to enrollment a. (Note: Replacement therapy \[e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency\] is not considered a form of systemic treatment for autoimmune disease.)

Evidence of clinically significant interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis related to prior immunotherapy treatment

Participant has significant active cardiac disease within 6 months prior to start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and/or stroke.

Participant has QTc interval (i.e., Fridericia's correction \[QTcF\]) ≥ 470 ms. Patients with a QTcF over 470 ms due to a bundle branch block or a pacemaker may participate in the study with approval of the study principal investigator.

Participant has active viral infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)

Participant is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.

Participant has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment).

Participant with active use of strong or moderate CYP3A4 inhibitors.

Female participant who is pregnant or lactating.

Because STING agonist agents impact immune and cellular functioning posing potential risk for impacting normal embryonic development, and because other therapeutic agents used in this trial are known to be teratogenic, participants of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 6 months (females) or 3 months (males) following the completion of study therapy. Male or female participants not willing to comply with contraceptive requirements will be excluded, which adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 6 months (females) or 3 months (males) following the completion of study therapy

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 Montvale?

Yes, this clinical trial (NCT07661095) has an active research site in Montvale, NJ 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.

Acute Myeloid Leukemia Treatment Options in Montvale, NJ

If you're searching for acute myeloid leukemia treatment options in Montvale, NJ, this clinical trial (NCT07661095) 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 Montvale research site is actively enrolling participants for this clinical trial. You'll receive care from experienced 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 acute myeloid leukemia clinical trials near you to find additional studies recruiting in your area.

Acute Myeloid Leukemia Clinical Trial in Montvale, NJ

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