Is NCT06698003 recruiting in Commack, NY?

Yes, NCT06698003 is currently recruiting participants at its Commack, NY location. This adult t-cell leukemia clinical trial is actively enrolling qualified participants.

How do I join the adult t-cell leukemia clinical trial in Commack?

To join this clinical trial in Commack, 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 Commack 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.

Adult T-cell Leukemia Clinical Trial in Commack, NY

About This Adult T-cell Leukemia Study in Commack

The purpose of this study is to find out whether the study drug mogamulizumab is effective in preventing the development of adult T-cell leukemia/lymphoma (ATL) in people who are at higher risk for this type of cancer because they are infected with the HTLV-1 virus and because of changes seen in some of their immune system cells called T-cells.

Sponsor: Memorial Sloan Kettering Cancer Center

Who Can Participate

Inclusion Criteria

Screening Cohort (US patients only):

Age ≥18 years when informed consent is obtained

Has freely given written informed consent to participate in the study Treatment Cohorts (Cohorts 1 and 2):

Positive for anti-HTLV-1 antibody in the serum using an FDA approved assay for US patients (Avioq HTLV-I/II Microelisa System). UK patients should use UK Accreditation Service (UKAS) accredited tests, Abbot Architect ELISA Serology Screening assay and confirmatory serology Western Blot (performed at Public Health England, Virus Ref Dept, Colindale).

High-risk phenotype (PVL≥8% of PBMC)

Age ≥18 years when informed consent is obtained

Primary organ functions are stable

Neutrophil count: ≥ 1000/mm3, unless patient has diagnosis of ethnic neutropenia

Platelets: ≥100,000/mm3

Hemoglobin: ≥9.0 g/dL

Serum aspartate aminotransferase (AST): ≤1.5x upper limit of normal (ULN)

Alanine aminotransferase (ALT): ≤1.5x ULN

Total bilirubin: ≤1.5x ULN

Serum creatinine (Cr): ≤1.5x ULN

Blood oxygen saturation (SpO2): ≥90%

Electrocardiogram (ECG): No abnormal findings requiring treatment are observed

Has freely given written informed consent to participate in the study

For females of reproductive potential: use of effective contraception during treatment and for at least 3 months after completion of mogamulizumab therapy. For males who have sexual intercourse with females of reproductive potential: use of effective contraception during treatment and for at least 3 months after completion of mogamulizumab therapy.

Exclusion Criteria

In order to protect subjects and avoid any problems in evaluating the study drug, patients who meet any of the following criteria should be excluded from enrollment in the study, in either screening or treatment cohorts:

Patients with a history of any of the following:

Neutrophil count: ≤1000/mm3, unless patient has diagnosis of ethnic neutropenia

Acute or chronic hepatitis or hepatic cirrhosis, other than patients with positive antibodies and negative PCR as noted in criteria #11 and #12 below.

Tuberculosis or with active tuberculosis

Myocardial infarction within 12 months prior to the date of enrollment

Allergic reaction to administration of antibody drug products

Other cancers. Patients with a history of a localized solid tumor who received definitive, curative treatment and who have been without evidence of disease for 5 years prior to enrollment will be able to enroll in the study. Patients with radically resected basal cell carcinoma of the skin, squamous cell carcinoma (except malignant melanoma), noninvasive cervix carcinoma, carcinoma in situ in the gastrointestinal tract or corpus of the uterus, localized thyroid cancer, and localized renal cell carcinoma will be able to enroll in the study if they are determined to be completely cured, even if within 5 years of enrollment.

Prior treatment with immunosuppressants or interferon alpha products within 6 months prior to the date of enrollment

Serious complications (heart failure, lung disease, renal failure, hepatic failure, uncontrolled diabetes mellitus, etc.)

History of an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.

Any ailment that could be exacerbated by the administration of KW-0761, in the judgment of the Principal Investigator or co-Investigator

Diagnosis of ATL

Women who are pregnant, breastfeeding, who may be pregnant, or wish to bear children while receiving treatment or within 3 months of last dose of mogamulizumab

Patients who have taken multivitamins (Alinamin, vitamin C, etc.) or supplements such as fucoidan, catechin, and pentosan polysulfate within 2 weeks prior to the date of enrollment

Prior treatment with other study drugs within 4 months prior to giving informed consent

Complications of spinal cord compressive lesions such as cervical spine disease, disc herniation, and ossification of the yellow ligament

Uncontrolled psychiatric disorder, epilepsy, or dementia

Positive test for Hepatitis B surface antigen or HBV-DNA (using real-time PCR). Positive Hepatitis B core antibody is permitted if HBV-DNA PCR is negative and the patient remains on prophylaxis during study.

Positive test for Hepatitis C virus antibody, unless Hepatitis C PCR is negative.

Positive test for HIV antibody, unless undetectable HIV RNA \> 6 months and CD4 within normal limits per institutional standard.

Patients considered unqualified to participate in the study by the Principal Investigator or co-Investigator

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 Commack?

Yes, this clinical trial (NCT06698003) has an active research site in Commack, 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.

Adult T-cell Leukemia Treatment Options in Commack, NY

If you're searching for adult t-cell leukemia treatment options in Commack, NY, this clinical trial (NCT06698003) 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 Commack research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced adult t-cell 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 adult t-cell leukemia clinical trials near you to find additional studies recruiting in your area.

Adult T-cell Leukemia Clinical Trial in Commack, NY

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