Is NCT06561360 recruiting in Montvale, NJ?

Yes, NCT06561360 is currently recruiting participants at its Montvale, NJ location. This hairy cell leukemia clinical trial is actively enrolling qualified participants.

How do I join the hairy cell 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.

Hairy Cell Leukemia Clinical Trial in Montvale, NJ

About This Hairy Cell Leukemia Study in Montvale

The researchers are doing this study to compare the safety of vemurafenib in combination with obinutuzumab to the standard of approach of cladribine in combination with rituximab. The researchers will look at which treatment causes fewer or milder side effects. Researchers think vemurafenib and obinutuzumab (non-chemotherapy drugs) may cause fewer side effects compared with the usual approach of chemotherapy drugs. They will also compare the two approaches to see which approach is more effective

Sponsor: Memorial Sloan Kettering Cancer Center

Who Can Participate

Inclusion Criteria

Patients must be ≥ 18 years of age

Histologically confirmed classical HCL by the enrolling institution

Presence of BRAF V600E mutation as confirmed by PCR, NGS or immunohistochemistry. If patient is known to have negative BRAF mutation, repeat testing is advisable as well as discussion with the main study principal investigator.

Has not received any prior therapy for the disease

Patients who meet the standard treatment initiation criteria, as defined by ANC ≤1.0, Hgb ≤ 10.0 or PLT ≤100K

ECOG performance status of 0 - 2

Acceptable pre-study organ function during screening as defined as:

Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), except in patients with known Gilbert's syndrome who may be enrolled if direct bilirubin ≤ 3 x ULN);

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN; and

Serum creatinine ≤ 1.5x ULN

Electrocardiogram (ECG) without evidence of clinically significant ventricular arrhythmias or ischemia as determined by the investigator and a rate-corrected QT interval (QTc, Bazett's formula) of \< 480 msec

For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 6 months after discontinuation of vemurafenib and cladribine, and 18 months after discontinuation of rituximab and obinutuzumab

For men with female partners of childbearing potential, agreement to use a latex condom and to advise their female partner to use an additional method of contraception during the study and for 6 months after discontinuation of vemurafenib

Negative serum pregnancy test within 7 days of commencement of treatment in women of childbearing potential

Exclusion Criteria

Have had previous treatment for HCL, including purine analogs, vemurafenib, rituximab, obinutuzumab, and other investigational agents. Previous treatment with transfusions and other supportive care such as G-CSF and erythropoietin are allowed.

Known hypersensitivity to any of the study drugs.

Patients with known long QT syndrome or uncorrectable electrolyte abnormalities

Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.

Presence of positive test results for hepatitis B virus (HBV), hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibody ° Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody \[HBcAb\] and negative HBsAg) may be included if HBV DNA is undetectable. These patients must be willing to undergo monthly DNA testing and take HBV viral prophylaxis such as entecavir.

Known infection with HIV or human T-cell leukemia virus 1 (HTLV-1)

Active uncontrolled infection, e.g. persistent bacteremia, supplemental oxygen or pressor supports, etc.

Live vaccination within 28 days of randomization

Patients with concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of the skin, in situ cervical cancer, adequately treated stage I/II cancer from which the patient is current in complete remission, or any other cancer from which the patient has been disease free for five years

Malabsorption syndrome or other condition that precludes enteral route of administration

Patients with HCL variant (as defined by absence of expression of CD25)

Pregnant or lactating, or intending to become pregnant during the study

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 (NCT06561360) 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.

Hairy Cell Leukemia Treatment Options in Montvale, NJ

If you're searching for hairy cell leukemia treatment options in Montvale, NJ, this clinical trial (NCT06561360) 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 phase 2 clinical trial. You'll receive care from experienced hairy 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 hairy cell leukemia clinical trials near you to find additional studies recruiting in your area.

Hairy Cell Leukemia Clinical Trial in Montvale, NJ

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