Is NCT05976763 recruiting in Fairfield, CT?

Yes, NCT05976763 is currently recruiting participants at its Fairfield, CT location. This mantle cell lymphoma clinical trial is actively enrolling qualified participants.

How do I join the mantle cell lymphoma clinical trial in Fairfield?

To join this clinical trial in Fairfield, 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 Fairfield 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.

Mantle Cell Lymphoma Clinical Trial in Fairfield, CT

About This Mantle Cell Lymphoma Study in Fairfield

This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. When zanubrutinib is used

Sponsor: Alliance for Clinical Trials in Oncology

Who Can Participate

Inclusion Criteria

• Histologically confirmed mantle cell lymphoma with cyclin D1 (BCL1) expression by immunohistochemical stains and/or evidence of CCND1 rearrangement or t(11;14)(q13;q32) as confirmed by the enrolling center (such as by fluorescence in situ hybridization \[FISH\], polymerase chain reaction \[PCR\]/sequencing, karyotype). Patients with cyclin D1 and/or t(11;14) negative mantle cell lymphoma with an expression profile suggesting a diagnosis of mantle cell lymphoma \[MCL\] such as SOX11 expression are also eligible

Any stage allowed (stage I-IV)

Patient must have at least one objective measurable disease parameter by PET or CT. Measurable disease in the liver is required if the liver is the only site of lymphoma OR bone marrow involvement by MCL

Steroids for management of mantle cell lymphoma are allowed up to a dose of prednisone 100mg/day (or equivalent) for up to 7 days prior to registration

No prior systemic treatment for mantle cell lymphoma

No prior radiation treatment for stage I MCL

No prior exposure to a BTK inhibitor or anti-CD20 monoclonal antibody

No prior stem cell transplant

Age \>= 70 years OR age \>= 60 to \< 70 years with comorbidities precluding autologous stem cell transplantation (autoSCT) including at least one of the following: a) cardiac ejection fraction (EF) \<= 45%, b) diffusing capacity for carbon monoxide \<= 60% predicted; c) creatinine clearance \< 70 but \>= 30ml/minute (min); d) Eastern Cooperative Oncology Group (ECOG) performance status of 2, which poses an unacceptable risk of toxicity for high-dose therapy and stem cell transplantation; or e) Cumulative Illness Rating Scales (CIRS) total score \> 6

ECOG Performance Status 0-2

Absolute neutrophil count (ANC) \>= 750/mm\^3 (without growth factor support within 7 days)

Platelet count \>= 75,000/mm\^3 (or \>= 50,000/mm\^3 if thrombocytopenia is due to lymphoma) without growth factor support or transfusion within 7 days

Creatinine clearance \>= 30 mL/ min determined by either: a) Estimation using the Cockcroft-Gault equation or b) Measurement by nuclear medicine scan or 24 hour urine collection

Total bilirubin =\< 1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome)

Aspartate transferase (AST) / alanine transaminase (ALT) =\< 3 x ULN

Patients should not be considered candidates for stem cell transplant or must have declined a stem cell transplant strategy

No clinically significant cardiovascular disease including the following

Unstable angina within 3 months before registration

New York Heart Association class III or IV congestive heart failure

History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)

Known QT correction formula (QTcF) \> 480 msecs based on Fredericia's formula (unless pacemaker in place)

History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place

Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

No active Hepatitis B or Hepatitis C infection. Patients with prior hepatitis B virus (HBV) exposure (positive HBV core antibody and/or surface antigen) are eligible if they have no detectable viral load, and are taking appropriate prophylactic antiviral therapy to prevent reactivation. Patients with history of hepatitis C virus (HCV) are eligible if they have an undetectable HCV viral load

Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

No history of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention

No history of stroke or intracranial hemorrhage within 6 months prior to registration

No disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. Patient must be able to swallow pills

Potential trial participants should have recovered from major surgery

No vaccination with a live vaccine within 35 days prior to registration

No hypersensitivity to zanubrutinib or rituximab or any of the other ingredients of the study drugs

Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study.

Patients on strong CYP3A4 inducers must discontinue the drug 14 days prior to registration.

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 Fairfield?

Yes, this clinical trial (NCT05976763) has an active research site in Fairfield, CT 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.

Mantle Cell Lymphoma Treatment Options in Fairfield, CT

If you're searching for mantle cell lymphoma treatment options in Fairfield, CT, this clinical trial (NCT05976763) 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 Fairfield research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced mantle cell lymphoma 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 mantle cell lymphoma clinical trials near you to find additional studies recruiting in your area.

Mantle Cell Lymphoma Clinical Trial in Fairfield, CT

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