Is NCT06054776 recruiting in Duarte, CA?

Yes, NCT06054776 is currently recruiting participants at its Duarte, CA location. This mantle cell lymphoma clinical trial is actively enrolling qualified participants.

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

To join this clinical trial in Duarte, 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 Duarte 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 Duarte, CA

About This Mantle Cell Lymphoma Study in Duarte

This phase II trial studies the side effects of acalabrutinib, obinutuzumab, and glofitamab and how well they work together for treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Glofitamab is a class of medications called bispecific antibodies. Bispecific antibodies are designed to simultaneously bind to T cells and cancer cell antigens, leading to T-cell activation, proliferation, and cancer cell death. Giving acalabrutinib, obinutuzumab, and glofitamab together may be a safe and effective treatment for patients with relapsed or refractory mantle cell lymphoma.

Sponsor: City of Hope Medical Center

Who Can Participate

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative

Be willing to provide tissue from a fresh core or excisional biopsy (performed as standard of care) of a tumor lesion prior to starting study therapy or from diagnostic tumor biopsies

If unavailable, exceptions may be granted with study principal investigator (PI) approval

Age: \>= 18 years

Eastern Cooperative Oncology Group (ECOG) =\< 2

Histologically confirmed diagnosis of mantle cell lymphoma according to the World Health Organization (WHO) classification

Relapsed or refractory disease after at least 1 prior line of systemic therapy

Relapse must have been confirmed histologically with hematopathology review at the participating institution. Exceptions may be granted with study PI approval

Tumor must be positive for CD20 by immunohistochemistry or flow cytometry after the most recent therapy

Active disease requiring treatment per treating physician's decision

Radiographically measurable disease by Lugano criteria (e.g., one or more nodal sites of disease \>= 1.5 cm and/or extranodal sites of disease \>= 1.0 cm in longest dimension)

If measurable bone marrow involvement or circulating disease has been confirmed in the absence of radiographically measurable disease, exceptions may be granted with study PI approval

Fully recovered from the acute toxic effects (except alopecia) to =\< grade 1 to prior anti-cancer therapy

Without bone marrow involvement: Absolute neutrophil count (ANC) \>= 1,000/mm\^3 With bone marrow involvement: No minimal requirement

NOTE: Growth factor is not permitted within 7 days prior to screening unless cytopenia is secondary to disease involvement.

Without bone marrow involvement: Platelets \>= 75,000/mm\^3 With bone marrow involvement: Platelets \>= 30,000/mm\^3

NOTE: Platelet transfusions are not permitted within 7 days prior to screening unless cytopenia is secondary to disease involvement

Hemoglobin \>= 8 g/dL unless anemia is secondary to disease involvement

NOTE: Erythropoietin and/or red blood cell transfusions are not permitted within 7 days prior to screening.

Total bilirubin =\< 1.5 x upper limit of normal (ULN) (If hepatic involvement by lymphoma, or Gilbert's disease: =\< 3X ULN)

Aspartate aminotransferase (AST) =\< 2.5 x ULN (If hepatic involvement by lymphoma: AST =\< 5 x ULN)

Alanine aminotransferase (ALT) =\< 2.5 x ULN (If hepatic involvement by lymphoma: ALT =\< 5 x ULN)

Normal creatinine (Cr) level per local laboratory reference range or creatinine clearance of \>= 50mL/min per 24 hour urine test or the Cockcroft-Gault formula

If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) =\< 1.5 x ULN If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants

If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants

Left ventricular ejection fraction (LVEF) \>= 40%

Oxygen (O2) saturation \>= 92% on room air

Women of childbearing potential (WOCBP): negative urine or serum pregnancy test

NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

Agreement by females of childbearing potential\

to abstain from heterosexual intercourse or use two adequate methods of birth control, including at least one method with a failure rate of \< 1% per year, during the treatment period until at least 7 days after the final dose of acalabrutinib; at least 2 months after the final dose glofitamab; at least 18 months after the dose of obinutuzumab; and at least 4 months after the last dose of tocilizumab (as applicable). Women must refrain from donating eggs during this same period Agreement by males to abstain from heterosexual intercourse or use a condom with female partners of childbearing potential or pregnant female partners during the treatment period and for at least 2 months after the last dose of glofitamab, and at least 4 months after the last dose of obinutuzumab, or tocilizumab (as applicable) to avoid exposing the embryo. Men must refrain from donating sperm during this same period

Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) with no identified cause other than menopause

Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone releasing intrauterine devices, and copper intrauterine devices

Exclusion Criteria

Prior treatment with a T-cell engaging bispecific antibody

Prior therapeutic intervention with any of the following: therapeutic anti-cancer antibodies within 4 weeks (i.e. rituximab); radio- or toxin-immunoconjugates within 4 weeks; all other chemotherapy or radiation therapy within 2 weeks prior to day 1 of protocol therapy

Prior exposure to a BTK inhibitor (including but not limited to ibrutinib, acalabrutinib, zanubrutinib, and pirobrutinib) for more than 180 cumulative days prior to enrollment. Patients with =\< 180 cumulative days on BTK inhibitor prior to enrollment are allowed, as long as they did not progress on treatment.

Prior chimeric antigen receptor (CAR) T cell therapy within 6 months of day 1 of protocol therapy

Prior allogeneic stem cell transplant

Autologous hematopoietic stem cell transplant within 3 months of day 1 of protocol therapy

Major surgical procedure (under general anesthesia) within 30 days of day 1 of protocol therapy.

Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug

Systemic steroid therapy for any cause must be tapered down to =\< 20 mg/day prednisone or equivalent. Exceptions are:

Use of brief ( =\< 7 days) course of high dose corticosteroids (100 mg/day prednisone or equivalent) prior to initiation of study therapy for control of lymphoma-related symptoms

Inhaled or topical steroids

Use of mineralocorticoids for management of orthostatic hypotension

Use of physiologic doses of corticosteroids for management of adrenal insufficiency

Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), within 2 weeks or five half-lives (whichever is shorter) prior to first dose of study treatment

Live virus vaccines within 30 days prior to day 1 of protocol therapy or planned administration of live virus vaccines during glofitamab therapy

Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer

History of solid organ transplantation

Known history of hypersensitivity or anaphylaxis to study drug(s) including active product or excipient components, including prior monoclonal antibody therapy

Concurrent participation in another therapeutic clinical trial

History of prior malignancy. Exceptions include malignancy treated with curative intent and no known active disease present for \>= 2 years prior to initiation of protocol therapy; adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease; adequately treated in situ carcinomas (e.g., cervical, esophageal, etc.) without evidence of disease; asymptomatic prostate cancer managed with "watch and wait" strategy

Prior history of myeloid malignancies including myelodysplastic syndrome (MDS) or presence of cytogenetic and/or molecular abnormalities known to be associated with MDS or myeloproliferative neoplasms (MPN) (e.g. del 5q, chr 7 abn, JAK2 V617). Any evidence of clonal hematopoiesis in the screening bone marrow biopsy should be discussed with the study PI prior to enrollment.

Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass

Known active central nervous system (CNS) involvement by lymphoma, including leptomeningeal involvement

Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.

Note: Subjects with a history of stroke who have not experienced a cerebrovascular accident (CVA), ischemic stroke or transient ischemic attack (TIA) within the past 2 years and have no residual neurologic deficits, as judged by the investigator, are allowed

Known history of progressive multifocal leukoencephalopathy (PML)

Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)

Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening

Known bleeding disorders (e.g., von Willebrand's disease or hemophilia)

Clinically significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, any class III or IV cardiac disease as defined by the New York Heart Association (NYHA) Functional Classification, or any class C or D cardiac disease as defined by the NYHA Objective Assessment.

NOTE: Subjects with controlled, asymptomatic atrial fibrillation/flutter can enroll on study

Inability to swallow and retain an oral medication

Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 4 weeks prior to day 1 of protocol therapy

Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis

Suspected or latent tuberculosis

Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Testing to be done only in patients suspected of having infections or exposures. Patients with history of HBV infection (defined as negative hepatitis B surface antigen \[HBsAg\] and positive hepatitis B core antibody \[HBcAb\]) are eligible if HBV DNA is undetectable, if they are willing to undergo DNA testing on day 1 of every cycle and every three months for at least 12 months after the last cycle of study treatment and appropriate antiviral therapy. Patients who are positive for HCV antibody are eligible if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA) (PCR testing only required if HCV antibody testing is positive).

Known active human immunodeficiency virus (HIV) infection. Subjects who have an undetectable or unquantifiable HIV viral load with CD4 \> 200 and are on highly active antiretroviral therapy (HAART) medication are allowed. Testing to be done only in patients suspected of having infections or exposures

Females only: Pregnant or breastfeeding, or intending to become pregnant, or unable/unwilling to comply with pregnancy testing and birth control measures

Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

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 Duarte?

Yes, this clinical trial (NCT06054776) has an active research site in Duarte, CA 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 Duarte, CA

If you're searching for mantle cell lymphoma treatment options in Duarte, CA, this clinical trial (NCT06054776) 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 Duarte research site is actively enrolling participants for this phase 2 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 Duarte, CA

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