Is NCT07583810 recruiting in Duarte, CA?

Yes, NCT07583810 is currently recruiting participants at its Duarte, CA location. This conjunctival mucosa-associated lymphoid tissue lymphoma clinical trial is actively enrolling qualified participants.

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.

Conjunctival Mucosa-Associated Lymphoid Tissue Lymphoma Clinical Trial in Duarte, CA

Q: How do I join the conjunctival mucosa-associated lymphoid tissue 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.

About This Conjunctival Mucosa-Associated Lymphoid Tissue Lymphoma Study in Duarte

This phase II trial tests the effect of nemtabrutinib in combination with rituximab in treating patients with marginal zone lymphoma. Nemtabrutinib, a non-covalent Bruton's tyrosine kinase (BTK) inhibitor, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nemtabrutinib in combination with rituximab may be safe, tolerable and/or effective in treating patients with marginal zone lymphoma.

Sponsor: City of Hope Medical Center

Who Can Participate

Inclusion Criteria

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

Assent, when appropriate, will be obtained per institutional guidelines

Age: ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) ≤ 2

Diagnosis of MZL including splenic marginal zone lymphoma (SMZL), extra nodal marginal zone lymphoma (ENMZL) and nodal marginal zone lymphoma (NMZL), established by histologic assessment

Requiring treatment for MZL. Patients receiving prior systemic therapy as well as treatment naïve patients are eligible

Local radiotherapy not exceeding a total dose of 20 Gy at least 2 weeks prior the first dose of study therapy is allowed

Radiographically measurable lymphadenopathy or extra nodal lymphoid malignancy (as defined by Lugano Classification for non-Hodgkin lymphoma \[NHL\])

Subjects with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed

Subjects with skin extranodal marginal zone lymphoma (EMZL) who do not meet the radiographically measurable disease criteria described herein are eligible provided that skin lesion measures ≥ 1.5 cm in diameter and is documented by photo or there are multiple skin lesions measuring \> 1cm in diameter on the body that cannot be incorporated in one radiation field and at least one of them is histologically confirmed as MZL

Subjects with gastric extra nodal MZL histologically confirmed and need therapy but do not have measurable disease and in which response to treatment can be assess by multiple random gastric biopsies

Subjects with conjunctival EMZL who do not meet the radiographically measurable disease criteria described herein are eligible provided that conjunctival lesion measures ≥ 1 cm in diameter and is documented by photo or there are multiple conjunctival lesions measuring together \> 1 5cm that cannot be treated by radiation because of previous radiation therapy, contraindications to radiation and patient refusal to receive radiation therapy. At least one of these lesions needs be histologically confirmed as MZL

Willing to provide a lymph node or tissue biopsy from the most recent available archival tissue or undergo an incisional or excisional lymph node or tissue biopsy

Subjects with splenic MZL who do not have a tumor to biopsy or an archival tumor tissue sample are eligible provided subject is willing to undergo a bone marrow biopsy or provide an archival bone marrow biopsy that was obtained before the date of the first dose of study treatment; bone marrow sample must show histologically confirmed infiltration of MZL

At least one of the following criteria for treatment initiation:

Involvement of ≥ 3 nodal sites, each with diameter of ≥ 3 cm

Any nodal or extra nodal tumor mass with a diameter of ≥ 5 cm

B symptoms (fever ≥ 38 degrees Celsius of unclear etiology, night sweats, weight loss \> 10% within the prior 6 months) or other symptoms attributed to disease or specific organ involvement associated with the relapse

Risk of local compressive symptoms that may result in organ compromise

Splenomegaly or splenic lesion without splenomegaly

Leukopenia attributed to MZL (leukocytes \< 1000/mm\^3)

Leukemia (\> 5,000 lymphoma cells/mm\^3)

Threatened organ function, especially for extra nodal MZL

Requirement for transfusion or growth factor support attributed to lymphoma

Involvement of 2 or more extra nodal sites, with tumor/lesion in each extra nodal site ≥ 1 cm

Progression or relapsed within 24 months after MZL diagnosis in patients previously treated with ≥ 1 line of systemic therapy

Life expectancy \> 3 months

Prior adverse events (AEs) must be resolved to grade 1

Without bone marrow involvement: Absolute neutrophil count (ANC) ≥ 1,000/mm\^3

NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement

With bone marrow involvement: ANC ≥ 500/mm\^3

NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement

Without bone marrow involvement: Platelets ≥ 50,000/mm\^3

NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement.

With bone marrow involvement: Platelets ≥ 30,000/mm\^3

NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement.

Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

Subjects with documented history of Gilbert's syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible

Hemoglobin ≥ 8.0 g/dL

Aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN in the presence of liver involvement by lymphoma

Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5 x ULN in the presence of liver involvement by lymphoma

Creatinine clearance of ≥ 45 mL/min/1.73 m\^2 using the Modification of Diet in Renal Disease formula OR ≥ 45 mL/min by the Cockcroft-Gault formula

Seronegative for hepatitis C virus (HCV), hepatitis B virus (HBV) (surface antigen negative) OR

If seropositive for HBV or HCV, nucleic acid quantitation must be performed. Viral load must be undetectable. Patients with occult or prior HBV infection (defined as negative hepatitis B virus surface antigen \[HBsAg\] and positive hepatitis B core antibody \[HBcAb\]) may be included if HBV deoxyribonucleic acid (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

Participants with HIV are eligible if they meet ALL the following:

CD4 count \> 350 cells/µL at screening

The HIV viral load is below the detectable level as per locally available testing

Are on a stable antiretroviral therapy (ART) regimen for at least 4 weeks prior to study entry

NOTE: ART includes drugs, which are NOT strong cytochrome P450 (CYP)3A4 inducers (participants receiving ART that are strong CYP3A4 inducers are not eligible to be included in the study)

HIV screening tests are not required unless:

Known history of HIV infection

As mandated by local health authority

Are compliant with their ART

NOTE: If the participant has had an AIDS defining opportunistic infection in the past 12 months prior to screening, they are not eligible to be included in the study

Person of childbearing potential (POCBP): Negative urine or serum pregnancy test

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

Participants assigned male sex at birth:

If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:

Nemtabrutinib: 12 days

Rituximab: 3 months

Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR

Uses contraception as detailed below unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview) as detailed below:

Uses a penile/external condom plus nonparticipant of childbearing potential who is not currently pregnant and should also be advised of the benefit for that partner to use an additional method of contraception, as a condom may break or leak

Note: Participants capable of producing ejaculate whose partner is pregnant or breastfeeding must agree to use penile/external condom during each episode of sexual activity in which the partner is at risk of drug exposure via ejaculate

Contraceptive use by participants capable of producing sperm should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed

Participants assigned female sex at birth:

A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:

Is not a person of childbearing potential (POCBP) OR

Is a POCBP and:

Uses a contraceptive method that is highly effective (with a failure rate of \< 1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:

Nemtabrutinib: 1 month

Rituximab: 12 months

The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.

Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for urine test) or 72 hours (for serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive

Abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention with nemtabrutinib

Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy

Patients with gastrointestinal dysfunction and/or clinically significant medical condition of malabsorption, inflammatory bowel disease, chronic conditions which manifest with diarrhea, refractory nausea, vomiting or any other condition that will interfere significantly with drug absorption (e.g., gastric bypass surgery, gastrectomy)

Exclusion Criteria

Evidence of diffuse large B-cell lymphoma (DLBCL) transformation

Subjects with presumptive evidence of transformation based on clinical assessment of factors such as, but not limited to, increasing lactate dehydrogenase, rapidly worsening disease, or frequent B-symptoms, must be ruled out for a transformation to a more aggressive disease, such as DLBCL

History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease

Active graft versus host disease

Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization)

Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment

Receipt of anticancer medications or investigational drugs within the following intervals before the date of the first dose of study treatment:

\< 10 weeks from completion of any radio- or toxin-immunoconjugates

\< 4 weeks for immunotherapy

\< 3 weeks for radiotherapy

\< 2 weeks for any investigational agent or other anticancer medications

Steroids that are used for treatment of allergy or other underlying condition are permittable, but not steroids started to treat lymphoma. Subjects receiving corticosteroids must be at a dose level ≤ 10 mg/day within 7 days of the study treatment administration

Inadequate recovery from adverse events related to prior therapy to grade ≤ 1 (excluding grade 2 alopecia and neuropathy)

Prior non-covalent BTK inhibitor (prior covalent BTK inhibitors are allowed)

Major surgery (under general anesthesia) within 30 days prior to therapy initiation

Live vaccine within 30 days

Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 2 weeks of the first day of study therapy

History of prior malignancy except:

Malignancy treated with curative intent and no known active disease present for ≥ 2 years prior to initiation of 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

Superficial bladder cancer

Myelodysplastic syndrome which is clinically well controlled and no evidence of the cytogenetic abnormalities characteristic of myelodysplasia on the bone marrow at screening

History of severe bleeding disorder defined as an ongoing congenital or acquired condition that leads to an increased likelihood of bleeding

Unstable cardiac disease as defined by one of the following:

Acute myocardial infarction (MI) within the past 6 months

NYHA (New York Heart Association) heart failure class III

Unstable angina (angina symptoms at rest) or new-onset angina (begun within the last 3 months)

Left ventricular ejection fraction (LVEF) \< 45%

Corrected QT interval (QTc) prolongation (defined as a Fridericia's formula-corrected QT interval \[QTcF\] \> 450 msecs) or other significant electrocardiogram (ECG) abnormalities including second degree atrioventricular (AV) block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats/min)

AIDS-defining opportunistic infection in the past 12 months prior to screening

History or concurrent condition of interstitial lung disease and/or severely impaired lung function

Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before the start of study treatment

History of organ transplant

Known allergy/sensitivity to nemtabrutinib or any of the excipients; history of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents

Clinically significant uncontrolled illness

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 the first study treatment

Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma

POCBP: Pregnant or breastfeeding

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 (NCT07583810) 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.

Conjunctival Mucosa-Associated Lymphoid Tissue Lymphoma Treatment Options in Duarte, CA

If you're searching for conjunctival mucosa-associated lymphoid tissue lymphoma treatment options in Duarte, CA, this clinical trial (NCT07583810) 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 conjunctival mucosa-associated lymphoid tissue 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 conjunctival mucosa-associated lymphoid tissue lymphoma clinical trials near you to find additional studies recruiting in your area.

Conjunctival Mucosa-Associated Lymphoid Tissue Lymphoma Clinical Trial in Duarte, CA

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