Is NCT06735664 recruiting in Duarte, CA?

Yes, NCT06735664 is currently recruiting participants at its Duarte, CA location. This recurrent transformed chronic lymphocytic leukemia 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.

Recurrent Transformed Chronic Lymphocytic Leukemia Clinical Trial in Duarte, CA

Q: How do I join the recurrent transformed chronic lymphocytic leukemia 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 Recurrent Transformed Chronic Lymphocytic Leukemia Study in Duarte

This phase I trial tests the safety and side effects of zanubrutinib in combination with odronextamab and how well it works in treating patients with Richter's transformation. Zanubrutinib, a tyrosine kinase inhibitor, blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. Odronextamab is a bispecific monoclonal antibody that can bind to two different antigens at the same time. Odronextamab binds to CD20 found on B-cells (a type of white blood cell) and on many B-cell cancers and to CD3 on T-cells (also a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Giving zanubrutinib in combination with odronextamab may be safe, tolerable and/or effective in treating patients with Richter's transformation.

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

Histologically confirmed diagnosis of Richter transformation (RT; transformed CLL). Only patients who have diffuse large B-cell lymphoma histology in transformation are eligible (for example, patients with transformation into Hodgkin lymphoma subtype are not eligible)

Evidence of CD20 positivity at screening (by immunohistochemistry \[IHC\] or flow cytometry)

Treatment naïve or relapsed/ refractory disease. Patients with either previously untreated RT and previously treated RT are eligible, regardless of whether or not they had received CLL-directed therapy

Radiographically measurable lymphadenopathy (≥ 1.5 cm) or splenomegaly, or bone marrow involvement by diffuse large B cell lymphoma (DLBCL)/RT

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

NOTE: A participant may not have received granulocyte colony stimulating factor (G-CSF) within 3 days of first dose of the assigned study treatment in order to meet this eligibility requirement

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

NOTE: A participant may not have received granulocyte colony stimulating factor (G-CSF) within 3 days of first dose of the assigned study treatment in order to meet this eligibility requirement

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

NOTE: A participant may not have received platelet transfusion within 7 days of first dose of the assigned study treatment in order to meet this eligibility requirements

With bone marrow involvement: Platelets ≥ 25,000/mm\^3

NOTE: A participant may not have received platelet transfusion within 7 days of first dose of the assigned study treatment in order to meet this eligibility requirements

With bone marrow involvement: Hemoglobin (Hgb) ≥ 7 g/dL

Total bilirubin ≤ 2 x upper limit of normal (ULN) or ≤ 3 x ULN for Gilbert's disease or compensated hemolysis directly attributable to CLL

Aspartate aminotransferase (AST) ≤ 3 x ULN

Alanine aminotransferase (ALT) ≤ 3 x ULN

Alkaline phosphatase (ALP) ≤ 2.5 x ULN or ≤ 5 x ULN if attributed to lymphoma involvement of the liver

Serum creatinine ≤ 1.5 x ULN OR creatinine clearance of ≥ 50 mL/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) ≥ 45%

Note: To be performed within 28 days prior to day 1 of protocol therapy

Seronegative for hepatitis C virus (HCV), hepatitis B virus (HBV) (surface antigen negative) and no history of HIV OR

If seropositive for HBV or HCV, nucleic acid quantitation must be performed. Viral load must be undetectable

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

Women of childbearing potential (WOCBP): Negative serum pregnancy test

Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of study therapy. Sperm donation is prohibited during the study and for 6 months after the last dose of the assigned study treatment. Highly effective contraceptive measures include:

Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated ≥ 2 menstrual cycles prior to screening

Intrauterine device (IUD); intrauterine hormone-releasing system (IUS)

Bilateral tubal ligation/occlusion

Vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the study patient and that the partner has obtained medical assessment of surgical success for the procedure)

Sexual abstinence, only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs

Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to the clinical trial facilitation group guidance. Pregnancy testing and contraception are not required

Exclusion Criteria

Allogeneic bone marrow or organ transplant within 6 months or evidence of active graft versus host diseae (GVHD)

Prior CD20-targeted bispecific antibody therapy

Chronic systemic corticosteroid use \> 10 mg/day of prednisone or equivalent within 72 hours (h) of start of study treatment. Patients who received corticosteroid treatment with ≤ 10 mg/day of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration prior to day 1 of cycle 1. Patients may have received a brief (≤ 10 days) course of systemic steroids (≤ 80 mg prednisone equivalent per day) up to 24 hours prior to initiation of study therapy for control of lymphoma-related symptoms

Therapeutic anticancer antibodies within 2 weeks prior to day 1 of protocol therapy

Radio- or toxin-immunoconjugates within 10 weeks prior to day 1 of protocol therapy

Live vaccine within 28 days prior to day 1 of protocol therapy

Any investigational therapy within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment

Standard radiotherapy within 14 days of first administration of study treatment

Prior organ transplantation

Chemotherapy, within 2 weeks prior to day 1 of protocol therapy; targeted therapy within 6 half-lives or two weeks, whichever is shorter

Requires treatment with a strong CYP3A4 inducers/ inhibitor while on protocol therapy

Uncontrolled immune hemolysis or thrombocytopenia

History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drug

Known hypersensitivity to both allopurinol and rasburicase

Unstable cardiac disease as defined by one of the following:

Cardiac events such as myocardial infarction (MI) within the past 6 months

NYHA (New York Heart Association) heart failure class III-IV

Uncontrolled atrial fibrillation or hypertension

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

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

Active uncontrolled cardiac arrythmia

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

Evidence of central nervous system (CNS) involvement within 6 months prior to initiation of study therapy

Major surgery (under general anesthesia) within 30 days prior to day 1 of protocol therapy

Clinically significant uncontrolled illness

Evidence of any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other) at study enrollment or within 2 weeks of study enrollment, if requiring ongoing treatment and/or has the potential to cause disseminated disease or severe infection upon immunosuppression. There should be evidence that the infection has cleared or is well controlled by start of study therapy

Active COVID-19 infection

Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)

NOTE: Participants with HIV who have controlled infection (undetectable viral load and CD4 count above 350 cells/uL either spontaneously or on a stable antiviral regimen) are permitted

NOTE: Participants who are hepatitis B surface antigen positive or who are hepatitis B core antibody positive should undergo evaluation by a specialist and be considered to have controlled infection (serum hepatitis B virus deoxyribonucleic acid \[DNA\] polymerase chain reaction \[PCR\] that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) before they are permitted onto study

NOTE: Participants who are HCV antibody positive who have controlled infection (undetectable HCV ribonucleic acid \[RNA\] by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted

Cytomegalovirus (CMV) infection as noted by detectable levels on peripheral blood polymerase chain reaction (PCR) assay. Patients who show detectable levels of CMV at screening will need to be treated with appropriate antiviral therapy and demonstrate at least 2 undetectable levels of CMV by PCR assay (at least 7 days apart) before being re-considered for eligibility

Other active malignancy. Patients with a prior (in the past 5 years) 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. History of the following is allowed:

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

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

Females only: Pregnant or breastfeeding

Inability to swallow and retain oral medication

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 (NCT06735664) 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.

Recurrent Transformed Chronic Lymphocytic Leukemia Treatment Options in Duarte, CA

If you're searching for recurrent transformed chronic lymphocytic leukemia treatment options in Duarte, CA, this clinical trial (NCT06735664) 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 1 clinical trial. You'll receive care from experienced recurrent transformed chronic lymphocytic 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 recurrent transformed chronic lymphocytic leukemia clinical trials near you to find additional studies recruiting in your area.

Recurrent Transformed Chronic Lymphocytic Leukemia Clinical Trial in Duarte, CA

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