Zanubrutinib in Combination With Odronextamab for the Treatment of Patients With Richter's Transformation
A Phase I Study of Covalent BTK Inhibitor Zanubrutinib in Combination With a CD3-CD20 Bispecific Antibody Odronextamab in Patients With Richter's Transformation
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 3 years
- Procedures mentioned: Ultrasound, Biopsies, Blood draws, CT scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Patients also undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) and optional bone marrow biopsy at screening and ultrasound guided biopsy of lymph node at screening and during days 2-12 of cycle 2."
- "Additionally, patients undergo blood sample collection and positron emission tomography (PET), or computed tomography (CT) throughout the study."
- "After completion of study treatment, patients are followed up at 4 and 12 weeks then every 6 months for up to 3 years."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This early-stage study tests zanubrutinib with odronextamab for Richter's transformation, when chronic lymphocytic leukemia (CLL) changes into a faster-growing cancer. It checks the drugs' safety, side effects, and how well they work. It is for adults whose cancer has changed into diffuse large B-cell lymphoma.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older and give informed consent, or have a legal representative give consent.
- Have confirmed Richter's transformation into diffuse large B-cell lymphoma. Cancer cells must test positive for a marker called CD20.
- Have either untreated cancer or cancer that returned or did not respond to treatment.
- Have a lymph node at least 1.5 cm wide on a scan, an enlarged spleen, or lymphoma in the bone marrow.
- Be able to care for yourself and be out of bed or a chair for at least half the day. Past cancer treatment side effects must be mild or gone, except hair loss.
- Meet study limits for blood counts, liver and kidney health, blood clotting, and heart pumping strength.
- Meet hepatitis B, hepatitis C, and HIV testing rules. People with these infections may qualify if virus levels cannot be detected; people with HIV must be on effective treatment.
- If able to have children, follow pregnancy testing and birth control rules during treatment and for at least 6 months after the last dose. Do not donate sperm during this time.
Who can't join
- Have had an organ transplant, a donor bone marrow transplant within 6 months, or active graft-versus-host disease, when donor cells attack your body.
- Have had a CD20-targeted bispecific antibody, a drug that binds two targets. Other recent cancer treatments, research drugs, live vaccines, or major surgery may also rule you out.
- Use ongoing steroid doses above the study limit, or need certain drugs that strongly change how the body handles the study drugs. Some short steroid courses are allowed.
- Have uncontrolled immune attacks that destroy red blood cells or lower platelets, which help blood clot.
- Have allergies to drugs similar to the study drugs, or to both allopurinol and rasburicase.
- Have certain serious or unstable heart problems, uncontrolled blood pressure, or a heart attack within 6 months. A stroke, mini-stroke, or blood clot within 3 months also rules you out.
- Have lung disease that causes scarring or inflammation between the air sacs, or severely reduced lung function.
- Have had cancer in the brain or spinal cord within 6 months before study treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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)
Study sites (1)
CA
- City of Hope Medical Center · Duarte, CA 91010Alexey V. Danilov · Study contact · 626-218-2405 · adanilov@coh.orgAlexey V. Danilov · Principal investigatorMore trials in Duarte