Atezolizumab, Obinutuzumab, and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia… (NCT02846623) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Atezolizumab, Obinutuzumab, and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Relapsed or Refractory Richter Syndrome
United States50 participantsStarted 2017-01-31
Plain-language summary
This phase II trial studies how well atezolizumab, obinutuzumab, and venetoclax work in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma or Richter syndrome that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as atezolizumab and obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as venetoclax, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving atezolizumab, obinutuzumab, and venetoclax may work better in treating patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or Richter syndrome.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients will have a diagnosis of CLL or SLL or RTand are: a) Cohort 1: Patients with treatment naïve CLL/SLL who meet IWCLL criteria for treatment or b) Cohort 2: RT (treatment-naïve or R/R)
. Age \>/= 18 years
. Eastern Cooperative Oncology Group (ECOG) Performance Status \</= 2
. Patients must have adequate renal and hepatic function: -- Serum bilirubin \</= 1.5 x upper limit of normal (ULN). For patients with Gilbert's disease, serum bilirubin up to \</= 3 x ULN is allowed provided normal direct bilirubin. -- Serum creatinine \</= 1.5 x ULN, -- Alanine aminotransferace (ALT) and aspartate aminotransferase (AST) \</= 2.5 x ULN
. Females of childbearing potential \[A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\>/=12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)\] must have a negative serum or urine beta human chorionic gonadotrophin (b-hCG) pregnancy test result within 14 days prior to the first dose of treatment and must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of \<1% per year during the treatment period and for 6 months following the last dose of the study drugs. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. #5 Continued - Males who have partners of childbearing potential must agree to use an effective contraceptive method such as a barrier method during the study and for 6 months following the last dose of study drugs. Males should also refrain from donating sperm.
. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
. Patients or their legally authorized representative must provide written informed consent
Exclusion criteria
. Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized prostate cancer. If patients have another malignancy that was diagnosed/treated within the last 2 years, such patients may be enrolled if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy at MD Anderson Cancer Center and after consultation with the Principal Investigator.
. Prior treatment with CTLA-4, PD-1, PD-L1, or CD137 mAb, or venetoclax.
. Any major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy, investigational therapy within 4 weeks prior to the first dose of the study drugs. Note: for patients on oral targeted therapies, a wash-out of 3 days from cycle 1 day 1 is acceptable.
. Adverse events from prior anticancer therapy that have not resolved to Grade \</= 1 except for alopecia
. Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 3 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
. History of stroke or cerebral hemorrhage within 3 months
. Patients who have uncontrolled hypertension (defined as sustained systolic blood pressure \>/= 160 mmHg or diastolic \>/= 100 mmHg)
. Known evidence of active cerebral/meningeal CLL. Patients may have a history of central nervous system (CNS) leukemic involvement if definitively treated with prior therapy and no evidence of active disease at the time of registration (defined as \>/= 2 consecutive spinal fluid assessments with no evidence of disease)