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Triple-Drug attack aims to wipe out Hard-to-Treat leukemia

NCT ID NCT02846623

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This phase 2 trial tests a combination of three drugs—atezolizumab, obinutuzumab, and venetoclax—in 50 adults with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma, or Richter syndrome that has returned or not responded to prior treatment. The goal is to see if the combo can reduce cancer cells to undetectable levels (MRD-negative). The study is active but no longer recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Atezolizumab, obinutuzumab, and venetoclax
What this could lead to
If successful, this combination could offer a new treatment option for people with hard-to-treat CLL or Richter syndrome, potentially achieving deep remission with no detectable cancer cells.
What could go wrong
This is a small, early-phase trial (50 people) without a comparison group. The drug combo may cause serious side effects, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

50 people

The number who actually took part.

Started

Jan 2017

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion: 1. 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) 2. Age \>/= 18 years 3. Eastern Cooperative Oncology Group (ECOG) Performance Status \</= 2 4. 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 5. 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. 6. #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. 7. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen 8. Patients or their legally authorized representative must provide written informed consent Exclusion: 1. 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. 2. Prior treatment with CTLA-4, PD-1, PD-L1, or CD137 mAb, or venetoclax. 3. 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. 4. Adverse events from prior anticancer therapy that have not resolved to Grade \</= 1 except for alopecia 5. 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 6. History of stroke or cerebral hemorrhage within 3 months 7. Patients who have uncontrolled hypertension (defined as sustained systolic blood pressure \>/= 160 mmHg or diastolic \>/= 100 mmHg) 8. 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) 9. Active, uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring steroid therapy (\>10mg/day of prednisone or equivalent). 10. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis), with the following exceptions: Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met: 11. #10 Continued: a. Rash must cover \< 10% of body surface area b. Disease is well controlled at baseline and requires only low-potency topical corticosteroids c. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months. 12. Patients with organ allografts (such as renal transplant) are excluded 13. Patients who are on high-dose steroids (doses \>10mg/day of prednisone or equivalent) or immune suppression medications. NOTE: Patients on high-dose steroids (doses \>10mg/day of prednisone or equivalent) or immune suppression medications are eligible provided these drugs are discontinued at least 3 days prior to starting on the study drugs 14. Patients with uncontrolled active infection (viral, bacterial, and fungal) are not eligible 15. History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted. 16. Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease 17. Current or chronic hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV) 18. Patient is pregnant or breast-feeding or intending to become pregnant during the course of the study or within 6 months after the last dose of the study drugs. 19. Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies or fusion proteins. 20. Patients may not receive other concurrent investigational agent, chemotherapy, radiotherapy, or immunotherapy for CLL. NOTE: Localized radiotherapy to an area not compromising bone marrow function does not apply 21. Received strong CYP3A inhibitors or strong CYP3A inducers within 7 days of starting venetoclax 22. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during the course of the study or within 5 months after the last dose of atezolizumab. 23. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.