New drug combo shows promise for Hard-to-Treat blood cancer
NCT ID NCT02537613
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 1 study tests a combination of two drugs, ibrutinib and obinutuzumab, in 54 people with chronic lymphocytic leukemia (CLL) that has returned or not responded to prior treatment. The main goal is to check safety and find the best dosing schedule. Researchers will also look at how well the combination shrinks or controls the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ibrutinib and obinutuzumab
- What this could lead to
- If it works, this could offer a new treatment option for people with CLL that has come back or not responded to other therapies.
- What could go wrong
- This is a small, early-phase trial focused on safety, not proof of effectiveness. The combination may cause side effects and may not work for everyone.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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54 people
The number who actually took part.
- Started
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Dec 2015
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 criteria: * Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma as per IW-CLL 2008 criteria and require therapy based on meeting at least one of the following criteria: * Evidence of progressive marrow failure with anemia (hemoglobin \<11.0 g/L) and/or thrombocytopenia (platelets \<100 x 10\^9/L) * Massive (≥6 cm below the left costal margin), progressive, or symptomatic splenomegaly * Massive nodes (at least 10 cm longest diameter), progressive, or symptomatic lymphadenopathy * Progressive lymphocytosis with an increase of more than 50% over a 2-month period or LDT of \<6 months. * Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids * Constitutional symptoms, defined as 1 or more of the following: * unintentional weight loss \>10% within 6 months prior to screening * significant fatigue (inability to work or perform usual activities) fevers \>100.5° F or 38.0° C for 2 or more weeks prior to screening without evidence of infection * night sweats for more than 1 month prior to screening without evidence of infection * Relapsed after or refractory to at least one prior Chronic Lymphocytic Leukemia-directed therapy * Age greater than or equal to 18 years * ECOG Performance Status \<2 * Heme criteria at screening, unless significant bone marrow involvement of Chronic Lymphocytic Leukemia confirmed on biopsy: * Absolute Neutrophil Count (ANC) ≥500 cells/mm3 (0.5 x 10\^9/L). Growth factor allowed to achieve * Platelet count ≥25,000 cells/mm3 (25 x 10\^9/L) independent of transfusion within 7 days of screening * Adequate hepatic function defined as: AST and ALT ≤ 4.0 x upper limit of normal (ULN), bilirubin ≤2.0 x upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome) * Adequate renal function defined by serum creatinine \<2.0 x upper limit of normal (ULN) unless due to biopsy proven Chronic Lymphocytic Leukemia kidney infiltration * Women of child-bearing potential and men must agree to use adequate contraception * Patients who have undergone prior allo transplant are eligible provided that their transplant day 0 is \> 6 months from their first dose of study drug Exclusion Criteria: * History of severe allergic or anaphylactic reactions to monoclonal antibody therapy * Prior treatment with either obinutuzumab or ibrutinib * History of other malignancies, except: * Malignancy treated with curative intent and with no known active disease present for ≥3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician. * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. * Adequately treated carcinoma in situ without evidence of disease. * Low-risk prostate cancer on active surveillance * Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc., or chronic administration of \>20 mg/day of prednisone) within 28 days of the first dose of study drug. * Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug. * Recent infection requiring systemic treatment that was completed ≤7 days before the first dose of study drug. * Known bleeding disorders or hemophilia. * History of stroke or intracranial hemorrhage within 6 months prior to enrollment. * Known history of HIV or active hepatitis C virus (HCV) or hepatitis B virus (HBV). * Any uncontrolled active systemic infection. * Major surgery within 4 weeks of first dose of study drug. * Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 CHF as defined by the NYHA Functional Classification; or a history of Myocardial Infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization. * Lactating or pregnant. * Patients receiving any other study agents * Patients with known Central Nervous System involvement * Baseline QT Interval Corrected by the Fridericia Correction Formula (QTcF) \>480 ms unless Left Bundle Branch Block * Patients who require warfarin or other vitamin K antagonists for anticoagulation * Concurrent administration of strong inhibitors or inducers of CYP3A
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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
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Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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University of Rochester Wilmot Cancer Inst.
Rochester, New York, 14642, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo aims to push CLL into deep remission
- Can a new BTK inhibitor outsmart resistance in CLL?
- Can a new pill outsmart Drug-Resistant leukemia?
- Can engineered immune cells beat tough B-Cell cancers?
- Can a targeted drug outperform chemo for a common blood cancer?
- Can a triple drug combo outsmart High-Risk CLL?