Chemo-Free combo shows promise for older CLL patients
NCT ID NCT02315768
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested a combination of two drugs, ibrutinib and obinutuzumab, in 32 older adults (65+) or those with health issues who had untreated chronic lymphocytic leukemia (CLL). The goal was to see if the combo could safely reduce cancer cells without using chemotherapy. The trial looked at side effects, dose limits, and how well the cancer responded.
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 (two drugs taken together)
- What this could lead to
- If successful, this combination could offer a chemotherapy-free treatment option for older or frail patients with chronic lymphocytic leukemia (CLL).
- What could go wrong
- This was an early-phase trial with only 32 participants, so results may not apply to everyone. Side effects from the drugs are possible, and long-term benefits are not yet proven.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
32 people
The number who actually took part.
- Started
-
Aug 2015
- Finished
-
Apr 2022
- 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
-
65 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Diagnosis of CLL 2. Indication for treatment as defined by the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) Guidelines 3. No previous treatment for CLL 4. Males and females 65 years of age and older. Subjects under 65 years of age that meet any of the following criteria: A. Documented refusal to be treated with chemotherapy agents B. Subjects that are not candidates for treatment with chemotherapy based on poor performance status (ECOG g\>= 2), Cumulative Illness Rating Scale (CIRS score) \>= 6 or creatinine clearance less than 70 mL/min 5. Adequate hematologic, hepatic, and renal function 6. Anticipated survival of at least 6 months 7. Effective contraception is required while receiving Ibrutinib in combination with GA101-Obinutuzumab. For women of childbearing potential and men, effective contraception is required while receiving GA101-Obinutuzumab and for 365 days (12 months) after the last dose of the study drug Exclusion Criteria: 1. Pregnant or nursing women 2. Treatment with chemotherapy, monoclonal antibodies, or biological agents (e.g. lenalidomide) other than the investigational agents during the time of participation in this trial 3. Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification 4. Severe or debilitating pulmonary disease 5. Participation in any investigational drug study within 28 days prior to initiation of treatment within this protocol. 6. History of second malignancy, other than non-melanoma skin cancer or in situ carcinoma of the cervix or the breast, unless the tumor was successfully treated at least 2 years before trial entry and with no evidence of relapse or active cancer. 7. Active symptomatic fungal, bacterial and/or viral infection including evidence of infection with HIV, human T-cell leukemia virus 1 (HTLV-1) seropositive status. 8. Evidence of active acute or chronic Hepatitis B (HBV) 9. Evidence of active Hepatitis C (HCV): subjects with positive hepatitis C serology and positive HCV RNA test 10. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy 11. Known hypersensitivity to any of the study drugs 12. Major surgery (within 4 weeks prior to the start of Cycle 1), except for procedures that are performed for diagnostic purposes 13. Vaccination with a live vaccine within 28 days of the initiation of treatment. 14. Concomitant use of warfarin or other Vitamin K antagonists 15. Requirement to receive treatment with a strong cytochrome P450 (CYP) 3A inhibitor 16. Chronic liver disease with hepatic impairment (Child-Pugh class B or C)
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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
-
UCSD Moores Cancer Center
La Jolla, California, 92093, 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?