Promising CLL combo trial halted early — only 5 patients enrolled
NCT ID NCT03514017
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This small Phase 2 trial tested two drugs — ibrutinib and pembrolizumab — in people with untreated high-risk chronic lymphocytic leukemia (CLL). The goal was to see if the combination could improve the body's immune function and shrink or control the cancer. However, the study was terminated early after enrolling only 5 participants, so we have very little information about how well it worked or what side effects occurred.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ibrutinib (Imbruvica) and pembrolizumab (Keytruda)
- What this could lead to
- If it worked, this combination might improve immune function and control high-risk CLL better than current treatments.
- What could go wrong
- The trial was terminated early with only 5 participants, so results are very limited. It is unclear if the combination is safe or effective, and it may not work as hoped.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
5 people
The number who actually took part.
- Started
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May 2019
- Finished
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May 2023
- 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
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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: * Have high risk CLL * Have documented previously untreated CLL according to IWCLL criteria * Willing and able to provide written informed consent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Demonstrate adequate organ function * Able to take oral medication and willing to adhere to the medication regimen Exclusion Criteria: * Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment * Meets IWCLL criteria to start therapy * Has had any treatment for CLL including any investigational agent, chemotherapy, mAb, anti-PD-1, anti-PDL-1, or anti-CTLA-4 * Transformation of CLL to aggressive NHL (Richter's transformation or pro-lymphocytic leukemia) * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 90 days after the last dose of trial treatment * Major surgery or a wound that has not fully healed within 4 weeks of first dose * Additional criteria may apply
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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
-
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, 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?