Blood markers may predict ibrutinib success in tough leukemia
NCT ID NCT02827617
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study followed 56 people with a high-risk form of chronic lymphocytic leukemia (CLL) who were taking the drug ibrutinib. Researchers looked for changes in the blood that could show early on whether the drug was working or failing. The goal is to find simple markers that help doctors make better treatment decisions for this hard-to-treat 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
- What this could lead to
- If successful, this could help doctors identify early which patients benefit from ibrutinib and which might need a different treatment.
- What could go wrong
- This is a small, observational study that does not test a new treatment. The findings may not change practice without larger trials.
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.
- Participants
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About 56 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2016
- Finished
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May 2024
- 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.
Who is studied
Adult CLL patients harboring TP53 genetic abnormalities, independent of whether treatment naïve or previously treated, who warrants treatment according to iwCLL 2008 criteria, and who is planned to receive ibrutinib at standard dose as per clinical practice
- 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.
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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: * Male or female adults 18 years or older * Documented diagnosis of CLL, according to iwCLL 2008 criteria * Presence of TP53 mutation as demonstrated by sequencing at the local laboratory and/or presence of 17p deletion as demonstrated by fluorescence in situ hybridization (FISH) testing performed at the local laboratory * CLL that warrants treatment * Planned treatment with ibrutinib 420 mg quaque die * Willing and able to comply with scheduled visits, laboratory tests, and study procedures * Evidence of a signed informed consent Exclusion Criteria: * Current or prior histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation). * Prior treatment with ibrutinib or idelalisib
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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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Clinica Ematologica, Centro Trapianti e Terapie Cellulari "Carlo Melzi"
Udine, 33100, Italy
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Clinica Luganese Moncucco
Lugano, 6903, Switzerland
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Department of Haematology, Tor Vergata Hospital
Rome, 00133, Italy
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Department of Medical and Surgical Sciences, section of Hematology
Modena, 41124, Italy
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Dipartimento di Ematologia, Niguarda Cancer Center, Ospedale Niguarda
Milan, 20133, Italy
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Division of Hematology, Department of Internal Medicine, Basel University Hospital
Basel, 4031, Switzerland
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Divisione di Ematologia, Universita' del Piemonte Orientale
Novara, 28100, Italy
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Ematologia, Ospedale di Circolo e Fondazione Macchi
Varese, 21100, Italy
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Hematology, Luzern Kantonsspital
Lucerne, 6000, Switzerland
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Institute of Hematology, Catholic University S. Cuore
Roma, 00168, Italy
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Onco Ematologia Clinico Sperimentale, I.R.C.C.S. Centro di Riferimento Oncologico
Aviano, 33081, Italy
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Oncology Institute of Southern Switzerland
Bellinzona, Switzerland, 6500, Switzerland
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Ospedale San Raffaele
Milan, 20132, Italy
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?