New drug ibrutinib shows promise for Hard-to-Treat blood cancers
NCT ID NCT01589302
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tests the drug ibrutinib in 154 people with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or B-cell prolymphocytic leukemia (B-PLL). Participants take ibrutinib pills daily for 28-day cycles. The main goal is to see how many patients are alive and cancer-free at two years. The study also tracks overall response rates and safety.
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 show that ibrutinib helps control advanced CLL, SLL, or B-PLL for at least two years in patients who have not responded to prior treatments.
- What could go wrong
- This is a single-institution Phase 2 trial, not a large randomized study. Results may not apply to all patients, and side effects like bleeding, infection, or heart rhythm issues are possible.
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
-
154 people
The number who actually took part.
- Started
-
May 2012
- Expected to finish
-
Oct 2026
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
-
18 years and older
- Sex
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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 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: * Confirmed diagnosis of relapsed/refractory CLL/SLL who require treatment and have failed at least one prior therapy. * Patients must have available results of interphase cytogenetics CLL fluorescent in situ hybridization (FISH) panel; the cytogenetic analysis must be done prior to starting therapy but after any recent therapy * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Life expectancy greater than 2 months * Bilirubin =\< 1.5 X the institutional upper limit of normal unless due to Gilbert's disease or disease related to Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 2.5 X the institutional upper limit of normal unless disease related * Creatinine =\< 1.5 X the institutional upper limit of normal unless disease related * Absolute neutrophil count (ANC) \>= 0.75 X 10\^9/L * Platelet count \>= 30 X 10\^9/L * Agree to use contraception during the study and for 30 days after the last dose of study drug if sexually active and able to bear children * Ability to understand and the willingness to sign a written informed consent document * Patients with uncontrolled or active infection requiring antibiotic therapy; patients with controlled infections who are receiving extended antibiotics or prophylactic therapy are not excluded Exclusion Criteria: * Patients who have had chemotherapy, radiotherapy or immunotherapy within 4 weeks prior to the first dose of study drug (corticosteroids for disease-related symptoms allowed but doses equivalent to \> 20 mg prednisone orally per day require 1 week washout before study drug administration or steroid dose must be equal to =\< 20 mg prednisone orally daily) * Patients who have not recovered from adverse events of \>= grade 3 toxicity due to agents administered more than 4 weeks ago * Receiving any other investigational agents * Previously randomized to any PCI-32765 clinical trial * Known secondary malignancy that limits survival to less than two years * Patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction * Patients requiring anti-coagulation with warfarin or other Vitamin K antagonists or heparin products including low molecular weight heparin (LMWH) * Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification * Patients requiring treatment with a strong cytochrome P450 3A4/5 (CYP3A4/5) and/or cytochrome P450 2D6 (CYP2D6) inhibitor * Patients with a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk * Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification * Active central nervous system (CNS) involvement by lymphoma * Pregnant or women who are breastfeeding
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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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Ohio State University Medical Center
Columbus, Ohio, 43210, United States
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Other studies related to the condition(s) this trial covers.
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