New combo therapy shows promise for Tough-to-Treat lymphomas
NCT ID NCT01479842
First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times
Summary
This early-stage trial tests a new three-drug combination (ibrutinib, rituximab, and bendamustine) in adults with certain types of non-Hodgkin lymphoma that have come back after prior treatment. The main goal is to find the safest dose of ibrutinib when given with the other two drugs and to check for side effects. About 48 participants will receive the treatment to see if this approach can better control the cancer.
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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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48 people
The number who actually took part.
- Started
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Mar 2014
- Expected to finish
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Dec 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
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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: * Histologically confirmed B-cell NHL of the following subtypes: follicular, marginal zone (nodal, splenic, or extranodal), Waldenstrom's macroglobulinemia, diffuse large B-cell (DLCL) or mantle cell lymphoma (MCL) according to 2008 World Health Organization (WHO) criteria that is relapsed or refractory after at least 1 prior therapy * Patients with DLCL must be relapsed or refractory after previous autologous stem cell transplant unless transplant is contraindicated * Patients with MCL, follicular lymphoma (FL), marginal zone lymphoma, or Waldenstrom's macroglobulinemia are eligible after \>= 1 prior therapies; however, patients with MCL who are not eligible for stem cell transplant (due to age or other co-morbidities) or refuse up-front stem cell transplantation may receive study treatment as their first-line therapy * Body weight \>= 40 kg * Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Agreement 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 * Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty * Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations) Exclusion Criteria: * Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease free for at least 2 years or which will not limit survival to \< 2 years (Note: these cases must be discussed with the Principal Investigator) * A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the patient'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 * 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 * Any immunotherapy, chemotherapy, radiotherapy, or experimental therapy within 3 weeks before first dose of study drug (corticosteroids for disease-related symptoms allowed but require 1-week washout before study drug administration) * Use of medications known to prolong QTc interval or that may be associated with Torsades de Pointes are prohibited within 7 days of starting study drug and during treatment * Central nervous system (CNS) involvement by lymphoma * Grade \>= 2 toxicity (other than alopecia) related to prior anticancer therapy including radiation * Known history of human immunodeficiency virus (HIV), active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV surface antigen positive), carriers of HBV (surface antigen and surface antibody negative, but HBV core antibody positive), or any uncontrolled active systemic infection * Major surgery within 4 weeks before first dose of study drug * Previous serious infusion reactions or hypersensitivity to rituximab or bendamustine not controlled or prevented by steroid pre-medication * Creatinine \> 2.0 mg/dL * Total bilirubin \> 1.5 x upper limit of normal (ULN) (unless due to Gilbert's disease) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 x ULN * Absolute neutrophil count (ANC) \< 1000/mm\^3 * Platelets \< 50,000/mm\^3 * Lactating or pregnant
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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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