Suspended

PCI-32765, Rituximab, and Bendamustine Combination for Relapsed B-cell Non-Hodgkin's Lymphoma

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Study Aim

This study aims to determine the maximum tolerated dose of the BTK inhibitor PCI-32765 when given in combination with rituximab and bendamustine hydrochloride for the treatment of relapsed B-cell Non-Hodgkin's Lymphoma.

What is being tested

BTK inhibitor PCI-32765

+ rituximab

+ bendamustine hydrochloride

DrugBiologicalOther
Who is being recruted

Blood Protein Disorders+20

+ Cardiovascular Diseases

+ Hematologic Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: March 2014
See protocol details

Summary

Principal SponsorKami Maddocks, MD
Last updated: March 24, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 26, 2014

Actual date on which the first participant was enrolled.

This clinical trial focuses on treating patients with relapsed and refractory B-cell Non-Hodgkin's Lymphoma (NHL), a type of cancer that affects the lymphatic system. The study aims to find the right dose and understand the specific side effects of a combination therapy. This therapy includes a drug called PCI-32765, a Bruton's Tyrosine Kinase (BTK) inhibitor, used together with Rituxan (rituximab) and bendamustine. The goal is to improve treatment options for patients with this condition and address current challenges in managing relapsed and refractory B-cell NHL. During the trial, participants receive PCI-32765 orally once a day for 28 days. They also receive Rituxan intravenously (through a vein) on day one and bendamustine hydrochloride intravenously on days one and two. This cycle repeats every 28 days for up to six courses, unless the disease progresses or there are unacceptable side effects. Participants may continue taking PCI-32765 if their condition does not worsen or they do not experience severe side effects. The study measures the effectiveness of this combination therapy by looking at the response rate and the duration of response in patients. It also identifies potential markers that could predict a patient's response to the treatment.

Official TitleA Phase I, Dose-escalation Trial of Rituxan and Bendamustine in Combination With Bruton's Tyrosine Kinase Inhibitor, PCI-32765, in Patients With Relapsed Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Indolent Non-Hodgkin's Lymphoma
NCT01479842
Principal SponsorKami Maddocks, MD
Last updated: March 24, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoproliferative DisordersWaldenstrom MacroglobulinemiaNeoplasmsNeoplasms by Histologic TypeParaproteinemiasVascular DiseasesLymphoma, B-CellLymphoma, Large B-Cell, DiffuseLymphoma, B-Cell, Marginal ZoneHemostatic DisordersLymphoma, Mantle-CellNeoplasms, Plasma Cell

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive BTK inhibitor PCI-32765 PO QD on days 1-28. Patients also receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may continue receiving BTK inhibitor PCI-32765 PO in the absence of disease progression or unacceptable toxicity.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Ohio State University Medical Center

Columbus, United StatesOpen Ohio State University Medical Center in Google Maps
SuspendedOne Study Center