Rituxan/Bendamustine/PCI-32765 in Relapsed DLBCL, MCL, or Indolent Non-Hodgkin's Lymphoma (NCT01479842) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Rituxan/Bendamustine/PCI-32765 in Relapsed DLBCL, MCL, or Indolent Non-Hodgkin's Lymphoma
United States48 participantsStarted 2014-03-26
Plain-language summary
This phase I trial studies the side effects and best dose of BTK inhibitor PCI-32765 when given together with rituximab and bendamustine hydrochloride in treating patients with recurrent non-Hodgkin lymphoma (NHL). BTK inhibitor PCI-32765 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving BTK inhibitor PCI-32765 together with rituximab and bendamustine hydrochloride may kill more cancer cells.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* Pr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily focused on finding the safest dose of ibrutinib (PCI-32765) combined with rituximab and bendamustine, what does that mean for what's currently known about whether this combination actually works against my specific type of lymphoma?
2My lymphoma is relapsed, which means I've already been through at least one round of treatment — given that this trial is studying dose-limiting toxicities across three drugs at once, how does my doctor weigh the potential risks of this combination against standard second-line options available to me right now?
3The trial is listed as 'active, not recruiting,' which suggests they're no longer enrolling new patients — is there any way my doctor could still explore access to ibrutinib through a different trial, a compassionate use program, or a currently approved indication that might apply to my diagnosis?
4This trial covers several different lymphoma types, including my specific subtype — can my doctor explain whether the safety and early efficacy signals seen so far in this study are relevant to my particular diagnosis, or whether they mostly reflect results from patients with a different lymphoma type in the same trial?
5Bendamustine and rituximab are already used together as a standard regimen for some of these lymphomas — can my doctor help me understand what adding ibrutinib to that combination might change in terms of both the treatment burden and the side effect profile I should be prepared for?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose (MTD) as determined by the incidence of dose limiting toxicities (DLT) of BTK inhibitor PCI-32765 when given in combination with rituximab and bendamustine hydrochloride