Ibrutinib and Nivolumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (NCT02940301) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ibrutinib and Nivolumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
United States18 participantsStarted 2016-12-20
Plain-language summary
This phase II trial studies how well ibrutinib and nivolumab work in treating patients with classical Hodgkin lymphoma that has come back or has not responded to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells. Giving ibrutinib and nivolumab may work better in treating patients with classical Hodgkin lymphoma.
Who can participate
Age range
19 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:
* Patients with histologically confirmed classical HL that is relapsed or refractory after at least one prior therapy are eligible
* Patients with lymphocyte predominant Hodgkin's are eligible
* Prior treatments: patients must have had at least one prior therapy
* Patients with previous autologous transplant are permitted
* Patients who are eligible and willing to undergo autologous transplant should not be enrolled on this trial
* Prior allogeneic transplant is NOT permitted
* Prior treatment with Bruton's tyrosine kinase (BTK) inhibitors is NOT permitted
* Prior treatment with nivolumab is permitted
* Presence of radiographically measurable disease (defined as the presence of a \>= 1.0 cm lesion, as measured in the longest dimension by computed tomography \[CT\] scan or positron emission tomography \[PET\]/CT scan or magnetic resonance imaging \[MRI\] scan)
* Absolute neutrophil count (ANC) \> 1000/uL
* Platelets \> 75,000/uL
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2 x upper limit of normal (ULN)
* Total bilirubin =\< 1.5 x ULN
* Creatinine =\< 2.0 mg/dl
* Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
* Patients with human immunodeficiency virus (HIV) are not permitted to enroll
* Patients with history of hepatitis B or C infection are not permitted to enroll; to enroll patients must have no evidence of hepatitis B or C surface antigen (Ag) and negative hepatitis B core antibody (Ab…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Proportion of patients in CR
Timeframe: Up to course 7 (147 days)
Trial details
NCT IDNCT02940301
SponsorOhio State University Comprehensive Cancer Center