Ibrutinib in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (NCT02824029) | Clinical Trial Compass
CompletedPhase 2
Ibrutinib in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
United States28 participantsStarted 2016-06
Plain-language summary
This phase II trial evaluates how effective 560 mg of ibrutinib taken by mouth daily is in the treatment of classical Hodgkin lymphoma which recurs or does not respond to initial treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth, by altering the environment around the tumor or by affecting the immune system.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria
* Patients with relapsed or refractory classical HL who have previously received autologous stem cell transplant and/or allogeneic stem cell transplant. Patients must have received prior autologous stem cell transplant at least 12 weeks (3 months) before the first dose of ibrutinib and/or allogeneic stem cell transplant must have been completed at least 6 months prior to the first dose of Ibrutinib. OR
* Patients with relapsed or refractory HL who have failed at least 2 lines of prior therapy and are not eligible for autologous stem cell transplant due to:
* Inability to achieve a CR or PR prior to transplant
* Age or comorbid conditions
* Inability to collect stem cells
* Completion of any prior treatment with radiation, chemotherapy, biologics, and/or other investigational agents at least 4 weeks prior to the first dose of ibrutinib. Patients must have completed any prior immunotherapy (e.g., rituximab or PD-1 inhibition) or antibody drug conjugate therapy (e.g. brentuximab vedotin) at least 4 weeks prior to the first dose of ibrutinib in the absence of clear disease progression.
* Prior treatment with at least 2 lines of therapy for HL including brentuximab vedotin. In those patients who cannot receive brentuximab vedotin, treatment with 2 prior therapeutic regimens is sufficient.
* Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm in minimum dimension by CT scan with contrast, as assessed by the site radiolog…
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: From date of study entry to date of progression or death up to 24 months