Ibrutinib and Nivolumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT02940301|
Recruitment Status : Recruiting
First Posted : October 20, 2016
Last Update Posted : April 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Classical Hodgkin Lymphoma||Drug: Ibrutinib Other: Laboratory Biomarker Analysis Biological: Nivolumab||Phase 2|
I. To estimate the complete response (CR) rate with ibrutinib at the standard dose of 560 mg daily in combination with nivolumab 3 mg/kg intravenously (IV) every 3 weeks up to 16 infusions in patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
I. To determine the overall response rate (ORR) with ibrutinib and nivolumab in combination in patients with relapsed or refractory classical HL.
II. To determine safety and toxicity of ibrutinib in combination with nivolumab in patients with relapsed or refractory cHL.
III. To determine the progression free survival (PFS) in patients with relapsed or refractory cHL treated with combined ibrutinib and nivolumab.
IV. To determine the duration of response in patients with relapsed or refractory cHL treated with ibrutinib in combination with nivolumab.
I. To determine the effects of ibrutinib and nivolumab on the distribution of T-, B-, and NK cells in the peripheral blood.
II. To determine the effects of ibrutinib and nivolumab on Th1/Th2 cytokines profile and correlate this with treatment response.
III. To determine the effects of ibrutinib and nivolumab on Th1/Th2 ration and specific IgG sub-isotypes.
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-21 and nivolumab IV continuously over 60 minutes on day 1.Treatment with nivolumab repeats every 21 days for up to 16 courses and treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Trial of Ibrutinib and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma|
|Actual Study Start Date :||December 20, 2016|
|Estimated Primary Completion Date :||May 31, 2019|
|Estimated Study Completion Date :||May 31, 2020|
Experimental: Treatment (ibrutinib, nivolumab)
Patients receive ibrutinib PO QD on days 1-21 and nivolumab IV continuously over 60 minutes on day 1. Treatment with nivolumab repeats every 21 days for up to 16 courses and treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Proportion of patients in CR [ Time Frame: Up to course 7 (147 days) ]Simon's two-stage design will be used to test the null hypothesis that the true CR rate is =< 20% versus the alternative hypothesis that the true CR rate is >= 50%.
- Duration of response [ Time Frame: From the first documentation of response (CR, partial response) to the first documentation of definitive disease progression or death from any cause, whichever occurs first, assessed up to 3 years ]Kaplan-Meier methods will be used to estimate duration of response curves and corresponding quantiles (including the median).
- Incidence of adverse events measured by Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: Up to 3 years ]Will be summarized by type and grade, including incidence of grade 3+ adverse events. Initially, adverse event data will be summarized regardless of attribution, but may also be summarized for treatment-related adverse events. Number of cycles administered and reasons for treatment discontinuation will also be summarized to assess tolerability.
- ORR [ Time Frame: Up to 3 years ]Defined as the number of patients who achieve a complete or partial remission divided by the number of evaluable patients, will be calculated with an exact 90% confidence interval.
- PFS [ Time Frame: From the date of enrollment until the first documentation of objective disease progression or death from any cause, whichever occurs first, assessed up to 3 years ]Kaplan-Meier methods will be used to estimate the PFS curves and corresponding quantiles (including the median).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940301
|Contact: Ohio State University Comprehensive Cancer Center||1-800-293-5066||Jamesline@osumc.edu|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Lapo Alinari 614-685-9256 Lapo.Alinari@osumc.edu|
|Contact: Pamela Heeter 614-293-9627 Pamela.Heeter@osumc.edu|
|Principal Investigator: Lapo Alinari|
|Principal Investigator:||Lapo Alinari||Ohio State University Comprehensive Cancer Center|