Ibrutinib in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02824029|
Recruitment Status : Active, not recruiting
First Posted : July 6, 2016
Last Update Posted : June 28, 2022
|Condition or disease||Intervention/treatment||Phase|
|Classical Hodgkin Lymphoma Recurrent Hodgkin Lymphoma Refractory Hodgkin Lymphoma||Drug: Ibrutinib Other: Laboratory Biomarker Analysis Other: Pharmacological Study||Phase 2|
I. To determine the antitumor efficacy of single agent ibrutinib as measured by the overall response rate in patients with relapsed/refractory Hodgkin's lymphoma who have relapsed or not responded to chemotherapy, immunotherapy and/or radiation.
I. To assess duration of tumor control including duration of response (DOR) II. To assess progression free survival (PFS). III. To assess the safety and tolerability of 560mg of ibrutinib in Hodgkin lymphoma (HL) patients.
I. To assess the mechanism(s) by which ibrutinib may be active in patients with classical Hodgkin lymphoma (cHL) by the correlation of potential biomarkers with clinical outcomes.
Patients receive ibrutinib orally (PO) once daily (QD). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days then every 9 weeks for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Multicenter Single Arm Study to Evaluate the Efficacy and Safety of Single Agent Bruton's Tyrosine Kinase Inhibitor, Ibrutinib, in Patients With Relapsed Refractory Classical Hodgkin's Lymphoma|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
Experimental: Treatment (ibrutinib)
Patients receive ibrutinib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- Overall response rate (ORR) defined as the proportion of participants having a complete (CR) and partial (PR) response [ Time Frame: From date of study entry to date of progression or death up to 24 months ]A one-sample binomial test will be used to assess ORR.
- Duration of response (DOR) [ Time Frame: From date of documented tumor response, CR or PR, to date of disease progression,up to 24 months ]DOR will be reported as median and range.
- Progression free survival (PFS) [ Time Frame: From date of study entry to date of progression or death. ]Kaplan-Meier estimate of median PFS will be reported with 95% confidence intervals.
- Incidence of Treatment-Emergent adverse Events (safety and tolerability) [ Time Frame: From date of study entry to date of progression or death up to 24 months. ]Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
- Identify which genes and immune alterations are affected by ibrutinib. [ Time Frame: From date of study entry until completion of testing up to 24 months ]analysis of tumor and blood samples for gene expression, mutation analysis, and immune alterations.
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): NCT02824029
|United States, Michigan|
|University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109|
|Wayne State University/Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, Tennessee|
|University of Tennessee|
|Knoxville, Tennessee, United States, 37920|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Erlene Seymour, M.D.||Barbara Ann Karmanos Cancer Institute|