Ibrutinib and Brentuximab Vedotin in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT02744612|
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : April 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Hodgkin Lymphoma Refractory Hodgkin Lymphoma||Drug: Brentuximab Vedotin Drug: Ibrutinib||Phase 2|
I. Evaluate the anti-tumor activity of the two agent combination ibrutinib and brentuximab vedotin, as assessed by complete response (CR) rate.
I. Assess the safety and tolerability of the two agent combination through evaluation of toxicities, including type, frequency, severity, attribution, time course and duration.
II. Obtain estimates of overall response rate (ORR), response duration and survival (overall and progression-free).
III. Describe outcomes of patients who ultimately undergo autologous or allogeneic hematopoietic cell transplantation following treatment with ibrutinib/brentuximab vedotin.
I. Collect deoxyribonucleic acid (DNA)/ribonucleic acid (RNA) from lymphoma specimens and serial plasma samples for future biomarker evaluation.
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-21 and brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center Phase II Trial of Ibrutinib Plus Brentuximab Vedotin in Relapsed/Refractory Hodgkin Lymphoma|
|Study Start Date :||June 20, 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
|Experimental: Treatment (Ibrutinib plus Brentuximab Vedotin)||
Drug: Brentuximab Vedotin
- CR rate; based on the Cheson criteria [ Time Frame: Up to 2 years ]The complete response rate will be calculated as the percent of evaluable patients that have confirmed CR; exact 95% confidence intervals will be calculated for this estimate.
- Duration of overall response [ Time Frame: Up to 2 years ]The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR), per Cheson criteria, (whichever is first recorded) until the first date that relapsed or progressive disease is objectively documented.
- Number of patients with treatment-related adverse events (overall), scored using the CTCAE version 4.03 [ Time Frame: Up to 2 years ]
3a. Number of patients with treatment-related adverse events (by organ system), as assessed by CTCAE version 4.03.
3b. Number of patients with treatment-related adverse events (by grade, within each organ system), as assessed by CTCAE version 4.03.
3c. Time to onset for each treatment-related adverse event, calculated as time from start of treatment to time of onset.
3d. Duration of each treatment-related adverse event, calculated as time from initial detection (start date) of adverse event to documented resolution (stop date).
3e. Association of adverse event to treatment, defined as an adverse event with an attribution of at least possibly related to the study regimen.
- ORR: Overall Response Rate [ Time Frame: Up to 2 years ]The overall response rate will be calculated as the percent of evaluable patients that have confirmed CR or PR; exact 95% confidence intervals will be calculated for this estimate.
- OS: Overall Survival [ Time Frame: Duration of time from start of treatment to time of death (due to any cause), assessed up to 2 years ]Will be estimated using the product-limit method of Kaplan and Meier.
- PFS: Progression-free Survival [ Time Frame: Duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years ]Will be estimated using the product-limit method of Kaplan and Meier.
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): NCT02744612
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Robert W. Chen, MD 626-256-4673|
|Principal Investigator: Robert W. Chen, MD|
|University of California San Diego||Not yet recruiting|
|La Jolla, California, United States, 92093|
|Contact: Carolyn M. Mulroney, MD 858-822-6600|
|Principal Investigator: Carolyn M. Mulroney, MD|
|United States, New York|
|Weill Medical College of Cornell University||Not yet recruiting|
|New York, New York, United States, 10065|
|Contact: Peter Martin, MD 646-962-2064|
|Principal Investigator: Peter Martin, MD|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Not yet recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Kami Maddocks, MD 614-688-7942|
|Principal Investigator: Kami Maddocks, MD|
|Principal Investigator:||Robert Chen, MD||City of Hope Medical Center|