Obinutuzumab in Combination With Ibrutinib in Treating Patients With Relapsed Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT02736617|
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Mantle Cell Lymphoma Refractory Mantle Cell Lymphoma||Drug: Ibrutinib Other: Laboratory Biomarker Analysis Biological: Obinutuzumab||Phase 2|
I. Best overall response of complete response/partial response (CR/PR).
I. Toxicity defined as any adverse event (AE) grade 3 and higher. II. Progression free survival.
I. Gene expression profiling using Lymph5Cx test. II. Sequencing using the ion torrent platform (76 gene panel for known mutations in lymphoma).
III. Sequencing of BTK to evaluate for BTK mutations. IV. Minimal residual disease testing (MRD by flow cytometry and targeted sequencing post treatment).
Patients receive obinutuzumab intravenously (IV) over 30 minutes on days 1, 8, 15 (course 1) and day 1 (courses 2-6). Patients also receive ibrutinib orally (PO) once daily (QD) beginning on day 1 (course 1). Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving partial response (PR) continue to receive obinutuzumab IV every 2 months and ibrutinib PO QD for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Obinutuzumab (GA-101) in Combination With Ibrutinib (I) for the Treatment of Relapsed Mantle Cell Lymphoma|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||July 2021|
Experimental: Treatment (obinutuzumab and ibrutinib)
Patients receive obinutuzumab IV on days 1, 8, 15 and ibrutinib PO QD of first treatment course. Patients then receive obinutuzumab IV on day 1 and ibrutinib PO QD from 2-6 treatment courses. Patients who have PR continue to receive obinutuzumab IV every 2 months and ibrutinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Best overall response of CR/PR, measured from the start of treatment until disease progression/recurrence [ Time Frame: Up to 5 years ]A point and interval estimate (95% confidence interval) will be provided.
- Incidence of toxicity, defined as any adverse event grade 3 or higher, classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 5 years ]
- Progression free survival (PFS) [ Time Frame: Time from the first day of combined study treatment (obinutuzumab plus ibrutinib -day 16 of course 1) to disease progression or death within 30 days of the last study drug administration, whichever occurs first, assessed up to 5 years ]Kaplan-Meier method will be used to estimate PFS.
- Gene expression profiling using Lymph5Cx test [ Time Frame: At baseline ]
- MRD by flow cytometry and next generation sequencing post treatment [ Time Frame: At baseline ]A logrank test will be used to compare PFS between patients with and without MRD negativity after induction (obinutuzumab plus ibrutinib) treatment.
- Sequencing of BTK to evaluate for BTK mutations [ Time Frame: At baseline ]A chi-square test will be used to compare the ORR between patients with and without BTK mutations.
- Sequencing using the ion torrent platform (for MRD and known mutations in lymphoma) [ Time Frame: At baseline ]A logrank test will be used to compare PFS between patients with and without MRD negativity after induction (obinutuzumab plus ibrutinib) treatment.
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): NCT02736617
|United States, Oregon|
|OHSU Knight Cancer Institute||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Stephen E. Spurgeon 503-494-8950 email@example.com|
|Principal Investigator: Stephen E. Spurgeon|
|Principal Investigator:||Stephen Spurgeon||OHSU Knight Cancer Institute|