Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas
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|ClinicalTrials.gov Identifier: NCT03198026|
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin's Lymphoma||Drug: Ibrutinib Drug: Obinutuzumab||Phase 2|
I. To assess the efficacy of the combination of ibrutinib and obinutuzumab in chemotherapy naive patients with indolent lymphomas.
I. To assess progression free survival rates and overall survival rates in indolent lymphomas.
II. To assess safety and tolerability of the combination. III. To evaluate response using positron emission tomography (PET) and correlate PET negativity with durability of response.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II, Single Arm, Open Label Multi-center Study of Obinutuzumab and Ibrutinib in the Front Line Treatment of Indolent Non-Hodgkin's Lymphomas|
|Actual Study Start Date :||February 20, 2018|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||January 2022|
Experimental: Treatment (ibrutinib, obinutuzumab)
Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab IV on days 1, 8, and 15 of course 1 and day 1 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 months after course 6, patients with stable disease will continue to receive obinutuzumab every 2 months for a total of 12 doses.
- Overall response rate in patients with newly diagnosed indolent lymphoma requiring treatment [ Time Frame: Two years ]Response will be assessed by the revised Lugano. Will compute estimates of response, along with corresponding confidence intervals, using appropriate exact methods that take into account the 2-stage design.
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): NCT03198026
|Contact: Ubaldo Martinez-Outschoorn, MD||215-955-8874||Ubaldo.Martinez-Outschoorn@jefferson.edu|
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Ubaldo Martinez-Outschoorn, MD 215-955-8874 Ubaldo.Martinez-Outschoorn@jefferson.edu|
|Principal Investigator:||Ubaldo Martinez-Outschoorn, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|