Bendamustine, Obinutuzumab, and Venetoclax in Patients With Untreated Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT03872180|
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : April 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|CCND1 Positive Mantle Cell Lymphoma t(11;14) Positive||Drug: Bendamustine Biological: Obinutuzumab Drug: Venetoclax||Phase 2|
I. To evaluate the efficacy of the combination of bendamustine, obinutuzumab and venetoclax in patients with untreated mantle cell lymphoma.
I. To evaluate the safety and dose intensity of the combination of bendamustine, obinutuzumab and venetoclax in untreated mantle cell lymphoma.
II. To explore methods of determining molecular remission for patients with untreated mantle cell lymphoma (MCL).
III. To evaluate long-term outcomes including progression-free and overall survival for patients with untreated MCL who receive the combination.
Patients receive venetoclax orally (PO) on days 1-28 of course 1 and days 1-10 of subsequent courses, bendamustine intravenously (IV) on days 1 and 2, and 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 unaccepted toxicity.
After completion of study treatment, patients are followed up at 45-60 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Evaluation of Bendamustine, Obinutuzumab and Venetoclax in Patients With Untreated Mantle Cell Lymphoma|
|Actual Study Start Date :||April 11, 2019|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||April 30, 2026|
Experimental: Venetoclax, bendamustine, obinutuzumab
Patients receive venetoclax PO on days 1-28 of course 1 and days 1-10 of subsequent courses, bendamustine IV on days 1 and 2, and 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 unaccepted toxicity.
Other Name: SDX-105
- Rate of complete response at completion of induction therapy with this combination [ Time Frame: Up to 2.5 years from study start ]Response will be assessed by positron emission tomography (PET)/computerized tomography (CT) imaging according to the Lugano Classification for response assessment in lymphoma, developed at the 2014 International Conference on Malignant Lymphoma.
- Rate of minimal residual disease (MRD) negative complete response by ClonoSEQ mantle cell lymphoma (MCL) assay [ Time Frame: Up to 7 years from study start ]MRD will be assessed by peripheral blood using the ClonoSEQ assay available from Adaptive Biotechnologies.
- Overall response rate [ Time Frame: Up to 7 years from study start ]Will be summarized descriptively.
- Time to tumor progression [ Time Frame: Up to 7 years from study start ]Will be summarized descriptively.
- Progression free survival (PFS) [ Time Frame: Up to 7 years from study start ]Will be described using the Kaplan-Meier methodology. Some patients may undergo consolidative autologous stem cell transplant without evidence of disease progression. This will not be counted against PFS.
- Overall survival [ Time Frame: Up to 7 years from study start ]Will be described using the Kaplan-Meier methodology.
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): NCT03872180
|Contact: Jonathon B. Cohen, MD, MSemail@example.com|
|United States, Georgia|
|Emory University Hospital/Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Vanessa Smith 404-778-2419 firstname.lastname@example.org|
|Emory Saint Joseph's Hospital||Recruiting|
|Atlanta, Georgia, United States, 30342|
|Contact: Alicia Escobar 678-843-7029 email@example.com|
|Contact: Krystal Reese 678-843-5911 firstname.lastname@example.org|
|Emory Johns Creek Hospital||Recruiting|
|Johns Creek, Georgia, United States, 30097|
|Contact: Pamela Bourbo, RN, MPH 678-843-6875 email@example.com|
|Contact: Somini John firstname.lastname@example.org|
|Principal Investigator:||Jonathon B. Cohen, MD, MS||Emory University|