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A Phase II Evaluation of Bendamustine, Obinutuzumab and Venetoclax in Patients with Untreated Mantle Cell Lymphoma

Status
Active
Cancer Type
Lymphoma
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03872180
Protocol IDs
Winship4363-18 (primary)
NCI-2018-00995
IRB00102827
Study Sponsor
Emory University Hospital / Winship Cancer Institute

Summary

This phase II trial studies how well bendamustine, obinutuzumab, and venetoclax work in treating patients with mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving bendamustine, obinutuzumab, and venetoclax may work better in treating patients with mantle cell lymphoma.

Objectives

PRIMARY OBJECTIVES:
I. To evaluate the efficacy of the combination of bendamustine, obinutuzumab and venetoclax in patients with untreated mantle cell lymphoma.

SECONDARY OBJECTIVES:
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.

OUTLINE:
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.

Treatment Sites in Georgia

Emory Johns Creek Hospital


6325 Hospital Parkway
Johns Creek, GA 30097
www.emoryjohnscreek.com

Emory Saint Joseph's Hospital


5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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