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Phase II Study of Bendamustine and Rituximab plus Venetoclax in Untreated Mantle Cell Lymphoma over 60 Years of Age

This study is to see if venetoclax in combination with bendamustine and rituximab chemotherapy is effective in treating people who have mantle cell lymphoma and to examine the side effects, good and bad, associated with this combination .
Jennifer Petrask at jpetrask@pennstatehealth.psu.edu or 717-531-8678
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03834688
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Inclusion Criteria:
Must have histologically confirmed (biopsy-proven) diagnosis of mantle cell lymphoma (MCL)
Must have measurable or evaluable disease as defined as a lymph node measuring >1.5 cm in any dimension or splenomegaly with spleen >15 cm in craniocaudal dimension
ECOG performance status of 0-2
Adequate organ function as measured by the criteria
Total Bilirubin ≤ 1.5x upper limit of normal (ULN) or ≤ 3x ULN with documented Gilbert’s syndrome
Exclusion Criteria:
Should not have known evidence of central nervous system (CNS) lymphoma
Should not have prior chemotherapy, radiotherapy or immunotherapy for lymphoma
Must not have received a prior allogeneic stem cell transplant or solid organ transplant (except for cornea) for any indication
Must have no active, uncontrolled infections
Must not have active hepatitis B or be chronic carriers of hepatitis B.
Cancer
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Location
Hershey, PA