Clinical Trial: Bruton’s Tyrosine Kinase (Btk) Inhibitor PCI-32765 in Relapsed/Refractory Mantle Cell Lymphoma

Update: this study is closed to enrollment. 

Bruton tyrosine kinase (Btk) is an enzyme that plays a crucial role in the development of the normal immune system. Recent studies indicate that Btk may also play a role in many B-cell lymphomas.

PCI-32765 is an investigational drug that irreversibly inhibits Btk. A phase 1 trials performed at several sites, including Weill Cornell Medical Center, demonstrated that PCI-32765 was well tolerated with minimal side effects.

In this phase 2 study, we are evaluating the efficacy of PCI-32765 (four pills take once daily) in patients with previously treated mantle cell lymphoma. We hope to learn how well PCI-32765 works and more about its side-effect profile.

To learn more about this study, please contact June Greenberg, RN at (212) 746-2651 or email June at jdg2002@med.cornell.edu.

Click here to view the clinical and research profile of Peter Martin, MD, the physician leading the study at Weill Cornell Medical Center.

Weill Cornell Clinical Trial: PD 0332991 Plus Bortezomib in Patients With Relapsed Mantle Cell Lymphoma

Mantle cell lymphoma is characterized by a genetic defect that results in increased production of a protein called Cyclin D1. Another protein called Cdk4/6 works together with Cyclin D1 to release a brake on cell replication. For that reason, mantle cell lymphoma cells replicate more rapidly than other cells.

PD 0332991 is an investigational oral drug (i.e., a pill) that specifically inhibits Cdk4/6. Data from our lab and from an earlier clinical trial performed at Weill Cornell Medical Center suggest that PD 0332991 is able to stop lymphoma cells from replicating in some patients with mantle cell lymphoma.

Bortezomib (Velcade) is approved by the FDA for treatment of patients with relapsed mantle cell lymphoma. Data from our laboratory suggests that PD 0332991 and bortezomib can work together to kill lymphoma cells more effectively than either drug alone.

In this study, we are testing different doses of the combination of PD 0332991 and bortezomib. We hope to learn how to safely combine the two drugs. We also hope to learn more about how both drugs work so that we can use them more effectively in the future.

To learn more about this study, please contact June Greenberg, RN at (212) 746-2651 or email June at  jdg2002@med.cornell.edu.

Click here to view the clinical and research profile of Dr. Peter Martin, the physician leading the study. Click here to view all non-Hodgkin clinical trials at Weill Cornell Medical Center.

Journal Of Clinical Oncology Publishes Clinical Trial Results Of VELCADE Combination In Aggressive Subtypes Of Non-Hodgkin Lymphoma

Phase II results of a Weill Cornell-sponsored clinical trial examining VELCADE® (bortezomib) in patients with previously untreated aggressive lymphoma were published in February 2011 in the Journal of Clinical Oncology. The study was designed to examine the efficacy of VELCADE in combination with the current standard of care (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; R-CHOP) in 76 patients with two aggressive subtypes of lymphoma: mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL).

Dr. John Leonard, the Clinical Director of the Weill Cornell Center for Lymphoma and Myeloma, is the the principal investigator of the study. Click here to read the news release summarizing the results of the study. Click here to read the published research paper in the Journal of Clinical Oncology.

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