Follicular Lymphoma Study

Principal Investigator: Kelly McCaul, MD

Sub-Investigators: R. Vinod Parameswaran, MD; Stephen Medlin, DO; Addison Tolentino, MD; Tammie Smart, CNP; Kristen Hurley, CNP; Adam Walker, CNP

Study Coordinator: Erika Meyer, RN

Study Description: A Two-Arm, Non-Randomized, Multi-Center, Phase 2 Study of VELCADE^® (bortezomib) in Combination with Rituximab, Cyclophosphamide, and Prednisone with or without Doxorubicin followed by Rituximab Maintenance in Subjects with Relapsed Follicular Lymphoma

Overview: The main purpose of this study is to determine whether the addition of VELCADE to two different drug combinations is safe and effective for individuals with follicular lymphoma. The combinations are as follows:

• VELCADE, Rituximab, Cyclophosphamide and Prednisone
• VELCADE, Rituximab, Cyclophosphamide, Prednisone and Doxorubicin

VELCADE has not been approved by the FDA for the treatment of follicular lymphoma. Rituximab, Cyclophosphamide, Prednisone and Doxorubicin are all commonly used agents in the treatment of lymphoma. The addition of VELCADE to these drugs in this study is experimental.

Inclusion Criteria:

• Men and women, age 18 and older
• Pathological diagnosis of follicular lymphoma
• Documented relapse or progression following previous treatment

Exclusion Criteria:

• Women who are pregnant, breastfeeding or planning to become pregnant
• Received VELCADE as a prior treatment
• Active systemic infection requiring treatment

Contact: Erika Meyer, RN

Phone:  (605) 322-3086

Email:   erika.meyer@avera.org