Non-Hodgkin’s Lymphoma Study

Principal Investigator: R. Vinod Parameswaran, MD

Sub-Investigators: Kelly McCaul, MD; Michael Robinson, MD; Mark Huber, MD; Amy Krie, MD; Addison Tolentino, MD; Stephen Medlin, MD; Kristen Hurley, CNP; Tammie Smart, CNP

Study Coordinator: Erika Meyer, RN

Study Description: An Open Label, Randomized, Phase 3 Study of Inotuzumab Ozogamicin Therapy in Subjects with Relapsed or Refractory CD22-positive, Follicular B-Cell Non-Hodgkin's Lymphoma

Overview: The purpose of this clinical drug study is to determine the safety and effectiveness of an investigational medication in combination with rituximab in treating patients with Non-Hodgkin’s Lymphoma. Eligible individuals will participate in the study for approximately 5 years.

Participants will be in one of two treatment arms: one group will receive the investigational medication in combination with rituximab and the other group will receive rituximab in another combination.

Inclusion Criteria:

• Men and women, ages 18 and older
• Diagnosis of CD20/CD22-positive follicular lymphoma
• Have received 1 or 2 prior treatment regimens containing the administration of rituximab as either a single agent or in combination

Exclusion Criteria:

• Women who are pregnant, breastfeeding or planning to become pregnant
• Prior autologous transplant within 6 months
• Prior allogeneic hematopoietic stem cell transplant
• Prior treatment with anti-CD22 antibodies or any previous radio-immuno therapy
• Any evidence of serious active infection

Contact: Erika Meyer, RN

Phone:  (605) 322-3086

Email: erika.meyer@avera.org

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