A Phase I Study of Ipilimumab in Combination With Rituximab in Patients With Relapsed/Refractory CD20+ B-Cell Lymphoma
PRIMARY OBJECTIVES:
I. To determine a recommended phase II dose for ipilimumab in combination with rituximab.
SECONDARY OBJECTIVES:
I. To obtain preliminary information on the effect of adding ipilimumab to rituximab in
regard to: immune response; clinical anti-tumor response/overall remission rate (ORR)
(complete remission + partial remission); progression free survival (PFS).
OUTLINE: This is a dose-escalation study of ipilimumab followed by a randomized study.
PART I:
INDUCTION: Patients receive ipilimumab intravenously (IV) over 90 minutes once every 3 weeks
for 12 weeks and rituximab IV over 2-6 hours once weekly for 4 weeks.
MAINTENANCE: Patients receive ipilimumab IV over 90 minutes and rituximab IV over 2-6 hours
once every 12 weeks for up to 1 year.
PART II: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive rituximab
IV over 2-6 hours once weekly in weeks 1-4 and ipilimumab IV over 90 minutes once weekly in
weeks 1, 4, 7, and 10. Patients then receive ipilimumab IV over 90 minutes and rituximab IV
over 2-6 hours once every 12 weeks for up to 1 year in the absence of disease progression or
unacceptable toxicity.
ARM II: Patients receive rituximab IV over 2-6 hours once weekly in weeks 1-4 and ipilimumab
IV over 90 minutes once weekly in weeks 3, 6, 9, and 12. Patients then receive ipilimumab IV
over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 12 months.
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4 ( v4)
Tables will be created to summarize the toxicities and side effects by dose, course, organ and severity.
Up to 12 months
Yes
Joseph Tuscano
Principal Investigator
Beckman Research Institute
United States: Food and Drug Administration
NCI-2012-02213
NCT01729806
November 2012
Name | Location |
---|---|
City of Hope | Duarte, California 91010 |
UC Davis Comprehensive Cancer Center | Sacramento, California 95817 |
University of Southern California | Los Angeles, California 90033 |
Penn State Hershey Children's Hospital | Hershey, Pennsylvania 17033 |