A Phase I/IB Study of Ipilimumab in Patients With Relapsed Hematologic Malignancies After Allogeneic Hematopoietic Cell Transplantation
PRIMARY OBJECTIVES:
I. To determine the maximum-tolerated dose (MTD) of ipilimumab administered to patients with
relapsed hematologic malignancies following allogeneic stem cell transplantation. (Phase I)
II. To characterize the toxicity of ipilimumab administered at the MTD in this patient
population. (Phase Ib)
SECONDARY OBJECTIVES:
I. To assess response rate by simple descriptive summary statistics. II. To assess
progression free and overall survival by the Kaplan-Meier method.
TERTIARY OBJECTIVES:
I. To assess the phenotypic and functional effects of ipilimumab on immune cells.
II. To assess tumor glucose metabolism using whole-body fludeoxyglucose F 18-positron
emission tomography (FDG-PET) with optional dual time-point imaging.
OUTLINE: This is a dose-escalation study.
INDUCTION PHASE: Patients receive ipilimumab intravenously (IV) over 90 minutes on day
1.Treatment repeats every 21 days for 4 courses in the absence of disease progression or
unacceptable toxicity.
MAINTENANCE PHASE: Patients receive ipilimumab IV over 90 minutes every 12 weeks beginning
at week 24 and then at weeks 36, 48, and 60 in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 year.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD of ipilimumab according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
At 12 weeks
Yes
Matthew Davids
Principal Investigator
Dana-Farber Cancer Institute
United States: Food and Drug Administration
NCI-2013-00739
NCT01822509
April 2013
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |