Ipilimumab in Treating Patients With Relapsed Hematologic Malignancies After Donor Stem Cell Transplant
Brief description of study
This phase I/Ib trial studies the side effects and the best dose of ipilimumab in treating
patients with cancers of the blood and blood-forming tissues (hematologic cancers) that have
returned after donor stem cell transplant. Monoclonal antibodies, such as ipilimumab, may
interfere with the ability of cancer cells to grow and spread.
Clinical Study Identifier: NCT01822509
Detailed Study Description
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)
I. To assess response rate by simple descriptive summary statistics. II. To assess
progression free and overall survival by the Kaplan-Meier method.
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
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
After completion of study treatment, patients are followed up for 1 year.