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

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.

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