Abstract #301738


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JSM 2002 Abstract #301738
Activity Number: 110
Type: Contributed
Date/Time: Monday, August 12, 2002 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section*
Abstract - #301738
Title: Adaptive Decision-making in a Lymphocyte Infusion Trial
Author(s): Lurdes Inoue*+ and Peter Thall+
Affiliation(s): U. T. M. D. Anderson Cancer Center and University of Texas
Address: 1515 Holcombe Boulevard, Box 447, Houston, Texas, 77030, USA 1515 Holcombe Boulevard, Box 447, Houston, Texas, 77030, USA
Keywords: adaptive randomization ; Bayesian design ; dose finding ; leukemia
Abstract:

We propose an adaptive Bayesian design for a clinical trial of an experimental treatment for patients with hematologic malignancies who experienced disease recurrence. The primary scientific goal is to determine the time for donor lymphocyte infusion that induces the highest probability of treatment success. Using a parametric model accounting for toxicity, time to white blood cell recovery, and survival time, we developed a design that includes an algorithm for between-patient immunotherapy dose de-escalation based on liver toxicity data, and an adaptive randomization among five possible infusion times according to their most recent posterior success probabilities. Our simulation results show that the design reliably selects the best infusion time while randomizing greater proportions of patients to superior infusion times.


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