Owen A. O'Connor, MD, PhD, Director, Lymphoid Development & Malignancy Program and Chief, Lymphoma Service, Columbia University, Herbert Irving Comprehensive Cancer Center, New York, is the international study chair.
In accordance with the PROPEL study design, in January 2007, the DMC completed an interim analysis of safety data based on the first 10 patients enrolled to the study who completed at least one cycle of treatment with PDX, and recommended that the trial continue per the protocol. Also in accordance with the study design, in September 2007, an interim analysis of patient response and safety data was conducted based on the first 35 patients enrolled to the study who completed at least one cycle of treatment with PDX. The results of the interim analysis of patient response data exceeded the pre-specified threshold for continuation of the trial, which required a minimum of four responses (complete or partial) out of the first 35 evaluable patients, as determined by independent oncology review. In addition, the DMC identified no major safety concerns and recommended that the trial continue per the protocol.
The PROPEL trial is being conducted under an agreement with the United
States Food and Drug Administration (FDA) under its special protocol
assessment (SPA) process. The SPA process allows for FDA evaluation of a
clinical trial protocol intended to form the primary basis of an efficacy
claim in support of an NDA, and provides an agreement that the study
design, including trial size, clinical endpoints and/or data analyses are
acceptable to the FDA. The FDA granted orphan drug designation to PDX for
the treatment of T-cell lymphoma in July 2006 and granted fast track
designation to PDX for the treatment of patients with T-cell lymphoma in
September 2006. In April 2007, the Commission of the European Communities,
with a favorable opinion of the Comm
|SOURCE Allos Therapeutics, Inc.|
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