Allos Therapeutics to launch the COMPLETE registry for patients with PTCL

Dec 3 2009

Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced the launch of an international registry designed to address the urgent need to better understand treatment patterns and outcomes for patients with peripheral T-cell lymphoma (PTCL). The registry, known as COMPLETE (Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment), is a global observational study that will enroll patients with newly-diagnosed PTCL and obtain data regarding longitudinal treatment patterns and outcomes. Complementing other registries that focus on PTCL incidence or prognosis at diagnosis, COMPLETE is expected to provide – for the first time – important and detailed information on PTCL disease management across various treatment regimens, including drug therapy, stem cell transplant and radiation therapy. The registry will be launched during the 51st Annual Meeting of the American Society of Hematology (ASH) in New Orleans, LA.

COMPLETE is designed to collect data on a real-time basis from individual healthcare practitioners over three years of patient enrollment and two years of follow up. It is anticipated that approximately 75 sites will participate in the registry, representing academic, hospital and community practices in both the U.S. and Europe. Data obtained from the registry will be presented in scientific meetings and published in peer-reviewed journals.

“Knowledge of PTCL, which is a complicated group of diseases, comes principally from small, disparate clinical trials,” explained Francine Foss, M.D., professor, C-Director, Yale Cancer Center, Lymphoma, Leukemia and Myeloma Program, and chair of the COMPLETE International Steering Committee. “Detailed registries such as COMPLETE can be invaluable in providing ‘real-world’ data on specific populations of patients, enabling treating physicians to better understand how patients are being treated and the outcomes of treatment, both in routine clinical practice and in clinical trials. Ultimately, we believe these findings will provide more insight into the treatment options for patients with PTCL.”

The array of cancer treatments and supportive care choices, as well as disease recurrence and treatment outcomes, will be gathered into a database via a confidential web-based system. COMPLETE is also designed to evaluate whether the results of clinical studies are being incorporated effectively into daily practice and compare treatment practices in community and academic settings.

“Existing T-cell lymphoma registries focus primarily on disease incidence and patient prognosis or are institution specific, thereby creating a need for a broader registry, like COMPLETE, to evaluate treatment patterns on a more comprehensive basis,” said Paul L. Berns, president and chief executive officer of Allos. “COMPLETE is unique in that it is the first time a broader registry for patients with PTCL is designed to characterize treatment patterns in academic and community practices across the U.S. and in Europe. Our hope and vision is that COMPLETE will enable practitioners who treat patients with aggressive PTCL to make more informed treatment decisions based on a better understanding of potential treatment options and outcomes.”

“With rare diseases, the medical community often has very little access to information about treatments and outcomes,” said Peter L. Saltonstall, president and chief executive officer of the National Organization for Rare Disorders (NORD). “Databases that provide such information can give medical providers valuable insight that may lead to better patient care.”

SOURCE Allos Therapeutics, Inc.