Protocol Participation Support

Background
An important mandate of the National Cancer Institute (NCI) is to develop new treatments for cancer. In a highly integrative approach, the Lymphoid Malignancies Branch (LYMB) of the NCI's Center for Cancer Research (CCR) utilizes recombinant molecules produced by NCI's Biopharmaceutical Development Program and commercial agents as potential immune system modulators. The LYMB Clinical Trials Team coordinates several phase I/phase II clinical trials under protocols that have been approved by the NCI's Institutional Review Board (IRB) for the study of adult T-cell leukemia/lymphoma (ATL). The LYMB's current portfolio consists of the following protocols:
• NCT01712659: "Phase I/II Trial Evaluating the Safety and Efficacy of Ruxolitinib in Patients with Smoldering or Chronic Adult T-Cell Leukemia (ATL)."
• NCT02689453: "Subcutaneous Recombinant Human IL-15 (rhIL-15) and Alemtuzumab for People with Refractory or Relapsed Chronic and Acute Adult T-cell Leukemia (ATL)."
• NCT00001582: "Collection of Blood, Bone Marrow, and Tissue Samples for Investigation of the Human Immune Response, Lymphoma Biology and HTLV-1 Infection."
• LOI: "Recombinant Human IL-15 (rhIL-15) and Mogamulizumab for Patients with Refractory or Relapsed Adult T-cell Leukemia and Mycosis Fungoides/Sezary Syndrome."

(Detailed information about each of the above listed trials is public information and can be accessed by visiting clinicaltrials.gov and searching by NCT number).

Purpose.
The overarching goal of LYMB's clinical trials is to improve the understanding and treatment of ATL. ATL is a rare and highly aggressive lymphoproliferative disease that results from chronic infection with the retrovirus Human T-cell Lymphotropic Virus type 1 (HTLV-1). HTLV-1 is most pervasive in the Caribbean basin-specifically Jamaica-where the majority of ATL cases reside. Access to this population is crucial to the success of LYMB's study; therefore, LYMB requires a contractor with a strong presence in Jamaica that is capable of effectively identifying, diagnosing and referring ATL patients to LYMB's protocols.

. Awarded Vendors: The University of the West Indies. Contract Award Dollar Amount: $585,281. Contract Award Date: 2019-10-31.