Protocol Participant Support

This Modification/Amendment is to post Solicitation 75N91019R00016..

Note: This pre-solicitation notice follows a Sources Sought notice that was released on January 25, 2019 under HHS-NIH-NCI-SS-ETSB-0016-41.

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE.

Title: Protocol Participant 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.

Scope. Identify, diagnose, refer, and provide ongoing administrative support to current and prospective patients in Jamaica for new and existing ATL-related protocols.

REQUIREMENTS
Independently, and not as an agent of the Government, Contractor shall furnish all necessary labor, materials, supplies, equipment, and services not otherwise provided by the Government to perform the following ongoing tasks:

Task 1. Refer Potential Study Participants.
1.1. Identify and interact with the target outpatient or inpatient population within Jamaica.
1.2. Diagnose ATL and screen for prospective study participants (residing in Jamaica) who meet the eligibility criteria specified by LYMB's various clinical trial protocols (listed above) and new trials as identified by LYMB staff. Diagnosis and screening of such patients shall include, but is not limited to (specifics are listed in each protocol) the following:
1.2.1. Standard physical exams and blood draw for complete blood count (CBC).
1.2.2. Blood panels (e.g. acute care panel, hepatic panel, LDH, etc.).
1.2.3. Computed tomography (CT) and/or Positron emission tomography (PET) scans
1.2.4. Tissue biopsy/pathology.
1.2.5. FACS analysis to demonstrate the diagnostic phenotype of ATL cells (CD3dim, CD4+, CD7-, CD8-, and CD25+).
1.2.6. Serum assay for antibodies to the retrovirus (HTLV-1) causing ATL.

1.3 Refer potentially eligible candidates (residing in Jamaica) and forward their medical records to the staff in LYMB, CCR, NCI. LYMB staff will decide on candidate eligibility after review of the records and inform the contractor whether the patient should initiate travel arrangements to come to the NCI for screening and possible enrollment.

Task 2. Provide Ongoing Administrative Support.
2.1 Provide administrative support for the travel of patients selected for inclusion in NCI clinical trials. Contact LYMB's Patient Care Coordinator to coordinate participant travel to the National Institutes of Health's Clinical Center located in Bethesda, MD, United States. This support shall include, but is not limited to, coordinating travel arrangements with the LYMB Patient Care Coordinator, providing transportation schedules, and assisting patients with directions to and from the Clinical Center.

2.2 Provide administrative and financial support in obtaining valid documents required to enter the United States to participants selected to travel to the Clinical Center. This support includes, but is not limited to, submitting applications for passports and visas. (International travel and travel within the United States will be arranged and paid for by the Government).

The Government anticipates that one (1) contract will be awarded with a base period of one (1) year and four (4)- one (1) year option periods beginning on or about November 1, 2019. The NAICS Code is 541990.

The request for proposal (RFP) will be available electronically on or about March 27, 2019 and may be accessed through the FedBizOpps at www.fbo.gov. WE ENCOURAGE ALL RESPONSIBLE SOURCES, PARTICULARLY SMALL BUSINESSES, TO SUBMIT A PROPOSAL, WHICH WILL BE CONSIDERED BY THE AGENCY.

This notice does not commit the Government to award a contract. No collect calls, calls, facsimile, email transmissions, and/or questions will be accepted.

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