RFA#C14-0042 Ancillary research using clinical data and biospecimens from the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Released: September 23, 2014 Request for Applications Ancillary research using clinical data and biospecimens from the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Many questions remain unanswered about hematopoietic cell transplantation. Studies that have prospectively collected clinical data and accompanying biospecimens can be particularly meaningful. The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) is calling for proposals from investigators who wish to address supplemental questions that develop from our portfolio of prospective clinical trials and available research specimens. Proposed studies may include, but should not be limited to: secondary endpoint analyses from the clinical trials analyses of subsets for specific endpoints addressed in the clinical trials genetic modifiers of response to transplant including HLA and non-HLA genetic studies of patients and donors biomarkers predictive of complications or response genetic or biological markers associated with the underlying disease for which the patient received transplantation, addressing questions beyond the efficacy and outcome of the transplant itself. The rich resource of clinical data and literally thousands of biospecimens from seven completed prospective BMT CTN trials are currently available for the proposed work. A listing of these trials and available biospecimen sample types are listed below. Detailed information regarding the clinical protocols, research sample collection schedules, available sample types, processing & storage information and available biospecimen inventories for each of these specimen collections can be found on the public BMT CTN website (https://web.emmes.com/study/bmt2/Researchsample.html). BMT CTN 0102: Patient - Serum, PBMC; Donor - Stem cell product aliquots BMT CTN 0201: Patient - Serum and Plasma BMT CTN 0302: Patient - Whole blood, Buccal cells, and Serum BMT CTN 0401: Patient - PBMC BMT CTN 0402: Patient – Serum and Plasma; Donor – Baseline Serum, Plasma and WBC Pellets BMT CTN 0701: Patient - PBMC BMT CTN 0802: Patient - Whole blood, Buccal cells, and Plasma Application Instructions IMPORTANT DATES AND DEADLINES Application & Project Milestone Schedule Release of RFA#C14-0042 September 23, 2014 Written Questions can be submitted via E-Mail through: November 7, 2014 (Questions will be promptly reviewed by the BMT CTN DCC and a response returned directly to the investigator submitting the question.) Proposals Due at 4:00 p.m. Central Time November 15, 2014 Project Selections and Award Announcements Project Start Date Completion of Selected Ancillary Studies Presentation of Results to BMT CTN Steering Cmte By December 17, 2014 January 1, 2015 By December 31, 2015 February 10, 2015 (Tandem Meetings, San Diego) Responses must be submitted via Email to: Renée Carby – Contracts Representative National Marrow Donor Program 3001Broadway Street N.E. Broadway Ridge, Suite 100 Minneapolis, MN 55413-1753 Telephone: 612.884-8738 Email: rcarby@nmdp.org Application Guidelines Applications can include requests for samples and clinical data collected through the listed prospective trials, funding to support EMMES/CIBMTR biostatistical assistance as needed for analysis at the rate of $105/hr. and/or funding to support testing the biospecimens. Applications will be received for projects that can be completed within one year from the time of award. Applications (4 page proposal; 2 page study budget maximum) should be submitted using the attached proposal and budget submission form. Proposals should provide a detailed rationale, background, question(s) to be addressed, pertinent methods plus detailed specification of the requested clinical data and biospecimens. The RFA has set a not-to-exceed 28% indirect/administrative rate as funds will come out of the BMT CTN patient reimbursement budget used for protocols. (Protocol budgets incorporate the 28% indirect rate). Additionally, purchasing of equipment will not be covered by this award. It is expected that results obtained from the completed study will result in an abstract to be presented at a scientific meeting and/or will form the basis of pilot data for a future grant application. Review Process Applications will be reviewed by an Ad Hoc Committee appointed by the BMT CTN Executive Committee. Applications will be awarded on the basis of scientific merit, impact of the proposed study, feasibility of completion within a one year timeline and the scope of the requested budget. Final project funding decisions will be made by the Executive Committee based upon study rankings and available funding. Awardees will be notified in mid-December and provided an agreement. Funds will be available for disbursement by December 31, 2014, pending required contractual documentation. For questions concerning the biospecimen inventory please contact Alan Howard at ahoward@nmdp.org . For questions concerning the RFA, or the application and submission process please contact Renee Carby, Contract Manager at rcarby@nmdp.org, Questions will be promptly reviewed by the BMT CTN DCC and a response returned directly to the investigator submitting the question.