2023 LLS Academic Clinical Trials Program (ACT)

Eligibility

Citizenship: The program welcomes applications worldwide from appropriate academic institutions and investigators of any nationality.

Degree: Applicants must hold a medical degree (MD or ex-US equivalent). Other advanced degrees (OD, PharmD, PhD) will be considered. Non-independent investigators such as clinical fellows, residents, postdoctoral fellows, instructors, etc. are not eligible.

Leadership and Staffing: The Application will require one Principal Investigator (PI) who is responsible for the preparation and submission of the proposal including budget, the conduct of the research programs, and adherence with all stipulations made by LLS in this document, the LLS Policies & Procedures document, and in the funding agreement, if funded.

Relevance: The proposed clinical research must be focused on developing innovative treatments in blood cancer or associated pre-malignant conditions. Additional correlative studies to determine mechanism of action, biomarker identification and/or patient selection are allowed.

The Principal Investigator (PI):

• MUST be a person (companies or institutions are not eligible).
• MUST be an independent investigator, with demonstrated experience and training to be able to organize, manage and implement the clinical trial to meet milestones and timelines, and to protect the rights and welfare of the human subject participants.
• MUST be an established investigator, defined as a researcher with 3 or more years in an independent faculty appointment.
• May only submit one ACT application per program cycle; and cannot serve as a PI or Co- PI on more than ONE ACT application per cycle. If applying to another LLS program, the goals of each proposal must be substantially different.
• CAN serve as a Collaborator on other applications provided the aims differ.

A Co-Principal Investigator (Co-PI):

• MUST be a person (companies or institutions are not eligible)
• MUST be an independent investigator with an independent appointment, with demonstrated experience and training to organize, manage, and implement their portion of the clinical trial and/or project to meet milestones and timelines.
• If the PI has the necessary track record in blood cancer research, a Co-PI with complementary experience may strengthen the proposal but is not required.
• May be named as PI or Co-PI on one application per ACT program cycle.
• CAN serve as a Collaborator on other applications provided the aims differ.
• MUST be designated at the LOI phase.

Scientific Staff/Collaborators/Other Key Personnel

• MUST be a person (companies or institutions are not eligible).
• May strengthen the work proposed but is not required.
• May provide expert insight, guidance, or feedback on research progress.
• May be included on different projects or programs provided the aims differ.

Summary

The Leukemia and Lymphoma Society (LLS) recognizes the scientific and clinical merit of research developed and conducted by independent investigators affiliated with academic institutions. Such investigator-initiated trials (IITs) play an important role in developing experimental agents to address unmet medical needs, expanding the use of approved therapeutics, and improving the use of novel treatment regimens in real-world clinical settings. To support this important aspect of research, LLS created the Academic Clinical Trials Program (ACT) in 2022-23, and now presents a second request for applications.

The LLS ACT initiative is a clinical trial award program designed to develop cutting edge treatments that will have meaningful impact for blood cancer patients. These awards will fund clinical trials, up to $1M USD over a period of up to three years.

LLS is seeking truly novel advances. The primary focus will be Phase 1 or 2 clinical trials with novel experimental agents. Repurposing of approved therapies into novel indications will also be considered. Investigators conducting existing trials and expansion of existing trials are welcome to apply. Investigation of corporate-owned assets is allowed. If a corporate asset is studied, a clear path to market must be obtained and demonstrated. Proposals may include correlative studies including but not limited to biomarker identification, mechanism of action studies, and/or patient selection characteristics.

Application Process

Registration: Both the applicant and institution must be registered in the LLS Research Portal. If you have applied to LLS in the past, you do not need to create a new registration. Simply log in with your username and password. If you forgot your password, click the “reset or create password” link and enter your email address. The system will send your username and a link to update your password. Once updated, you can begin the LOI. If you are a first-time user to the LLS Research Portal, please complete the intake form located at this link: Account Creation Request.

Letter of Intent (LOI): Each applicant must submit the LOI by October 25, 2023, at 1:00pm MT via the LLS Research Portal (https://lls.fluxx.io). The applicant should carefully craft the information requested in the LOI as this information is automatically populated into the full application and is subject to the “Changes” clause listed in the 2023 ACT Guidelines & Instructions. There are two main aspects to the Letter of Intent Phase: all Fluxx webform fields and the “Previous Studies/Preliminary Data/Trial Summary” (2 page maximum) downloadable template for completion.

The LOI for ACT will be reviewed after the deadline. If the LOI is approved, the applicant will be notified by an automated email from the LLS Research Portal stating that they may proceed to the full application phase. Applicants may also check the status of their LOI on the LLS Research Portal.

Applicants must obtain internal institutional approval from the University of Calgary prior to submitting their LOI to the sponsor. Initiate required University of Calgary internal approvals by completing a Pre-Award/Letter of Intent record in RMS (https://my.rms.ucalgary.ca). Attach a copy of your completed Fluxx webform and a draft of your “Previous Studies/Preliminary Data/Trial Summary” document. Submit for approvals from your department head and/or faculty Associate Dean (Research). Please ensure that you allow time for academic approvals prior to the Research Services Office internal review deadline of 12:00pm MT, October 20, 2023.

Full Application: Applicants invited to submit full applications should email Chantal Lemire (chantal.lemire@ucalgary.ca) for additional information on the next stage of this competition.

Overhead

15% of Amount Requested (not to exceed $150,000).

Pre-application deadlines

RSO internal deadline

Pre-application program deadline

Application deadlines

RSO detailed review deadline

RSO final internal review deadline

Program application deadline

NOTE: Consult your Faculty Associate Dean (Research) (ADR) regarding Faculty-specific deadlines and submission processes.

Principal Investigators: Complete a Research Management System (RMS) record, including a copy of your complete application, and submit this for approvals in RMS.

Approvals: The University of Calgary requires that all funding applications be approved prior to submission. Approval requires signatures via RMS in the following order:

• Principal Investigator
• Department Head
• Faculty ADR/Dean
• Research Services (on behalf of the Vice-President Research)

Read the Meaning of Grant Signatures policy to understand what your approval means. Please see the agency guidelines for details about which signatures are required on your application, as it may differ from internal requirements.

Late submissions: Late submissions will only be accepted in cases of medical or family emergencies, or other exceptional circumstances. If you submit your RMS record to Research Services after the internal deadline has passed, you must secure additional approvals. Please read: Late Applications Process.

Additional Resources

2023 ACT Guidelines & Instructions

Research Programs Policies & Procedures (Revised April 2020)

ACT Funding Agreement Template

Research Portal Access

LLS Research Portal