CBMTG 0801 Moving Forward …

Activation Timeline

Canadian Sites

Projected Accrual

Site Activation IRB approval Regulatory Documents (Checklist) Centre criteria for myeloablative and RIC HPCT SOP for transplant decision Site Agreement signed Site Initiation (Web conference)

Consent Within 60 days of transplant French and English templates Verbal translation -- if ok with local REB

Thymoglobulin in Unrelated Transplant CBMTG 0801 If you will be undergoing a transplant from an unrelated donor for blood cancer, then you may be eligible for this trial. This trial involves the addition of a drug called Thymoglobulin to the conditioning regimen prior to transplant.

Screening Period Day -60 to Day -8 Study procedures – standard work-up (except for study questionnaires) Health Canada guidelines for IDM’s Questionnaires to be completed prior to start of conditioning

Randomization All I & E must be met Randomize no earlier than 14 days prior to start of the preparative regimen Can be randomized up until 1 day prior to start of preparative Fax or pdf to: Data Management Office (Vancouver)

Study Procedures – Post HPCT Immune Reconstitution

QOL, Chronic GVHD Follow-Up & HE

Project Website

Study Tools Procedures spreadsheet Participant Information Pamphlet (in development) Days post transplant calculator

Study Schedule

Data Collection Case report form posted on website (soon) Forms due within 1 month of time point Data locks q 6 months

AE/SAE Reporting AE’s grade 3 or greater to day 30 CTCAE version 3.0 Day 31 to 24 months – SAE’s only Report to DM Office within 24 hours (DM will report to Health Canada and Genzyme) DSMC meets twice/year and as needed

Infections All grade 4 and 5 infections will be recorded in the Data Collection Forms (and reported as SAEs) Additional information:  Type of organism (suspected or documented);  Activation of CMV requiring treatment  Activation of EBV either with symptoms or requiring treatment  Primary organ involved

Centre Funding CENTRE FUNDING (CIHR) Per Patient Entered:$4000 THYMOGLOBULIN: Order by centre, reimburse ($3900 per patient ) SITE START-UP: $2,000 per site Pharmacy, preparation of IRB submission, etc.

Site Agreements Caroline Woods at McMaster University They will be sent to the PI, contracts office and study coordinator Coming soon …

Questions?