CBMTG 0801Moving Forward …

Activation Timeline

Canadian Sites

Projected Accrual

Site Activation

• IRB approval

• Regulatory Documents (Checklist)Centre criteria for myeloablative and RIC HPCTSOP 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 email pdf to: Data Management Office (Vancouver)

Study Procedures – Post HPCT

Immune Reconstitution

QOL, Chronic GVHD Follow-Up & HE

Project Website

http://cbmtg0801.org

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 treatmentActivation of EBV either with symptoms or requiring

treatmentPrimary 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?