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CBMTG 0801 Moving Forward …

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.

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CBMTG 0801 Moving Forward …

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  1. CBMTG 0801Moving Forward …

  2. Activation Timeline

  3. Canadian Sites

  4. Projected Accrual

  5. 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)

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

  7. 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.

  8. 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

  9. 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)

  10. Study Procedures – Post HPCT Immune Reconstitution

  11. QOL, Chronic GVHD Follow-Up & HE

  12. Project Website

  13. http://cbmtg0801.org

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

  15. Study Schedule

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

  17. 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

  18. 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

  19. 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.

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

  21. Questions?

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