Transcript Holly Kerr - the CBMTG 0801

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 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 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?