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Research Protocols Being Reviewed Under 45 CFR 46.407
A Phase III Randomized Trial of G-CSF Stimulated Bone Marrow vs. Conventional Bone Marrow as a Stem Cell Source In Matched Sibling Donor Transplantation
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Requesting IRB:
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Nemours Oncology IRB, Nemours Foundation, Jacksonville, Florida
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Study Summary:
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This research protocol is a Phase III trial that proposes to compare two graft sources for children undergoing bone marrow transplantation for leukemia. The bone marrow will be harvested from healthy matched sibling donors. Sibling donors in the experimental group will receive filgrastim (G-CSF) for five days before the harvesting procedure; sibling donors in the control group will only undergo a standard bone marrow harvest.
The study uses a prospective, randomized design for 415 donor-subjects and 415 patient-subjects, with patient-subject assessments at 1, 6, and 12 months (with possible yearly monitoring for 10 years).
The major hypothesis is that the filgrastim-stimulated bone marrow will improve event-free survival. The major study endpoints are treatment-related mortality at 100 days, rates of graft failure, and rates of graft versus host disease.
The protocol includes two optional companion studies:
- "RD Safe" to evaluate short- and long-term risks to donors
- A biology study to assess cellular immune response and store the subjects' blood for future unspecific research
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Funding Source:
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National Cancer Institute, National Institutes of Health
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Documents Related to this Review under 45 CFR 46.407 and 21 CFR 50.54:
(Note: For any person requiring amelioration of documents linked to this page, hard copy versions of the documents may be obtained by making a request to Edward E. Bartlett, Ph.D., at 240-453-8249, or edward.bartlett@hhs.gov. Documents may also be accessed at the Food and Drug Administration Web site at http://www.fda.gov/ohrms/dockets/ac/oc08.html#pac.)
Agendas
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Final Pediatric Ethics Subcommittee Agenda, December 9, 2008 (pdf)
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Final Pediatric Advisory Committee Agenda, December 9, 2008 (pdf)
Slides
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Slides for Pediatric Ethics Subcommittee, December 9, 2008 (pdf)
Federal Register Notices
- Meeting notice for FDA's Pediatric Ethics Subcommittee of the Pediatric Advisory Committee (html, pdf)
- Meeting notice for FDA's Pediatric Advisory Committee (html, pdf)
Protocol Documents
- ASCT0631 Protocol — December 31, 2007 (pdf)
- Correspondence from the COG CIRB — March 25, 2008,
with text of NCI Pediatric Central IRB Approval Pending Modification - November 8, 2006 (pdf)
Parental Permission and Child Assent Documents
- ASCT0631 Parental Permission Recipient (pdf)
- ASCT0631 Parental Permission Sibling Donor (pdf)
- ASCT0631 Donor Assent 7-11yo (pdf)
- ASCT0631 Donor Assent 12-17yo (pdf)
- ASCT0631 Recipient Assent 7-11yo (pdf)
- ASCT0631 Recipient Assent 12-17yo (pdf)
IRB Review Documents
- Nemours Oncology IRB Minutes - July 2 2008 (pdf)
- Stipulation Rebuttal Letter ASCT0631 — July 11, 2008(pdf)
- Nemours Oncology IRB Minutes - September 3, 2008 (pdf)
- ASCT0631 - 407-55 Cover Letter Requesting Secretarial Review - October 1, 2008 (pdf)
Documents Submitted By Sponsor (NCI)
- ASCT0631 Cover Letter from NIH - November 18, 2008 (pdf)
- ASCT0631 Initial Review by NCI Pediatric Central IRB Approval Pending Modification — November 8, 2006 (pdf)
- ASCT0631 risk benefit appendix (pdf)
- BIOETHICS consult - January 2006 G-CSF Study (pdf)
- OHRP Response re Sibling Benefit - January 23, 2006 (pdf)
Supporting Literature Bibliography Document
- Supporting Literature Bibliography Document (pdf)
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