Substantive changes to the MOP are detailed below:
 

CHAPTER 1 - STUDY ORGANIZATION

• Exhibit 1-1 COBLT Study Participating Units - Added new transplant centers to the list.
• Section 1.2.2.2 DSMB Membership - Deleted the membership list.
• Section 1.2.5 Technical Subcommittees - Updated the membership lists of various subcommittees. Added new subcommittee.

CHAPTER 8 - COBLT CORD BLOOD BANK SEARCH PROCEDURES - Revised search procedures to describe searching using the COBLT online search system.

CHAPTER 10 - DATA COLLECTION

• Section 10.2.6 Hematopoiesis Assessment - Red Cells - Updated form and instructions with checkbox for previous submission of patient engraftment data.
• Section 10.2.7 Specimen Submission - Immune Reconstitution - Updated form and instructions requesting date of most recent tetanus immunization.
• Section 10.2.2B CBU Infusion - Updated form and instructions with revised reporting time.
• Section 10.2.10 Relapse Form - Updated form and instructions requesting data on molecular examination of blood and bone marrow post-transplant, lymphoblastic Non-Hodgkin's Lymphoma, and percentage of Leukemic blasts.
• Section 10.2.11 Adverse Experience Form - Added question regarding reporting of adverse experiences to the IRB.

APPENDIX A - ROSTER - Roster has been updated.

APPENDIX B - INVESTIGATORS BROCHURE - Revised instructions for centrifuging cord blood cells.

UPDATED FORMS

• Hematopoiesis Assessment Form - Red Cells (V03, 02/03)
• Specimen Submission Form (V03, 03/03)
• Relapse Form (V03, 10/02)
• Adverse Experience Form (V02, 06/02)