Inotuzumab Ozogamicin Supplemental pre-HCT Data Collection Form, Form 2541, must be completed for recipients who are enrolled onto CIBMTR study SC17-10. The study will evaluate safety outcomes post-HCT in patients with B-cell precursor ALL who have been treated with Inotuzumab Ozogamicin prior to proceeding to HCT. The study will utilize all relevant data available in the CIBMTR database from US transplant centers for a 5-year period post-HCT. The study is applicable after the approval of Inotuzumab Ozogamicin in the US.
This supplemental data form, Form 2541, will come due for participating centers when Inotuzumab Ozogamicin is reported on the Recipient Eligibility Form, Form 2500.
Sections of the Forms Instruction Manual are frequently updated. The most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.
|5/8/20||2541: Inotuzumab Ozogamacin (Besponsa™) Supplemental Data||Modify||Updated units of measure for Questions 7-8 verbiage to “m/m 2”.|
|1/14/20||2541: Inotuzumab Ozogamacin (Besponsa™) Supplemental Data||Add||Version 1 of the 2541: Inotuzumab Ozogamacin (Besponsa™) Supplemental Data Collection section of the Forms Instruction Manual released. Version 1 corresponds to revision 2 of the Form 2541.|
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