The Acute Myelogenous Leukemia Post-Infusion Data Form (Form 2110) is one of the Comprehensive Report Forms. This form captures AML-specific post-infusion data such as: the recipient’s best response to HCT or cellular therapy, cytogenetic and molecular findings at the time of best response, post-infusion therapy for AML, assessment and treatment of relapse, and current disease assessments.
This form must be completed for all recipients randomized to the Comprehensive Report Form (CRF) track whose primary disease is reported on Disease Classification Form (Form 2402), as Acute Myelogenous Leukemia (AML or ANLL). This form must also be completed if the recipient received a cellular therapy to treat AML as reported on the Pre-CTED Form (Form 4000).
Q1-40: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy
Q41-50: Post-HCT / Post-Infusion Therapy
Q51-103: Disease Detection Since the Date of Last Report
Q104-144: Disease Status at the Time of Evaluation for This Reporting Period
Sections of the Forms Instruction Manual are frequently updated. In addition to documenting the changes within each manual section, the most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.
|10/5/2020||2110: AML Post-Infusion||Add|| Further clarification added on when to answer “yes” and “no” for Q104: Report “Yes” for question 104 and go to question 144 in any of the following scenarios:
|2/21/2020||2110: AML Post-Infusion||Modify||Modified question 51-52 in the Disease Detection Since Date of Last Report section.|
|3/19/18||Comprehensive Disease Specific Manuals||Add|| Added the following instruction for applicable post-infusion disease-specific forms where current disease status is asked (2110, 2111, 2112, 2113, 2114, 2115, 2116, 2118, 2119).
The center does not need to repeat all disease-specific assessments (biopsies, scans, labs) each reporting period in order to complete current disease status data fields. Once a particular disease status is achieved, the center can continue reporting that disease status (based on labs / clinical assessments) until there is evidence of relapse / progression.
|2/22/18||2110: AML Post-Infusion Data||Modify|| Added (in red) and removed (struck out) text from instructions for questions 51-52.
If any testing for molecular markers
If molecular marker testing did not detect disease at any time during the reporting period, report “No” for question 51 and go to question 63.
If molecular marker testing was not performed during the reporting period, report “
|2/22/18||2110: AML Post-Infusion Data||Modify|| Added (in red) and removed (struck out) text from the beginning of section Q51-103: Disease Detection Since Date of Last Report
|2/22/18||2110: AML Post-Infusion Data||Add|| Added text (in red) to the Questions 51-103 warning box.
For questions 51, 63, 70, 80, and 87, report “No” or “Unknown” (see instructions below) if the recipient did not relapse, have persistent or minimal residual disease even if testing was performed.
|7/25/17||2110: AML Post-Infusion Data||Modify||Version 3 of the 2110: AML Post-Infusion Data section of the Forms Instructions Manual released. Version 3 corresponds to revision 4 of the Form 2110.|
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