2110: AML Post-Infusion

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).

Links to Sections of Form
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

Manual Updates:
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.

If you need to reference the historical Manual Change History for this form, please click here or reference the retired manual section on the Retired Forms Manuals.

Date	Manual Section	Add/Remove/Modify	Description
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: Disease was detected by any method in the reporting period (reported in the Disease Detection Since the Date of Last report, questions 51 – 89) and no therapy was given to treat disease between the date(s) of the assessments reported in the Disease Detection Since the Date of Last Report (questions 51-58) for the form and the date of contact for this reporting period Disease was detected by any method in the reporting period (reported in the Disease Detection Since the Date of Last Report, questions 51 – 89), therapy was administered, but no assessments were performed after the initiation of therapy if the most recent disease assessments have already been reported in questions 51-89. Also, report “Yes” for question 104 and go to question 144 if assessments were reported in questions 51-89 and no therapy was given to treat disease between the date(s) of the reported assessments and the date of the contact for this reporting period Report “No” for question 104 and report the most recent disease assessments in the reporting period in questions in 105 – 143 in any of the following scenarios: Disease was not detected by any method of assessment during the reporting period Disease was detected in the reporting period (reported in the Disease Detected Since the Date of Last Report, questions 51 – 89), therapy was administered, and additional assessment(s) were performed after therapy by at least one method of assessment during the reporting period (reported in questions 51-89), but the most recent assessments have not yet been reported on the form In addition, the graphic and example E were added.
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 occurred detected the recipient’s primary disease during the reporting period, report “Yes” for question 51 and report the date the sample was collected in question 52. 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 “No Unknown” go to question 63.
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 If testing by a particular method for molecular or cytogenetic markers / abnormalities was not done during the reporting period or it is not known whether testing was performed, report “Unknown” for that method those methods (question 51 and 70). If testing by flow cytometry, clinical / hematologic assessment, or other assessment was not done during the reporting period or it is not known whether testing was performed, report “No” for those methods (questions 63, 80, and 87).
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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