2111: ALL Post-Infusion

The Acute Lymphoblastic Leukemia Post-Infusion Data Form (Form 2111) is one of the Comprehensive Report Forms. This form captures ALL-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 ALL, 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 Lymphoblastic Leukemia (ALL). This form must also be completed if the recipient received a cellular therapy to treat ALL as reported on the Pre-CTED Form (Form 4000).

Links to Sections of Form
Q1-34: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy
Q35-47: Post-HCT / Post-Infusion Therapy
Q48-94: Disease Detection Since the Date of Last Report
Q95-130: Disease Status at the Time of Evaluation for This Reporting Period

Manual Updates:
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.
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 webpage.

Date	Manual Section	Add/Remove/Modify	Description
10/5/20	ALL Post-Infusion	Add	Clarification added on when to report “yes” and “no” to question 95: Report “Yes” for question 95 and go to question 129 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 48-80) and no therapy was given to treat diseases between the date(s) of the assessments reported in the Disease Detection Since the Date of Last Report (questions 48-80) 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 48-80), 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 48-80. Also, report “Yes” for question 95 and go to question 129 if assessments were reported in questions 48-80 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 the question 95 and %(color-red)report the most recent disease assessments in the reporting period in questions 96 – 128 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 48 – 80), 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 48-80), but the most recent assessments have not yet been reported on the form In addition, the graphic and example E were added.
3/5/20	ALL Post-Infusion	Add	In section Disease Assessment at the Time of Best Response to HCT, guidance for question 1 on scenarios where 2111 is completed for both the cellular therapy and HCT track.
2/19/20	ALL Post-Infusion	Add	In section Disease Assessment at the Time of Best Response to HCT, added scenarios in introduction for instances when form is completed for both the cellular therapy track and HCT track.
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	2111: ALL Post-Infusion Data	Modify	Added (in red) and removed (struck out) text from instructions for questions 48-49. If any testing for molecular markers occurred detected the recipient’s primary disease during the reporting period, report “Yes” for question 48 and report the date the sample was collected in question 49. If molecular marker testing did not detect disease at any time during the reporting period, report “No” for question 48 and go to question 49. If molecular marker testing was not performed during the reporting period, report “No Unknown” go to question 53.
2/22/18	2111: ALL Post-Infusion Data	Modify	Added (in red) and removed (struck out) text from the beginning of section Q48-94: 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 48 and 61). 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 54, 71, and 78).
2/22/18	2111: ALL Post-Infusion Data	Add	Added text (in red) to the Questions 48-94 warning box. For questions 48, 54, 61, and 78, 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	2111: ALL Post-Infusion Data	Modify	Version 3 of the 2111: ALL Post-Infusion Data section of the Forms Instructions Manual released. Version 3 corresponds to revision 4 of the Form 2111.

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