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).
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
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.
|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:
|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
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 “
|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
|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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