The Acute Lymphoblastic Leukemia Pre-Infusion Data Form (Form 2011) is one of the Comprehensive Report Forms. This form captures ALL-specific pre-infusion data such as: the recipient’s hematologic findings at the time of diagnosis and prior to the start of the preparative regimen, pre-HCT treatments administered and the best response to each line of therapy.
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).
Is this the report of a second or subsequent transplant or cellular therapy for the same disease?
Report “no” and go to question 1 in any of the following scenarios:
- this is the first infusion reported to the CIBMTR;
- this is a second or subsequent transplant for a different disease (e.g., patient was previously transplanted for a disease other than ALL); or
- this is a second or subsequent infusion for the and this (e.g., patient was on TED track for the prior infusion, prior infusion was autologous with no consent, etc.).
If this is a report of a second or subsequent infusion for the and this , report “yes” and go to question 20.
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.
|10/7/2020||2011: ALL Pre-Infusion||Add|| Clarification added to question 20 to explain how to report lines of therapy for a subsequent infusion: Lines of Therapy and Subsequent Infusions
If this is a subsequent infusion and a 2011 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2011. Please report from post previous infusion to time of preparative regimen / infusion for the current infusion. If a 2011 was not previously completed, all lines of therapy from diagnosis to the current preparative regimen / infusion must be completed.
|8/24/2020||2011: ALL Pre-Infusion||Add||Clarification added to question 52 on how to report the MRD status was the recipient was MRD negative prior to therapy completion but not retested: If any MRD testing was performed following the line of therapy being reported, answer question 58 based on the results of the testing performed within 30 days after the date therapy was stopped and prior to any new therapy being initiated. If any MRD testing during this timeframe was positive for markers of ALL, report “No” for question 58. If all MRD testing during this time frame was negative for markers of ALL, report “Yes” for question 58. If the recipient was MRD negative prior to therapy completion and not retested after therapy ended, report “Yes” for question 52.|
|8/24/2020||2011: ALL Pre-Infusion||Add||Instructions provided on how to report bone marrow and peripheral blood as sites of relapse in questions 55 – 63: Report all known sites of active disease at the time of relapse in questions 55-63. This includes any sites identified between the date of relapse reported in question 54 and the time treatment for relapse is initiated. If “Yes” has been reported for “Other site” in question 62, use question 63 to specify all sites of active disease not already reported in questions 55-61. If relapse was detected via bone marrow and / or peripheral blood, report “Yes” for question 62 and specify these sites in question 63.|
|8/24/2020||2011: ALL Pre-Infusion||Add|| Clarification added to question 73 on when to use the “unknown” option: Indicate whether flow cytometry (immunophenotyping) was performed on the blood and / or bone marrow at the last evaluation prior to the start of the preparative regimen / infusion. If “Yes,” go to question 74.
|7/6/2020||2011: ALL Pre-Infusion||Add||Provided clarification on how to answer question 10 for recipients with precursor T-cell and/or precursor B-cell lymphoblastic lymphoma (or lymphoma / leukemia): If the primary disease for infusion is precursor T-cell and/or precursor B-cell lymphoblastic lymphoma (or lymphoma / leukemia), report “No” for question 10 and continue with question 20.|
|2/19/2020||2011: ALL Pre-Infusion||Modify||Updated number from 64 to 20 on ALL Pre-Infusion main page (current page).|
|10/17/18||2011: ALL Pre-Infusion Data||Modify|| Modified (red text was added, struck out text was deleted) the instructional text for questions 37-38:
Treatments vary based on protocol. A treatment may consist of a single drug or a combination of drugs. Additionally, the drugs may be administered on one day, over consecutive days, or continuously. If chemotherapy drugs were administered as part of the line of therapy, select the box for ‘chemotherapy’. You do not need to specify each drug.
|8/31/17||2011: ALL Pre-Infusion Data||Add||Added CNS Prophylaxis Reporting Scenarios A and B located below the instructions for questions 20-26.|
|7/25/17||2011: ALL Pre-Infusion Data||Modify||Version 2 of the 2011: ALL Pre-Infusion Data section of the Forms Instructions Manual released. Version 2 corresponds to revision 5 of the Form 2011.|
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