The Acute Myelogenous Leukemia Pre-Infusion Data Form (Form 2010) is one of the Comprehensive Report Forms. This form captures AML-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 Myelogenous Leukemia (AML or ANLL). Additional disease insert forms will be required if the recipient had Myelodysplastic / Myeloproliferative Syndrome (MDS / MPS), Aplastic Anemia, Fanconi Anemia, or Juvenile Myelomonocytic Leukemia (JMML) prior to their diagnosis of Acute Myelogenous Leukemia. 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).
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 AML); 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 32.
Q1-13: Disease Assessment at Diagnosis
Q14-31: Laboratory Studies at Diagnosis
Q32-68: Pre-HCT or Pre-Infusion Therapy
Q69-96: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion
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||2010: AML Pre-Infusion||Add|| Instructions added above question 32 to provide clarification how to report lines of therapy for a subsequent infusion: Lines of Therapy and Subsequent Infusions
If this is a subsequent infusion and 2010 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2010. Please report from post previous infusion to time of preparative regimen / infusion for the current infusion. If a 2010 was not previously completed, all lines of therapy from diagnosis to the current preparative regimen / infusion must be completed.
|8/24/2020||2010: AML Pre-Infusion||Add||Instructions added to question 58 on how to report the MRD status when the recipient was negative for MRD prior to therapy completion but MRD testing was not repeated after therapy ended: 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 AML, report “No” for question 58. If all MRD testing during this time frame was negative for markers of AML, 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 58. If no MRD testing was performed during this timeframe, leave question 58 blank and override the error in FormsNetSM using the code “Unknown.”|
|8/24/2020||2010: AML Pre-Infusion||Add||Clarification added on how to report sites of relapse when detected in the bone marrow and / or peripheral blood for questions 61 – 68: Report all known sites of active disease at the time of relapse in questions 61-68. This includes any sites identified between the date of relapse reported in question 60 and the time treatment for relapse is initiated. If “Yes” has been reported for “Other site” in question 67, use question 68 to specify all sites of active disease not already reported in questions 61-66. If relapse was detected in the bone marrow and / or peripheral blood, report “Yes” for question 67 and specify these sites in question 68.|
|8/24/2020||2010: AML Pre-Infusion||Add||Instructions added to use the general rules of rounding when reporting the months of therapy in questions 43 – 45: Azacytidine, decitabine, and sorafenib may be given daily rather than in cycles. In order to capture the duration for which these medications are given, centers are asked to report the number of months these drugs were given whenever they have been reported in question 42. If therapy is given greater than a whole month, use the general rules of rounding (i.e., A recipient receives sorafenib twice a day for 13 weeks – specify the months of therapy as “3”).|
|8/24/2020||2010: AML Pre-Infusion||Add|| Clarification added to question 79 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 80.
|2/19/2020||2010: AML Pre-Infusion||Modify||Updated 69 to 32 on 2010: AML Pre-Infusion main page (current page).|
|8/10/18||2010: AML Pre-Infusion||Add||Added the following instruction for questions 72 – 74: If a differential was performed and there were no blasts present in the peripheral blood, the laboratory report may not display a column for blasts. In this case, it can be assumed that no blasts were present and “0” can be reported on the form.|
|11/21/17||2010: AML Pre-Infusion Data||Modify|| Corrected incorrect instruction provided for questions 6-9. The form asks for cytotoxic therapy; however, the manual incorrectly instructed centers to report any systemic therapies.
|7/25/17||2010: AML Pre-Infusion Data||Modify||Version 3 of the 2010: AML Pre-Infusion Data section of the Forms Instructions Manual released. Version 3 corresponds to revision 4 of the Form 2010.|
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