The Chronic Lymphocytic Leukemia Pre-Infusion Data Form is one of the Comprehensive Report Forms. This form captures CLL-specific pre-infusion data such as: disease assessment at diagnosis, laboratory studies at diagnosis, pre-infusion treatment for CLL, most recent disease assessment prior to the start of the preparative regimen, laboratory studies prior to the preparative regimen or cellular therapy, and disease status at the last assessment prior to the preparative regimen or cellular therapy.
This form must be completed for all recipients assigned to the CRF track whose disease, reported on Pre-TED Disease Classification Form (Form 2402), is chronic lymphocytic leukemia (CLL), B-cell/small lymphocytic leukemia (SLL), or prolymphocytic leukemia (PLL). Both Form 2013 (Chronic Lymphocytic Leukemia Pre-Infusion Data) and Form 2018 (Hodgkin and Non-Hodgkin Lymphoma Pre-Infusion Data), must be completed if the recipient had a Richter’s transformation from CLL to diffuse large B-cell lymphoma prior to transplant or cellular therapy.
If this is a report of a second or subsequent transplant for the same disease subtype and this baseline disease insert was not completed for the previous transplant (e.g., patient was on TED track for the prior HCT, prior HCT was autologous with no consent, etc.), begin at question 1.
If this is a report of a second or subsequent transplant for a different disease (e.g., patient was previously transplanted for a disease other than CLL), begin the form at question 1.
If this is a report of a second or subsequent transplant for the same disease and this baseline disease insert has previously been completed, check the indicator box and continue with question 149.
Q1-21: Disease Assessment at Diagnosis
Q22-73: Laboratory Studies at Diagnosis
Q74-148: Pre-HCT or Pre-Infusion Therapy
Q149-191: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen
Q192-193: Disease Status at the Last Assessment Prior to the Preparative Regimen
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.
|2/28/2022||2013: CLL Pre-Infusion||Modify||Instructions updated for question 52 to clarify timepoint: Flow cytometry (immunophenotyping) is a technique that can be performed on blood, bone marrow, or tissue preparations where cell surface markers can be detected on cellular material. If flow cytometry (immunophenotyping) was performed at the time of diagnosis or prior to the start of therapy, report “yes” and continue with question 53. If not, report “no” and skip questions 53-60.|
|2/28/2022||2013: CLL Pre-Infusion||Modify|| Instructions for question 40 updated to clarify timepoint: Indicate the leukemic cell type as either B-cell or T-cell. Cell type can be determined using immunophenotyping techniques such as flow cytometry and
|10/7/2020||2013: CLL Pre-Infusion||Add|| Clarification added to question 74 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 2013 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2013. Please report from post previous infusion to time of preparative regimen / infusion for the current infusion. If a 2013 was not previously completed, all lines of therapy from diagnosis to the current preparative regimen / infusion must be completed.
|2/24/17||Comprehensive Disease-Specific Manuals||Modify||Updated explanations of triggers for disease inserts to refer to the primary disease reported on the Pre-TED Disease Classification Form (Form 2402) instead of the Pre-TED Form (Form 2400)|
|12/12/2016||2013: CLL Pre-Infusion||Modify||Instructions for Revision 2 of the CLL Pre- and Post-HCT Forms were retired and instructions for Revision 3 of the CLL Pre- and Post-Infusion Forms were released.|
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