The Chronic Lymphocytic Leukemia Post-Infusion Data Form is one of the Comprehensive Report Forms. This form captures CLL-specific post-infusion data such as: disease assessment at the time of best response to HCT or cellular therapy, laboratory studies at the time of best response to HCT or cellular therapy, post-infusion planned treatment for CLL, disease relapse or progression post-infusion, and disease status at the time of assessment for this reporting period. For an overview of CLL, refer to the instructions for the CLL Pre-Infusion Data Form.
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). If the recipient underwent a transformation to diffuse large B-cell lymphoma (Richter’s transformation), only the CLL Pre-Infusion Data Form (Form 2013) must be completed. Do not complete a CLL Post-Infusion Data Form (Form 2113).
The Chronic Lymphocytic Leukemia Post-Infusion Data (Form 2113) must be completed in conjunction with each Post-Infusion Data Follow-up Form. The form is designed to capture specific data occurring within the timeframe of each reporting period (i.e., between day 0 and day 100, between day 100 and the six-month date of contact, between the date of contact for the six-month follow-up Form 2200 and one-year date of contact, etc.).
Q1-3: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy
Q4-26: Disease Assessment at Time of Best Response
Q27-42: Post-HCT / Post-Infusion Planned Therapy
Q43-88: Disease Relapse or Progression Post-HCT / Post-Infusion
Q89-113: 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.
|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.
|2/24/17||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||2113: CLL Post-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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