This form must be completed for all recipients randomized to the Comprehensive Report Form (CRF) track whose primary disease is reported on the Pre-TED Disease Classification Form (Form 2402) as Non-Hodgkin lymphoma and the subtype is reported as Waldenström’s Macroglobulinemia/Lymphoplasmacytic Lymphoma. The Waldenström’s Macroglobulinemia/Lymphoplasmacytic Lymphoma Post-HCT Data (Form 2119) must be completed in conjunction with each Post-HCT follow-up form (Forms 2100, 2200, 2300) completed. The form is designed to capture specific data occurring within the timeframe of each reporting period (i.e., between day 0 and day 100 for Form 2100, between day 100 and the six-month date of contact for Form 2200, between the date of contact for the six-month follow-up and the date of contact for the one-year follow-up for Form 2200, etc.).
Q1-17: Disease Assessment at the Time of Best Response to HCT
Q18-58: Post-HCT Therapy
Q59-77: Laboratory Studies at the Time of Evaluation for this Reporting Period
Q78-79: 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)|
|5/29/15||2119: WM Post-HCT||Modify|| Clarified explanatory text for questions 22-23:
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