Q1-3: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Question 1: Compared to the disease status prior to the preparative regimen, what was the best response to HCT or cellular therapy since the date of the last report? (Include response to any therapy given for post-HCT maintenance or consolidation, but exclude any therapy given for relapsed, persistent or progressive disease.)

*Nodular Partial Response
Nodular partial response (nPR) is a listed disease status option on the Pre-TED Form (Form 2400 Revision 4), but not on the CLL Pre- and Post-Infusion Data Forms (Form 2013 and 2113). If the disease status meets the criteria for nPR, report the disease status as partial response (PR) on Forms 2013 (Revision 3) and 2113.

The intent of this question is to determine the best overall response to HCT / cellular therapy. This is assessed in each reporting period. When evaluating the best response, determine the disease status within the reporting period using the international working group criteria provided in the in CLL Response Criteria of the Forms Instructions Manual. Compare this response to all previous post-infusion reporting periods. If the response in the current reporting period is the best response to date, report the disease status established within this reporting period. If a better response was established in a previous reporting period, report the previously established disease status. See question 2 to indicate that this disease status was previously reported.

Include response to any post-infusion treatment planned as of Day 0. If post-infusion therapy is given as prophylaxis or maintenance for recipients in CR or as preemptive therapy for recipients with minimal residual disease, consider this “planned therapy,” even if this was not documented prior to the transplant. Do not include response to any treatment administered as a result of relapse, progression, or persistent disease. If a recipient has started treatment for relapse, progression, or persistent disease, report the best response confirmed prior to the initiation of treatment (even if this was confirmed in a prior reporting period).

Question 2: Was the date of best response previously reported?

If the best response to HCT or cellular therapy was first documented during the current reporting period, report “no” and continue with question 3. If the best response was already documented during a prior reporting period, report “yes” and skip questions 3-26.

Do not report “yes” if completing this form for the 100 Day reporting period.

Question 3: Date assessed

Report the date the best response to HCT or cellular therapy was established. This should be the earliest date when all international working group criteria for the response being reported in question 1 were met. Report the date the sample was collected for pathologic evaluation (e.g., bone marrow biopsy) or blood/serum assessment (e.g., CBC, peripheral blood smear). If no pathologic, radiographic, or laboratory assessments were performed to establish the best response, report the office visit in which the physician clinically evaluated the response to HCT or cellular therapy.

If the exact date is not known, use the process described for reporting partial or unknown dates in General Instructions, General Guidelines for Completing Forms.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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