Q4-6: Best Response to Cellular Therapy

This section may not fit perfectly to all possible indications for cellular therapy. Select the response that is most applicable to the indication for treatment.

*Best Response and Disease Specific Forms Required (CRF)
If the primary disease reported is Acute Lymphoblastic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL), Hodgkin Lymphoma (HL), Non-Hodgkin Lymphoma (NHL), or Multiple Myeloma (MM) and there is a corresponding disease form, best response is not reported on this form. It will be captured on the corresponding disease form. These questions does not apply and are disabled.

*Best Response and Disease Specific Forms Not Required (TED)
If the indication for this course of cellular therapy does not require the completion of disease-specific forms, refer to the disease-specific manuals to locate the response criteria that should be used when reporting best response.

*Subsequent Infusion and Best Response
If a subsequent cellular therapy was given for disease relapse / progression and the F4000 was made NRQ, the best response prior to the relapse/ progression should be reported.

Question 4: What was the best response to the cellular therapy?

This section collects the data known as “best response to cellular therapy”. The purpose of this section is to report the recipient’s best response to the planned course of cellular therapy. This section applies to both malignant and non-malignant diseases and disorders. If the recipient received a prior HCT, do not report the response to the HCT, a separate evaluation to establish best response after the cellular therapy is required.

*Combined follow up
In scenarios where an HCT was given after a cellular therapy and this form is now being completed based on the subsequent HCT date, this question does not apply and is disabled.

For malignant diseases (including solid tumors), appropriate responses are:

• Continued complete response
• Complete response
• Partial response
• No response
• Not evaluated
• Disease progression

!Continued Complete Remission (CCR)
Continued Complete Remission (CCR) should be reported for all recipients who were already in CR at the start of the preparative regimen.

*Reporting Complete Remission (CR) Post-Infusion
Complete remission (CR) criteria vary by disease and are outlined in the CIBMTR Forms Instructions Manual. Refer to the appropriate disease response criteria section of the Forms Instructions Manual and review the criteria to report CR.

If the recipient relapses / progresses post-infusion and receives therapy for the disease relapse / progression, the response to that additional therapy should not be reported in this section. The best response prior to the relapse/ progression should be reported.

For non-malignant disorders, appropriate responses are:

• Normalization of organ function
• Partial normalization of organ function
• No response
• Not evaluated
• Worsening of organ function

If the indication is infection treatment, GVHD treatment or suboptimal donor chimerism, the appropriate responses are:

• Complete response
• Partial response
• No response

Table 1. Examples of best response to cellular therapy.

Indication	Applicable response options	Partial Response	Complete Response
GVHD prophylaxis (with HCT)	Do not answer best response	-	-
GVHD treatment (post-HCT)	Complete Response, Partial Response, or No Response	Improvement but not resolution of symptoms, Remains on immune suppression	Resolution of symptoms and off immune suppression
Immune Reconstitution (post-HCT)	Complete Response or No Response	-	CD3 >200/mm3
Infection prophylaxis	Do not answer best response	-	-
Infection treatment	Complete Response, Partial Response, or No Response	Decrease in infectious burden without resolution	Undetectable infection
Malignant Hematologic Disorder	Continued complete response, Complete Response, Partial Response, Progression, or No Response	Refer to the response criteria as published in the disease specific manual and Table 2 below	Refer to the response criteria as published in the disease specific manual and Table 2 below
Non-Malignant Disorder	Normalization of organ function, Partial normalization of organ function, No response, Worsening of organ function	Persistent Disease	Resolution of Disease Process
Other	Do not answer best response	-	-
Prevent disease relapse	Do not answer best response	-	-
Solid Tumor	Continued complete response, Complete Response, Partial Response, No Response, or Disease Progression	Improvement in disease burden, but with persistent disease	No evidence of disease
Suboptimal donor chimerism (post-HCT)	Complete Response, Partial Response, or No Response	Increase in chimerism but not 100% donor	100% donor chimerism

When reporting best response for myeloma, ALL, or lymphoma, refer to Table 2 to determine the appropriate option to select on the Post-CTED.

Table 2. Disease specific best response

PCD Response Criteria	Select this Option	ALL Response Criteria	Select this Option	LYM Response Criteria	Select this Option
sCR	CR	CR	CR	CR	CR
CR	CR	CRi	CR	PR	PR
VGPR	PR	PIF	Disease progression	SD	NR
PR	PR			PD	Disease progression
SD	NR
PD	Disease progression

Question 5: Was the date of best response previously reported?

Indicate whether date of best response was reported in a previous reporting period.

Do not report Yes if completing this form for the Day 100 reporting period.

*Combined follow up
If the recipient receives an HCT after a cellular therapy and the best response to the cellular therapy was previously reported, it can no longer be evaluated once a recipient has a subsequent HCT. It is appropriate to report Yes for this scenario on the Day 100 report.

Question 6: Date response established

Report the first date when the date of best response was achieved. This should be the first date all criteria were met.

For more information regarding reporting partial or unknown dates, see 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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