Q12-14: Best Response to Cellular Therapy

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

*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. The question should be left blank and override the error with the override code “Verified Correct (VC)” at this time.

*If the indication for this course of cellular therapy does not require the completion of disease-specific forms, please refer to the disease-specific manuals to locate the response criteria that should be used when reporting best response.

Question 12: 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
If the recipient receives a subsequent HCT, do not report the best response to the HCT here. The reported best response to the cellular therapy was previously reported and can no longer be evaluated once a recipient has a subsequent HCT. Continue to report best response achieved from the cellular therapy.

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

• Continued complete response
• Complete response
• Partial response
• No response
• Disease progression
  

For non-malignant disorders and cardiovascular, musculoskeletal, neurologic, ocular or pulmonary disease, appropriate responses are:

• Normalization of organ function
• Partial normalization of organ function
• No response
• Worsening of organ function
  

If the indication is infection, 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
Cardiovascular Disease, Musculoskeletal Disorder, Neurologic Disease, Ocular Disease, Pulmonary Disease	Do not answer best 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	Improvement but not resolution of symptoms, or Remains on 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	Refer to the response criteria as published in the disease specific manual
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

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.

Question 13-14: Was the date of best response previously reported?

If the best response to cellular therapy was first documented during the current reporting period, report No. If the best response was achieved during a previous reporting period (and therefore reported on a previous post-CTED form), report Yes.

Do not report Yes if completing this form for the 100 day 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 100 day report.

If the date of best response has not been reported, select No and report the date (YYYY-MM-DD). The date of best response should be the first date all criteria were met.

If the exact date is unknown, please view General Instructions, General Guidelines for Completing Forms for more information on reporting partial and unknown dates.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
12	1/19/4	Add	Added text in red to the first blue box above question 12: 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.	Additional clarification for TED level reporting.

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