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.

Question 9: 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.

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
GVHD prophylaxis (with HCT) Do not answer best response - -
Prevent disease relapse Do not answer best response - -
Infection prophylaxis Do not answer best response - -
Suboptimal donor chimerism (post-HCT) Complete Response, Partial Response, or No Response Increase in chimerism but not 100% donor 100% donor chimerism
Immune Reconstitution (post-HCT) Complete Response or No Response - CD3 >200/mm3
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
Malignant Hematologic Disorder 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 Complete Response, Partial Response, or No Response Persistent Disease Resolution of Disease Process
Solid Tumor Complete Response, Partial Response, No Response, or Disease Progression Improvement in disease burden, but with persistent disease No evidence of disease
Cardiovascular Disease, Musculoskeletal Disorder, Neurologic Disease, Ocular Disease, Pulmonary Disease Do not answer best response =. – =. –
Infection treatment Complete Response, Partial Response, No Response, or Unknown Decrease in infectious burden without resolution Undetectable infection
Other Do not answer best response - -

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 10-11: Was the date of best response previously reported?

If the date of best response was previously reported, select Yes and continue with question 12. This option is not applicable on the 100 day report.

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) in question 11. 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)
. . . . .
Last modified: Jan 22, 2021

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