Q25-31: Disease Relapse or Progression

*Questions 25-26 are applicate for malignant diseases that do not generate a disease specific form (e.g., AML, CML, MDS, MPN) and for the following products reported in Q1: Letetresgene autoleucel, Other product, or No product name.

Question 25-26: Was a disease relapse or progression detected since the date of last report?

Disease relapse or progression can be documented by a variety of methods including molecular, flow cytometry, cytogenetic/fluorescent in situ hybridization (FISH), radiographic or hematological/clinical. Report Yes if disease relapse or progression was detected by any one of the methods in the current reporting period and report the first date (YYYY-MM-DD) of the relapse or progression detected.

If a disease relapse or progression was not detected in the current reporting period, report No and continue with question 27.

Question 27: Was there evidence of antigen escape?

Many cellular therapies are designed to target a specific tumor antigen(s). One mechanism of resistance to these cellular therapies includes antigen escape. This is when the tumor develops partial or complete loss of the tumor antigen. An example is a recipient with acute lymphoblastic leukemia (ALL) that expresses the CD19 antigen prior to cellular therapy infusion. The patient is given a CD19-directed CAR T-cell therapy and at the time of relapse their leukemia cells no longer express CD19. This may be determined by testing on the blood and/or bone marrow showing absence of the tumor antigen targeted by the cellular therapy they received.

Report Yes if there was evidence of antigen escapes and continue with question 28.

If there was no evidence of antigen escapes in the current reporting period, report No and continue with question 32.

Question 28 – 29: Method of detection of antigen escape (check all that apply)

Methods of detecting antigen escape include Flow cytometry, Immunohistochemistry (IHC) or Other method. Select the method(s) used to detect antigen escape. If Other method is selected, specify what method was used in question 29.

Question 30: Was documentation submitted to CIBMTR?

Indicate whether documentation of the antigen escape was submitted to CIBMTR (e.g., pathology report, autopsy report).
For further instructions on how to attach documents in FormsNet3SM, refer to the Formsnet3 Training Guide.

Question 31: Date of antigen escape

Report the date (YYYY – MM- DD) when testing first showed evidence of antigen escape.

Section Updates:

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