Q67 – 73: First Relapse or Progression Post-Infusion

!Malignant Diseases Only
Only complete the relapse or progression post-infusion questions if the infusion being reported was given to treat a malignant disease. If the infusion being reported was given to treat a non-malignant disease, leave these questions blank. Intervention for relapsed, persistent, or progressive disease questions must be completed regardless of disease type. FormsNet3^SM should enable / disable this section based on the primary disease reported on the Disease Classification (2402) Form. Contact CIBMTR Center Support if it is believed FormsNet3SM is incorrectly enabling / disabling these fields.

*Combined Follow-Up
In scenarios where a cell therapy was given after an HCT and this form is now being completed based on the subsequent cell therapy date, these questions do not apply and are disabled. This information will captured on the corresponding disease-specific form, if applicable.

*Prior Post-Infusion Relapse or Progression
If relapse or progression by any method of assessment (molecular, flow cytometry, cytogenetics, radiological, and / or clinical / hematologic) occurred in a prior reporting period and in a subsequent reporting period, relapse / progression was detected again by the same assessment or by a new assessment, Previously reported should always be reported.

!Relapse and Progression
Relapse and progression by clinical / hematologic and radiologic methods can only be reported if the International Working Group relapse and / or progression criteria were met as noted in the disease-specific manuals.

Questions 67 – 68: Did the recipient experience a relapse or progression by any method(s) of assessment post-infusion?

The intent of this question is to capture the first instance of relapse or progression by any method of assessment. Report if the recipient experienced their first relapse or progression by any method (molecular, flow cytometry, cytogenetic, radiological, or clinical / hematologic) post-infusion.

If Yes, select all methods of relapse and / or progression detection in the reporting period

If the recipient never experienced a post-infusion relapse or progression by any method in the reporting period, select No.

If the first relapse or progression (by any method) occurred in a previous reporting period, select Previously reported.

See below for definitions and examples of each method of detection:

• Molecular: Molecular assessment involves determining whether a molecular marker for the disease exists in the blood or bone marrow. Molecular assessment is the most sensitive method of detection and can indicate known genetic abnormalities associated with the disease for which the HCT was performed. Molecular assessments include polymerase chain reaction (PCR) amplification to detect single specific disease markers, Sanger sequencing, and next generation sequencing. This option should also be selected if the recipient relapsed / progressed by ClonoSEQ®.
• Flow cytometry: Flow cytometry is a technique that can be performed on blood, marrow, or tissue preparations where the cell surface markers can be quantified on cellular material. This allows for the detection of abnormal cell populations for some diseases. Flow cytometry may also be referred to as immunophenotyping.
• Cytogenetic: Cytogenetic studies involve the study of chromosomes, typically through one of two methods: karyotyping or fluorescence in situ hybridization (FISH). Blood, bone marrow, or tissue preparations may be tested by either of these two methods. Karyotyping is both less sensitive and less specific than FISH testing; FISH studies identify only abnormalities detectable by the employed probe set and cannot provide information about the presence or absence of chromosomal abnormalities or markers outside the specific probe set utilized.
• *Radiologic *: Radiologic assessments are imaging techniques used to assess disease response. Imaging techniques used to evaluate disease response typically include PET, CT, or MIBG, but may include x-ray, skeletal survey, or ultrasound in some cases.
• Clinical / hematologic: Clinical / hematologic assessment is the least sensitive method of disease detection. Examples include circulating blasts in the bloodstream for AML, or enlargement of a malignant mass for lymphoma or a solid tumor. Every recipient who has an evaluation by a physician has a “clinical” assessment. Examples of clinical/hematologic assessments include bone marrow biopsy / morphologic evaluation, complete blood count, serum protein electrophoresis, etc.
  

Questions 69 – 73: First date of relapse or progression

For each method of assessment that detected a relapse or progression in the reporting period, report the assessment date. If relapse / progression was detected multiple times by the assessment in the reporting period, report the first assessment detecting relapse / progression.

If the exact date is not known, refer to General Instructions, General Guidelines for Completing Forms, for information about reporting partial or unknown dates.

Section Updates:

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