Q9 – 33: Graft vs Host Disease

!Autologous Infusions
If this was an autologous infusion, continue with the Liver Toxicity Prophylaxis section of the form. The GVHD section should only be completed for allogeneic infusions.

*GVHD Reporting Instruction Overview
Review the GVHD Reporting Instruction Overview for detailed GVHD reporting instructions and various GVHD reporting scenarios.

*Combined Follow Up
In scenarios where both HCT and cell therapy forms are being completed, GHVD questions are disabled on the Cellular Therapy Essential Data Follow-Up (4100) form and should be answered on the Post-TED (2450).

!Acute GVHD Persisting After Chronic GVHD
If acute GVHD is diagnosed prior to chronic GVHD, report the diagnosis information, maximum severity of any symptoms, and treatment administered up to the date of diagnosis of chronic GVHD in the acute GVHD section of the form. Do not include any signs, symptoms, or treatment occurring on or after the onset of chronic GVHD when completing the acute GVHD section. Report any new or persistent acute GVHD symptoms occurring on or after the onset of chronic GVHD only in the chronic GVHD section. If chronic GVHD was diagnosed in a prior reporting period, report No acute GVHD did not develop or persist in each subsequent reporting period. See reporting scenarios included in the GVHD Reporting Instruction Overview.

Question 9: Did acute GVHD develop?

Indicate whether acute GVHD developed in the reporting period.

The Unknown option should only be used when there is no information about the recipient’s GVHD status for the entire reporting period. This option should be used sparingly and only when no judgement can be made about the presence or absence of GVHD in the reporting period.

For detailed instructions regarding whether a new development of acute GVHD should be captured, review the GVHD Reporting Instruction Overview.

Question 10: Date of acute GVHD diagnosis

Report the date of clinical diagnosis of acute GVHD. The clinical diagnosis date may not necessarily be the date the symptoms began (i.e., the recipient developed a rash one week prior to the physician clinically diagnosing acute skin GVHD). If the clinical diagnosis is documented, but the diagnosis date is unclear, obtain documentation from the primary physician confirming the clinical diagnosis date.

If the recipient developed more than one episode of acute GVHD in the same reporting period, report the diagnosis date of the first episode of acute GVHD.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

!Persistent GVHD and Day 100 Reporting Period
Previously, reporting Yes for Did acute GVHD persist was not an applicable option for the Day 100 reporting period. However, if there was a prior infusion, the recipient developed acute GVHD in the last reporting period of the previous infusion and acute GVHD persisted into the Day 100 reporting period of the current infusion, report Yes, acute GVHD persisted.

Question 11: Did acute GVHD persist?

Indicate if acute GVHD was clinically diagnosed in the previous reporting period and persisted, with active symptoms, into the current reporting period.

The Unknown option should only be used when there is no information about the recipient’s GVHD status for the entire reporting period. This option should be used sparingly and only when no judgement can be made about the presence or absence of GVHD in the reporting period.

Review the GVHD Reporting Instruction Overview for various GVHD reporting examples.

*GVHD Grading and Staging Criteria
The CIBMTR will continue to collect overall grade of acute GVHD data based on the Przepiorka et al. criteria. New methods of grading acute GVHD, such as the MAGIC consortium criteria¹, may be used internally at sites; however, all data reported to the CIBMTR should be consistent with the Przepiorka et al. criteria.

¹ Harris AC, Young R, Devine S, et al. International, Multicenter Standardization of Acute Graft-versus-Host Disease Clinical Data Collection: A Report from the Mount Sinai Acute GVHD International Consortium. Biol Blood Marrow Transplant. 2015;22(1):4–10. doi:10.1016/j.bbmt.2015.09.001

Questions 12 – 18: Overall grade and organ staging of acute GVHD at diagnosis

These questions are intended to capture each organ stage and the overall grade at the time of acute GVHD diagnosis. For reporting purposes, “at diagnosis” is defined as the period between onset of signs / symptoms and the initiation of therapy to treat GVHD (topical or systemic). The acute GVHD grading scale is based on clinical evidence (physician observation), not histology. Pathology reports sometimes list a histologic grade of GVHD. Do not report the histologic grade. GVHD scoring and grading is based on clinical severity, not histological severity. Biopsy of affected organs allows for more precise diagnosis as to the presence or absence of GVHD. However, overall grading remains clinical and is based on the criteria published by Przepiorka et al., Bone Marrow Transplant 1995; 15(6):825-8.

Report the overall grade and organ staging at the diagnosis of acute GVHD. Review the GVHD Reporting Instruction Overview for additional information and on the criteria for each organ staging and grading.

Questions 19 – 20: Maximum overall grade of acute GVHD

These questions are intended to capture the maximum overall grade of acute GVHD within the reporting period.

Report the maximum acute GVHD grade in the reporting period and the first date of the maximum acute GVHD grade based on clinical judgement. If the recipient had multiple instances in which the GVHD reached the same maximum grade, report the earliest date, regardless of any variation in the organ staging.

If chronic GVHD was diagnosed during the reporting period, report the maximum overall grade of acute GVHD prior to the onset of chronic GVHD.

For detailed reporting instructions about reporting the maximum grade and organ staging of acute GVHD, review the GVHD Reporting Instruction Overview.

!Maximum Organ Staging
Due to further clarification provided, the instructions for reporting the maximum organ staging were updated with the Fall 2023 Quarterly Release. The intent of the maximum organ staging questions is to capture the maximum stage of each organ involved with acute GVHD in the reporting period, not at the time of the maximum overall grade.

Questions 21 – 26: Maximum organ stage of acute GVHD

These questions are intended to capture the maximum organ staging within the reporting period.

Report the maximum acute GVHD organ staging in the reporting period, which may not necessarily be at the time when the maximum acute GVHD overall grade occurred, as reported above.

If chronic GVHD was diagnosed during the reporting period, report the maximum organ staging of acute GVHD prior to the onset of chronic GVHD.

For detailed reporting instructions about reporting the maximum grade and organ staging of acute GVHD, review the GVHD Reporting Instruction Overview.

Question 27: Did chronic GVHD develop?

Indicate whether a new clinical diagnosis of chronic GVHD was documented during the
reporting period.

The Unknown option should only be used when there is no information about the recipient’s GVHD status for the entire reporting period. This option should be used sparingly and only when no judgement can be made about the presence or absence of GVHD in the reporting period.

For detailed instructions on whether a new development of chronic GVHD should be captured, review the GVHD Reporting Instruction Overview.

Question 28: Date of chronic GVHD diagnosis

Report the date of clinical diagnosis of chronic GVHD. The clinical diagnosis date may not necessarily be the date the symptoms began (i.e., the recipient developed shortness of breath one month prior to the clinical diagnosis of pulmonary chronic GVHD). If the clinical diagnosis is documented, but the diagnosis date is unclear, obtain documentation from the primary physician confirming the clinical diagnosis date.

If the recipient developed more than one episode of chronic GVHD in the same reporting period, report the diagnosis date of the first episode of chronic GVHD.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

!Persistent GVHD and Day 100 Reporting Period
Previously, reporting Yes for Did chronic GVHD persist was not an applicable option for the Day 100 reporting period. However, if there was a prior infusion, the recipient developed chronic GVHD in the last reporting period of the previous infusion and chronic GVHD persisted into the Day 100 reporting period of the current infusion, report Yes, chronic GVHD persisted.

Question 29: Did chronic GVHD persist?

Indicate if chronic GVHD was clinically diagnosed in the previous reporting period and persisted, with active symptoms, into the current reporting period. Do not report quiescent or inactive chronic GVHD, or a prior history of GVHD. See instructions above on reporting a chronic GVHD flare.

The Unknown option should only be used when there is no information about the recipient’s GVHD status for the entire reporting period. This option should be used sparingly and only when no judgement can be made about the presence or absence of GVHD in the reporting period.

Review the GVHD Reporting Instruction Overview for various GVHD reporting examples.

Question 30: Maximum grade of chronic GVHD (according to best clinical judgement)

Report the maximum chronic GVHD involvement, based on the opinion of the clinician (i.e., clinical grade), since the date of the last report. The intent of this question is to capture the maximum grade based on the best clinical judgment. If both the global severity score and the score based on the clinician’s opinion are documented, report the clinician score. If the maximum clinical grade is not documented, request documentation from the recipient’s primary care provider.

Additional guidelines on reporting the maximum grade of chronic GVHD are outlined in the GVHD Reporting Instruction Overview.

Question 31: Date of maximum grade of chronic GVHD

Report the date of maximum chronic GVHD involvement, based on clinical grade, during the current reporting period. If the recipient had multiple instances in which their GVHD reached the same maximum grade, report the earliest date.

Review the GVHD Reporting Instruction Overview for various GVHD reporting examples.

*Corticosteroids
Corticosteroids are captured differently depending on whether they are used topically or systemically. Use the following guidelines when determining how to report corticosteroids used to treat acute GVHD:
Topical Creams for Skin: Do not report topical ointments or creams used to treat skin GVHD including corticosteroid creams such as Triamcinolone or Hydrocortisone.
Other Topical Treatments: Certain corticosteroid treatments are inhaled or ingested but are not absorbed and are therefore considered topical. Examples include beclomethasone and budesonide. Do not consider these medications when answering the question regarding systemic steroids.
Systemic Treatments: Systemic administration of corticosteroids, including use of prednisone and dexamethasone, should be reported in the question regarding systemic steroids

Question 32 – 33: GVHD treatment

These questions are intended to capture if the recipient was still receiving systemic steroids (steroid dose < 10 mg / day for adults, < 0.1 mg / kg / day for children, excluding steroids for adrenal insufficiency) and non-steroid immunosuppressive agents for GVHD on the contact date.

Indicate if the recipient was still taking systemic steroids (steroid dose < 10 mg / day for adults, < 0.1 mg / kg / day for children, excluding steroids for adrenal insufficiency) and non-steroid immunosuppressive agents on the contact date. Review the GVHD Reporting Instruction Overview for reporting instructions to these questions.

Section Updates:

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