Graft vs. Host Disease (GVHD) is an immunological phenomenon resulting from the reaction of donor immune cells against major or minor histocompatibility antigens of the recipient. GVHD is primarily caused by donor-derived T-cells. Very rarely, GVHD may occur due to autologous reactivity (autologous GVHD), third party transfusions, or with identical twin (syngeneic) transplantation.

Factors influencing the severity of GVHD are related to three main categories: 1) donor or graft, 2) recipient, and 3) treatment. Influential risk factors include the degree of genetic disparity between the donor and the recipient (HLA match), female donor to male recipient, donor parity, older donors, and T-cell dose. The occurrence of acute GVHD becomes a risk factor for the development of chronic GVHD. Recipient age and prior infections are also factors.

In the past, GVHD was classified as acute or chronic based on its time to diagnosis following transplant, and other clinical and histological (biopsy or post-mortem) features. Today, there has been increased recognition that acute and chronic GVHD are not dependent upon the time since HCT, so determination of acute or chronic should rest on clinical and histological features. However, organ staging and overall grade should only be calculated from the clinical picture, not histology. Acute GVHD usually begins between 10 and 40 days after HCT but can appear earlier or later. The organs most commonly affected by acute GVHD are the skin, gut, and / or liver. Other sites, such as the lung, may be involved.

Question 131: Was specific therapy used after the start of the preparative regimen to prevent acute GVHD? (Note: do not include growth factors reported in questions 19-48, or ex vivo T-cell depletion reported on the Product Insert. Do not include drugs given as part of the preparative regimen)

Following an allogeneic HCT, specific immunosuppressive therapy may be administered to prevent GVHD or to immunosuppress the host marrow, thereby promoting engraftment of the donor hematopoietic stem cells. Most transplant centers have specific GVHD prophylaxis protocols and graft rejection protocols. Any agent a recipient receives as a result of these protocols should be included in this section.

The prophylactic drug options listed on the form are intended to be systemic (IV or oral administration). If the recipient received one of the listed drugs in a topical form, report the drug in the “other, specify” category.

Do not include growth factors reported in question 19, or ex vivo T-cell depletion reported on the Product Insert. Do not include drugs given as part of the preparative regimen.

The Post-Transplant Follow-Up Data Form (Form 2100) lists the generic immune suppression drug names. The following website provides the trade names under which generic drugs are manufactured: http://www.rxlist.com/drugs/alpha_a.htm.

If GVHD prophylaxis is used for a syngeneic (monozygotic or identical twin) or autologous HCT, upload documentation in FormsNet3 using the attachment feature. Contact the CIBMTR Center Support with questions.

If specific therapy was given after the start of the preparative regimen to prevent acute GVHD, report “yes” and continue with question 132. See the GVHD Prophylaxis note above for additional instructions on how to report ATG, cyclophosphamide, and alemtuzumab. If specific therapy to prevent acute GVHD was not given after the start of the preparative regimen, report “no” and continue with question 157.

Questions 132-156:

For each agent listed, indicate whether it was used to prevent acute GVHD or graft rejection, and answer any additional question(s) for each prophylactic therapy used.

ALG (Anti-Lymphocyte Globulin), ALS (Anti-Lymphocyte Serum), ATG (Anti-Thymocyte Globulin) ATS (Anti-Thymocyte Serum): Serum or gamma globulin preparations containing polyclonal immunoglobulins directed against lymphocytes. These drugs are usually prepared from animals immunized against human lymphocytes. Also report the animal source. If “other” is selected, specify the source.

Bortezomib (Velcade): A proteasome inhibitor.

Corticosteroids (systemic) (e.g., prednisone, dexamethasone): Usually combined with cyclosporine when used for prophylaxis. Only report systemic steroids in this section. If topical steroids are used prophylactically, report in questions 155-156 and provide an explanation regarding how the site for topical application was selected.

Cyclosporine (CSA, Neoral, Sandimmune): Calcineurin inhibitor which decreases cytokine production by T-cells. Usually given for ≥ 3 months.

Cyclophosphamide (Cytoxan): Given in high doses near the date of infusion as single agent prophylaxis.

Extra-corporeal photopheresis (ECP): The recipient’s blood is removed from the body, exposes to psoralen and ultraviolet light, and re-infused.

FK 506 (Tacrolimus, Prograf): Inhibits the production of interleukin-2 by T-cells.

In vivo monoclonal antibody: Antibody preparations that are infused in the recipient following HSCT. Specify the antibody used as: anti CD25 (Zenapax, Daclizumab, AntiTAC), alemtuzumab (Campath), entanercept (Enbrel), infliximab (Remicade), and / or rituximab (Rituxan).

In vivo immunotoxin: Antibody preparations linked to a toxin that is infused in the recipient following HCT. Specify the immunotoxin.

Methotrexate (MTX) (Amethopterin): Inhibits the metabolism of folic acid. It is most often used with cyclosporine and is usually for a short duration of time.

Mycophenolate mofetil (MMF) (CellCept, Myfortic): Inhibits the de novo pathway used for lymphocyte proliferation and activation.

Sirolimus (Rapamycin, Rapamune): Inhibits the response to interleukin-2, blocking the activation of T-cells.

Blinded randomized trial: If the recipient is on a blinded randomized trial, specify agent being studied in the trial. Additionally, update the Post-HCT Data Form (Form 2100) once the trial is over to specify whether the recipient received the trial drug or placebo.

Other agent: Specify the other agent being given as GVHD prophylaxis.

  • Do not include ex vivo T-cell depletion. Report ex vivo T-cell depletion on the HCT Infusion Form (Form 2006).
  • Do not include agents used to prevent infection. Report infection prophylaxis agents in the infection section, questions 407-427.

Question 157: Did acute GVHD develop since the date of the last report?

Questions 157 and 159 on the Post-HCT Follow-Up Data Form are meant to capture whether the recipient had active symptoms of acute GVHD during the reporting period. If the recipient had active acute GVHD during the reporting period, either question 157 or question 158 must be answered “yes” unless there has been a prior / concurrent diagnosis of chronic GVHD (refer to the note above question 157). There will not be a situation where “yes” is reported for both question 157 and question 159. If question 157 is answered yes and a diagnosis date has been reported in question 158, question 159 will be disabled in FormsNet3SM. Centers should report “yes” for question 157 to indicate the recipient developed acute GVHD in the following scenarios:

  • Acute GVHD is diagnosed for the first time during the reporting period.
  • An acute GVHD flare is diagnosed during the current reporting period and all of the following conditions are met:
    • The recipient’s prior acute GVHD symptoms did not persist from the prior reporting period into the beginning of the current reporting period.
    • The flare is diagnosed after at least 30 days without any active acute GVHD symptoms.
    • The recipient was not diagnosed with chronic GVHD on or before the date of the flare (see note above question 157).

If the recipient does have active acute GVHD during the reporting period, but does not match either of the scenarios above, the center will likely need to report “no” for question 157 and “yes” for question 159. Question 159 is intended to capture acute GVHD which has continued from a prior reporting period. This includes any flares which do not meet the above conditions. The intent of classifying GVHD episodes as newly developed or persistent is to avoid having centers re-report diagnosis information which has been captured on a prior form. Refer to the Acute GVHD Diagnosis Scenarios below to see examples of how to answer questions 157 and 159.

Report “no” for questions 157 and 159 if the recipient had no active acute GVHD symptoms during the reporting period OR all acute GVHD signs / symptoms during the reporting period occurred after a diagnosis of chronic GVHD (see note above question 157).

Indicate “unknown” if there is no information about the recipient’s GVHD status for the reporting period. This option should be used sparingly and only when no judgment can be made about the presence or absence of GVHD in the reporting period.

Acute GVHD Diagnosis Scenarios:

A. A recipient receives a HCT on 1/1/2015 and develops acute GVHD which is clinically diagnosed on 2/1/2015. At least one of their symptoms, attributed to acute GVHD, persists beyond the 100 day date of contact which is 4/5/2015. Treatment continues and symptoms completely resolve on 5/1/2015. Immunosuppression is tapered until a flare of acute GVHD is diagnosed on 5/25/2015. Immunosuppression is given and symptoms quickly resolve with no active acute GVHD beginning 6/10/2015. The six month date of contact is 6/20/2015. Another flare of acute GVHD is clinically diagnosed on 8/15/2015.

100 Day Post-Infusion Data Form:

Question 157: Report “yes” to indicate a new clinical diagnosis of acute GVHD.
Question 158: Report the initial date of diagnosis (2/1/2015).
Question 159: Leave blank. This question will be skipped whenever a diagnosis date has been entered in question 158.
Questions 160-175: Answer these questions based on the assessments performed at the time of diagnosis (2/1/2015).

Six Month Post-Infusion Data Form:

Question 157: Report “no” to indicate acute GVHD persists from a previous report. Note, the flare of acute GVHD was < 30 days from symptoms resolution so it doesn’t count as a new reportable episode.
Question 158: Leave blank. This question will be skipped whenever question 157 is answered “no.”
Question 159: Report “yes” to indicate GVHD persists from a previous report.
Questions 160-175: Leave blank. Answering “yes” for question 159 prevents the center from re-reporting diagnosis information already captured on the 100 day form.

One Year Post-Infusion Data Form:

Question 157: Report “yes” to indicate a flare of acute GVHD occurred at least 30 days after resolving during a prior reporting period.
Question 158: Report the diagnosis date of the flare occurring during the reporting period (8/15/2015).
Question 159: Leave blank. This question will be skipped whenever a diagnosis date has been entered in question 158.
Questions 160-175: Answer these questions based on the assessments performed at the time of diagnosis of the flare of acute GVHD (8/15/2015).

B. A recipient receives a HCT on 1/1/2015 and develops acute skin GVHD on 2/1/2015 and then chronic eye GVHD on 3/1/2015. Both acute and chronic symptoms resolve by the 100 day date of contact (4/5/2015). While tapering their immunosuppression, the recipient has a flare of their acute skin GVHD on 5/30/2015. Treatment continues and symptoms completely resolve by the six month date of contact (6/20/2015).

100 Day Post-Infusion Data Form:

Question 157: Report “yes” to indicate a new clinical diagnosis of acute GVHD.
Question 158: Report the initial date of diagnosis (2/1/2015).
Question 159: Leave blank. This question will be skipped whenever a diagnosis date has been entered in question 158.
Questions 160-175: Answer these questions based on the assessments performed at the time of diagnosis (2/1/2015).
Questions 176-233: Answer these questions based on any symptoms and treatment documented from the onset of acute GVHD (2/1/2015) up to the diagnosis of chronic GVHD (3/1/2015). This instruction is provided in the note box above question 157.

Six Month Post-Infusion Data Form:

Question 157: Report “no” to indicate acute GVHD did not develop during the reporting period.
Question 158: Leave blank. This question will be skipped whenever question 157 is answered “no.”
Question 159: Report “no” to indicate acute GVHD did not persist from a previous report.

If chronic GVHD has been diagnosed in a prior reporting period, report “no” for questions 157 and 159. Any new or persistent acute GVHD symptoms occurring after the onset of chronic GVHD must be reported in the chronic 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. This instruction has been provided in the note above question 157.

Question 158: 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 (example: 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 date of onset of the first episode of acute GVHD.

If the date of diagnosis is unknown, leave question 158 blank and override the validation error using the code “Unknown.” However, question 158 may not be left blank if treatment for acute GVHD (question 185) is reported “Yes.” If the exact clinical diagnosis date is unknown, but the treatment start date is known, report the date treatment started as the date of acute GVHD diagnosis.

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

Question 159: Did acute GVHD persist since the date of the last report?

Question 159 will only be enabled in FormsNet3SM if the center has reported “no” for question 157 and, therefore, has not reported a date of diagnosis in question 158. If prompted to answer question 159, report “yes” if acute GVHD was diagnosed in a prior reporting period and any of the following conditions are met:

  • The recipient’s acute GVHD symptoms have been active since diagnosis and continue to be active during the current reporting period (i.e., no period of resolution or quiescence since diagnosis).
  • The recipient’s acute GVHD symptoms had resolved before the first day of the current reporting period, but a flare occurred within 30 days of symptom resolution / quiescence.
  • The recipient was not diagnosed with chronic GVHD on or before the date of the flare (see note above question 157).

Report “no” for questions 157 and 159 if the recipient had no active acute GVHD symptoms during the reporting period OR all acute GVHD signs / symptoms during the reporting period occurred after a diagnosis of chronic GVHD (see note above question 157).

Indicate “unknown” if there is no information about the recipient’s GVHD status for the reporting period. This option should be used sparingly and only when no judgment can be made about the presence or absence of GVHD in the reporting period.

Question 160: Was acute GVHD evaluated by biopsy (histology)? (at diagnosis)

Histological tests may be performed to confirm the clinical diagnosis of GVHD; however, the staging and grading of GVHD should be based on clinical evidence, not histological results.

Indicate whether a biopsy was used to diagnose acute GVHD. If “yes,” specify the site(s) / result(s) in questions 161-168. If “no,” continue with question 169.

Questions 161-168: Specify result(s)

For each organ listed, indicate the test result documented on the pathology report as either “positive,” “suggestive,” “negative,” or “inconclusive / equivocal.” “Suggestive” or “inconclusive / equivocal” should be reported if in the final diagnosis or comments section of the pathology report those words are used. If a biopsy was not completed for a specific organ, select “not done” and continue with the next organ. If “other site” is selected, specify the site biopsied in question 167.

Indicate whether documentation was submitted to the CIBMTR (e.g., pathology report) in question 168. For further instructions on how to attach documents in FormsNet3, refer to the training guide.

Question 169: Overall grade of acute GVHD at diagnosis:

Indicate the overall grade of acute GVHD at the time of 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 histologic 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, see the GVHD Grading and Staging table below.

If acute GVHD was present, but the grade at diagnosis was not documented and it cannot be determined from the grading and staging table, report “not applicable.” Examples may include:

  • Only elevated liver function tests without increased bilirubin
  • Any other organ involvement without skin, liver, or gut symptoms attributable to GVHD
  • Lower intestinal tract involvement where the stage cannot be determined in select scenarios lower intestinal tract involvement description below

GVHD Grading and Staging

Extent of Organ Involvement
Stage Skin Liver Gut
1 Rash on <25% of skin1 Bilirubin 2-3 mg/dl2 Diarrhea > 500 ml/day3 or persistent nausea4
Pediatric: 280-555 ml/m2/day or 10-19.9 mL/kg/day
2 Rash on 25-50% of skin Bilirubin 3-6 mg/dl Diarrhea >1000 ml/day
Pediatric: 556-833 ml/m2/day or 20-30 mL/kg/day
3 Rash on >50% of skin Bilirubin 6-15 mg/dl Diarrhea >1500 ml/day
Pediatric: >833 ml/m2/day or > 30 mL/kg/day
4 Generalized erythroderma with bullous formation Bilirubin >15 mg/dl Severe abdominal pain, with or without ileus, and / or grossly blood stool
Grade5
I Stage 1-2 None None
II Stage 3 Stage 1 Stage 1
III Stage 2-3 Stages 2-4
IV6 Stage 4 Stage 4

1 Use “Rule of Nines” (see Percent Body Surfaces table below) or burn chart to determine extent of rash.

2 Range given as total bilirubin. Downgrade one stage if an additional cause of elevated bilirubin has been documented.

3 Volume of diarrhea applies to adults. For pediatric patients, the volume of diarrhea should be based on body surface area. Downgrade one stage if an additional cause of diarrhea has been documented.

4 Persistent nausea with or without histologic evidence of GVHD in the stomach or duodenum.

5 Criteria for grading given as minimum degree of organ involvement required to confer that grade.

6 Grade IV may also include lesser organ involvement with an extreme decrease in performance status

Question 170-175: Indicate the stage for each organ involvement at time of diagnosis of acute GVHD

Report the stage of each organ at 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).

Skin: Select the stage that reflects the body surface area involved with a maculopapular rash attributed to acute GVHD at the time of acute GVHD diagnosis or flare in the reporting period. See Table 5 below to determine the percent of body surface area involved with a rash. Do not report ongoing rash not attributed to acute GVHD at the time of acute GVHD diagnosis or flare.

Percent Body Surfaces

Body Area Percent Total Percentage
Each Arm 9% 18%
Each Leg 18% 36%
Chest & Abdomen 18% 18%
Back 18% 18%
Head 9% 9%
Pubis 1% 1%

Lower intestinal tract (use mL/day for adult recipients and mL/m2/day for pediatric recipients): Select the stage that reflects the volume of diarrhea attributed to acute GVHD at the time of acute GVHD diagnosis or flare in the reporting period. Use mL/day for adult recipients and mL/m2/day for pediatric recipients. Input and output records may be useful in determining the volume of diarrhea. Do not report diarrhea ongoing but not attributed to acute GVHD at the time of acute GVHD diagnosis or flare.

If diarrhea is attributed to acute GVHD during the reporting period, but the volume of stool output is not documented, report “stage 0” for lower intestinal tract involvement. In this case, report “Not Applicable” for the overall grade unless stage 4 acute skin GVHD, stage 4 acute liver GVHD, or an extreme decrease in performance status was also documented at the time point being reported (at diagnosis or maximum grade during the reporting period). Report an overall grade of IV if stage 4 acute skin GVHD, stage 4 acute liver GVHD, or an extreme decrease in performance status is documented at the time point being reported (see GVHD Staging and Grading Table). Report overall grade III if stage 2-3 liver involvement is documented at the time point being reported and there is no evidence of grade IV GVHD.

Upper intestinal tract: Select the stage that reflects the presence of persistent nausea or vomiting attributed to acute GVHD at the time of acute GVHD diagnosis or flare in the reporting period. Do not report nausea or vomiting ongoing but not attributed to acute GVHD at the time of acute GVHD diagnosis or flare.

Liver: Select the stage that reflects the bilirubin level attributed to acute GVHD at the time of acute GVHD diagnosis or flare in the reporting period. Do not report hyperbilirubinemia ongoing but not attributed to acute GVHD at the time of acute GVHD diagnosis or flare.

For recipients who have a normal bilirubin level with elevated transaminase levels attributed to acute GVHD, report this in “Other clinical organ involvement.”

Other site(s) involved with acute GVHD: Indicate whether acute GVHD affected an organ other than skin, upper GI, lower GI, or liver manifesting with hyperbilirubinemia. This includes transaminitis attributed to acute GVHD. Report only other organ involvement at the time of acute GVHD diagnosis or flare in the reporting period. Do not report symptoms ongoing but not attributed to acute GVHD at the time of acute GVHD diagnosis or flare. Specify the other organ system involvement in question 175. If reporting transaminitis under “other site,” write in “transaminitis” rather than “liver” when specifying the site. This will prevent queries regarding incorrectly reporting liver GVHD (with bilirubin elevation) under “other site.”

Question 176: Maximum overall grade of acute GVHD

Indicate the overall maximum grade of acute GVHD since the date of the last report. Grading 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 histologic 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, see the GVHD Grading and Staging table above.

If chronic GVHD was diagnosed during the reporting period, report the maximum severity of acute GVHD prior to the onset of chronic GVHD. See question 157 for further instructions. Acute GVHD grading scenario D below has been provided for further clarification.

Report the recipient’s maximum acute GVHD grade in the reporting period; this may differ from the grade at diagnosis or may be the same. If acute GVHD was present, but the maximum grade was not documented and it cannot be determined from the grading and staging table, report “not applicable.” Examples may include:

  • Only elevated liver function tests without increased bilirubin
  • Any other organ involvement without skin, liver, or gut symptoms attributable to GVHD
  • Lower intestinal tract involvement where the stage cannot be determined in select scenarios lower intestinal tract involvement description above

Acute GVHD Grading Scenarios:

A. A recipient developed stage 2 skin involvement and elevated liver function tests (LFTs) attributed to acute GVHD; however, there was no total bilirubin manifestation. In this case, overall maximum grade I acute GVHD should be reported since the staging / grading can be determined based on the skin involvement alone.

B. A recipient developed acute liver GVHD with elevated LFTs (i.e., transaminases) with no total bilirubin manifestation. The progress notes indicate stage 1 (grade II overall) acute GVHD of the liver. In this case, the clinical manifestations do not fit the criteria used in the GVHD Grading and Staging Table; “not applicable” would be the best option to report.

C. A recipient developed stage 2 skin involvement, which showed improvement in response to topical steroids. However, the recipient then developed hyperbilirubinemia attributed to stage 1 liver involvement; the skin involvement at that time was stage 1. In this case, grade II would be reported (assuming this was the extent of the recipient’s acute GVHD in the reporting period).

D. A recipient developed stage 2 skin involvement which resolved in response to topical steroids. Later in the reporting period, the recipient was diagnosed with mild chronic eye GVHD. Shortly thereafter, they were diagnosed with a stage 3 flare of acute skin GVHD. In this case, grade I would be reported. Do not consider any new or persistent acute GVHD symptoms occurring after the onset of chronic GVHD when completing the acute GVHD section of the form.

Question 177: Date maximum overall grade of acute GVHD

Report the date of maximum acute GVHD involvement, based on clinical grade. If the recipient had multiple instances in which their GVHD reached the same maximum grade, report the earliest date. However, if the same maximum overall grade was achieved, but the specific organ staging varied, report the date of the maximum organ staging consistent with the overall grade reported in question 176.If “not applicable” was reported for question 176, question 177 must be left blank.

Question 178-183: Specify organ involvement at time of maximum grade

Report the stage of involvement for each organ on the date reported in question 177. Refer to the GVHD Grading and Staging Table above for staging guidelines. Also, see additional information included for each organ in the instructions for questions 170-175 above.

Question 184: Were corticosteroids (topical GI) used to treat acute GVHD?

Report “yes” if topical corticosteroids were used to treat GI GVHD. Do not report topical therapies used for skin or lung GVHD in this question. Also, do not report systemic corticosteroids such as prednisone or dexamethasone. Systemic therapies are captured in questions 185-233.

Question 185-233: Was specific therapy given for acute GVHD?

Indicate whether systemic therapy was used to treat acute GVHD during the reporting period. If “yes,” continue with question 186. Report any prophylactic drugs as therapy for acute GVHD if they were continued after the date of diagnosis. If no therapy was given, indicate “no” and continue with question 233. If systemic therapy was given to treat acute GVHD during the reporting period, specify the drugs given in questions 186-233.

When reporting the total dose, report the total delivered dose of each drug during the reporting period. Do not report the prescribed doses or daily doses. For example, if 50 mg/kg of ATGAM was given for 5 days, the center should report a total dose of 250 mg/kg. Drug doses must be reported in whole numbers. If the total dose includes a decimal, round to the nearest whole number.

When reporting the date started, report the first day the drug as given on or after the GVHD diagnosis date (reported in question 158). For prophylaxis medications continued after the date of diagnosis of acute GVHD, report the date of diagnosis as the date started. If an acute GVHD treatment has continued from a previous reporting period, report the original start date and override the error in FormsNet3SM using the code “verified correct.”

Section Updates:

Question Number Date of Change Add/Remove/Modify Description Reasoning (If applicable)
. . . . .
Last modified: Dec 22, 2020

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