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Protocol - Graft versus Host Disease

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Description

This protocol uses existing medical records to capture aspects of graft versus host disease resulting from post-transplant complications and additional treatments. The protocol includes three subsections (17 items total) from the Center for International Blood and Marrow Transplant Research (CIBMTR) TED Form 2450 regarding diagnosis and grading of acute and chronic GVHD. Items 1 through 11 (originally numbered 19–21 and 29–36 in the source document) are from the acute section of the form and are not intended for use after a diagnosis of chronic GVHD. Items 12 through 17 (originally numbered 37–42) regard chronic GVHD. Questions regarding treatment of GVHD have been excluded.

Specific Instructions

Suggested follow-up points after stem cell transplant are at 100 days, 6 months, 12 months, and annually thereafter. If an allogeneic donor was used for the recipient's transplant or cellular therapy, report all graft versus host disease occurring in the reporting period.

CIBMTR’s instructions for completing these questions can be found here: https://www.cibmtr.org/manuals/fim/1/en/topic/q15-18-graft-versus-host-disease-allogeneic-only

Protocol

Graft versus Host Disease

1. Did acute GVHD develop since the date of last report?

[ ] Yes

[ ] No

[ ] Unknown

2. Date of acute GVHD diagnosis: _ _ _ _ I _ _ I _ _

                                                YYYY    MM   DD

3. Did acute GVHD persist since the date of last report?

[ ] Yes • Go to question 4

[ ] No • Go to question 12

[ ] Unknown - Go to question 12

Specify the maximum overall grade and organ staging of acute GVHD since the date of last report>:

4. Maximum overall grade of acute GVHD

[ ] I - Rash on < 50% of skin, no liver or gut involvement

[ ] II - Rash on > 50% of skin, bilirubin 2-3 mg/dL, or diarrhea 500-1000 mL/day or persistent nausea or vomiting

 [ ] Ill - Bilirubin 3-15 mg/dL, or gut stage 2-4 diarrhea > 1000 mL/day or severe abdominal pain with or without ileus

[ ] IV - Generalized erythroderma with bullous formation, or bilirubin > 15 mg/dL

[ ] Not applicable (acute GVHD present but cannot be graded)

5. Date maximum overall grade of acute GVHD:

      ______/________/_____

          YYYY        MM            DD

6. Skin

[ ]  Stage 0 - no rash, no rash attributable to acute GVHD

[ ] Stage 1 - maculopapular rash, < 25% of body surface

[ ] Stage 2 - maculopapular rash, 25-50% of body surface

[ ] Stage 3 - generalized erythroderma, > 50% of body surface

[ ] Stage 4 - generalized erythroderma with bullae formation and/or desquamation

7. Lower intestinal tract (use mL/day for adult recipients and mL/kg/day for pediatric recipients)

[ ] Stage 0 - no diarrhea, no diarrhea attributable to acute GVHD /diarrhea< 500 mL/day (adult), or <10 mL/kg/day (pediatric)

[ ] Stage 1 - diarrhea 500 - 1000 mL/day (adult), or 10 - 19.9 mL/kg/day (pediatric)

[ ] Stage 2 - diarrhea 1001 - 1500 mL/day (adult), or 20-30 mL/kg/day             (pediatric)
[ ] Stage 3 - diarrhea > 1500 mL/day (adult), or >30 mL/kg/day (pediatric)

[ ] Stage 4 - severe abdominal pain, with or without ileus, and/or grossly bloody stool

8. Upper intestinal tract

[ ] Stage 0 - no persistent nausea or vomiting

[ ] Stage 1 - persistent nausea or vomiting

9. Liver

[ ] Stage 0 - No liver acute GVHD / bilirubin < 2.0 mg/dL (< 34 µmol/L)

[ ] Stage 1 - bilirubin 2.0- 3.0 mg/dL (34-52 µmol/L)

[ ] Stage 2 - bilirubin 3.1-6.0 mg/dL (53-103 µmol/L)

[ ] Stage 3 - bilirubin 6.1-15.0 mg/dL (104-256 µmol/L)

[ ] Stage 4 - bilirubin > 15.0 mg/dL ( > 256 µmol/L)

10. Other site(s) involved with acute GVHD

[ ]  Yes

[ ] No

11. Specify other site(s): __________________________________

12. Did chronic GVHD develop since the date of last report?

[ ] Yes

[ ] No

[ ] Unknown

13. Date of chronic GVHD diagnosis: _ _ _ _/ _ /_ _ [ ]  Date estimated

                                                               YYYY MM DD

- Go to question 15

14. Did chronic GVHD persist since the date of last report?

[ ] Yes

[ ] No

Specify the maximum grade of chronic GVHD since the date of last report:

15. Maximum grade of chronic GVHD {according to best clinical judgment)

       [ ] Mild   [ ]  Moderate    [ ] Severe   [ ] Unknown

16. Specify if chronic GVHD was limited or extensive

[ ] Limited - localized skin involvement and/or liver dysfunction

[ ] Extensive - one or more of the following:

[ ] generalized skin involvement; or,

[ ] liver histology showing chronic aggressive hepatitis, bridging necrosis or cirrhosis; or,

[ ] involvement of eye: Schirmer's test with < 5 mm wetting; or

[ ] involvement of minor salivary glands or oral mucosa demonstrated on labial biopsy; or

[ ] involvement of any other target organ

17. Date of maximum grade of chronic GVHD:

_ _ _ _ / _ _ / _ _

YYYY   MM  DD

Copyright© 2012 National Marrow Donor Program and the Medical College of Wisconsin, Inc.

Availability

Available

Personnel and Training Required

Personnel who are trained in performing medical record review

Equipment Needs

None

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Medical record abstraction

Lifestage

Child, Adolescent, Adult

Participants

Child, adolescent, and adult patients who have undergone hematopoietic cell transplantation

Selection Rationale

The Sickle Cell Disease Curative Therapies Working Group selected questions from the Center for International Blood and Marrow Transplant Research (CIBMTR) as the best standardized methodology for collecting data on graft versus host disease. CIBMTR forms were developed with the international transplant community to establish a standard set of data elements to be collected for all transplant recipients. Additionally, there are comprehensive Forms Instruction Manuals to help users complete the questions.

Language

English

Standards
StandardNameIDSource
caDSR Common Data Elements (CDE) Acute Graft Versus Host Disease Occurrence Indicator 5106031 CDE Browser
caDSR Common Data Elements (CDE) Diagnosis Present Date 2932795 CDE Browser
caDSR Common Data Elements (CDE) Continue Acute Graft Versus Host Disease Occurrence Indicator 5108286 CDE Browser
caDSR Common Data Elements (CDE) Acute Graft Versus Host Disease Stage Skin Severity Type 5040176 CDE Browser
caDSR Common Data Elements (CDE) Acute Graft Versus Host Disease Stage Lower Gastrointestinal Tract Severity Type 5040178 CDE Browser
caDSR Common Data Elements (CDE) Acute Graft Versus Host Disease Stage Upper Gastrointestinal Tract Severity Type 5040179 CDE Browser
caDSR Common Data Elements (CDE) Acute Graft Versus Host Disease Stage Liver Severity Type 5040180 CDE Browser
caDSR Common Data Elements (CDE) Acute Graft Versus Host Disease Other Anatomic Site Involvement Occurrence Indicator 5040186 CDE Browser
caDSR Common Data Elements (CDE) Acute Graft Versus Host Disease Other Anatomic Site Involvement Occurrence Specify Text 5040187 CDE Browser
caDSR Common Data Elements (CDE) Acute Graft Versus Host Disease Maximum Overall Grade 2603692 CDE Browser
caDSR Common Data Elements (CDE) First Acute Graft Versus Host Disease Maximum Overall Grade Date 7544370 CDE Browser
caDSR Common Data Elements (CDE) Acute Graft Versus Host Disease Other Anatomic Site Involvement Occurrence Specify Text 5040187 CDE Browser
caDSR Common Data Elements (CDE) Chronic Graft Versus Host Disease Occurrence Indicator 5106091 CDE Browser
caDSR Common Data Elements (CDE) Diagnosis Present Date 2932795 CDE Browser
caDSR Common Data Elements (CDE) Continue Acute Graft Versus Host Disease Occurrence Indicator 5108286 CDE Browser
caDSR Common Data Elements (CDE) Acute Graft Versus Host Disease Stage Skin Severity Type 5040176 CDE Browser
caDSR Common Data Elements (CDE) Acute Graft Versus Host Disease Stage Lower Gastrointestinal Tract Severity Type 5040178 CDE Browser
caDSR Common Data Elements (CDE) Acute Graft Versus Host Disease Stage Upper Gastrointestinal Tract Severity Type 5040179 CDE Browser
Derived Variables

None

Process and Review

Not applicable.

Protocol Name from Source

Center for International Blood and Marrow Transplant Research (CIBMTR),Form 2450 (R5.0) Post-Transplant Essential Data, 2021

Source

Center for International Blood and Marrow Transplant Research. (2021, January). Post-Transplant Essential Data (Post-TED) Form (CIBMTR Form 2450; Revision 5.0), Questions 19–21, 29–36, and 37–42. National Heart, Lung, and Blood Institute.

General References

Abraham, J., Janin, A., Gornet, J. M., Peffault de Latour, R., Robin, M., Xhaard, A., de Fontebrune, F. S., Mary, J. Y., Allez, M., Porcher, R., & Socié, G. (2014). Clinical severity scores in gastrointestinal graft-versus-host disease. Transplantation, 97(9), 965–971.

Jagasia, M. H., Greinix, H. T., Arora, M., Williams, K. M., Wolff, D., Cowen, E. W., Palmer, J., Weisdorf, D., Treister, N. S., Cheng, G. S., Kerr, H., Stratton, P., Duarte, R. F., McDonald, G. B., Inamoto, Y., Vigorito, A., Arai, S., Datiles, M. B., Jacobsohn, D., Heller, T., … Flowers, M. E. (2015). National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. Diagnosis and Staging Working Group report. Biology of Blood and Marrow Transplantation, 21(3), 389–401.

Lerner, K. G., Kao, G. F., Storb, R., Buckner, C. D., Clift, R. A., & Thomas, E. D. (1974). Histopathology of graft-vs.-host reaction (GvHR) in human recipients of marrow from HL-A-matched sibling donors. Transplantation Proceedings, 6(4), 367–371.

Mourad, N., Michel, R. P., & Marcus, V. A. (2019). Pathology of gastrointestinal and liver complications of hematopoietic stem cell transplantation. Archives of Pathology & Laboratory Medicine, 143(9), 1131–1143.

Przepiorka, D., Weisdorf, D., Martin, P., Klingemann, H. G., Beatty, P., Hows, J., & Thomas, E. D. (1995). 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplantation, 15(6), 825–828.

Protocol ID

850801

Variables
Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
Blood Sciences Research
Measure Name

Graft versus Host Disease

Release Date

August 16, 2021

Definition

Graft versus host disease (GVHD) is an immunological condition resulting from the reaction of donor immune cells against major or minor histocompatibility antigens of the recipient. Following transplant, donor bone marrow cells initiate an immune response and subsequent injury to recipient cells, tissues, or organs. GVHD may be acute or chronic.

Purpose

Graft versus host disease (GVHD) is a potentially serious complication of bone marrow and stem cell transplants. Acute GVHD is a risk factor for chronic injury to the transplant recipient’s cells, tissues, or organs (most commonly the skin, gut, and liver). GVHD may have a significant impact on quality of life after curative therapy. 

Keywords

Sickle cell disease, SCD, graft versus host disease, GVHD, hematopoietic cell transplantation, AlloHCT, transplant complications, Center for International Blood and Marrow Transplant Research, CIBMTR

Measure Protocols
Protocol ID Protocol Name
850801 Graft versus Host Disease
Publications

There are no publications listed for this protocol.