Protocol - Graft versus Host Disease

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

Availability

Available

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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

Personnel and Training Required

Personnel who are trained in performing medical record review

Equipment Needs

None

Requirements

Requirement Category	Required
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

Standard	Name	ID	Source

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 ID	Variable Description	dbGaP Mapping
PX850801_Graft_Versus_Host_Disease_Acute_GVHD_Persist_Last_Report
	PX850801030000	Did acute GVHD persist since the date of more last report? show less	N/A
PX850801_Graft_Versus_Host_Disease_Acute_GVHD_Since_Last_Report
	PX850801010000	Did acute GVHD develop since the date of more last report? show less	N/A
PX850801_Graft_Versus_Host_Disease_Chronic_GVHD_Limited_Extensive
	PX850801160000	Specify if chronic GVHD was limited or extensive	N/A
PX850801_Graft_Versus_Host_Disease_Chronic_GVHD_Persist_Since_Last_Report
	PX850801140000	Did chronic GVHD persist since the date of more last report? show less	N/A
PX850801_Graft_Versus_Host_Disease_Chronic_GVHD_Since_Last_Report
	PX850801120000	Did chronic GVHD develop since the date of more last report? show less	N/A
PX850801_Graft_Versus_Host_Disease_Date_Acute_GVHD_Diagnosis
	PX850801020000	Date of acute GVHD diagnosis	N/A
PX850801_Graft_Versus_Host_Disease_Date_Chronic_GVHD_Diagnosis
	PX850801130000	Date of chronic GVHD diagnosis - date estimated	N/A
PX850801_Graft_Versus_Host_Disease_Date_Maximum_Grade_Chronic_GVHD
	PX850801170000	Date of maximum grade of chronic GVHD	N/A
PX850801_Graft_Versus_Host_Disease_Date_Maximum_Overall_Grade_Acute_GVHD
	PX850801050000	Date maximum overall grade of acute GVHD	N/A
PX850801_Graft_Versus_Host_Disease_Liver
	PX850801090000	Specify the maximum overall grade and organ more staging of acute GVHD since the date of last report: Liver show less	N/A
PX850801_Graft_Versus_Host_Disease_Lower_Intestinal_Tract
	PX850801070000	Specify the maximum overall grade and organ more staging of acute GVHD since the date of last report: Lower intestinal tract (use mL/day for adult recipients and mL/kg/day for pediatric recipients) show less	N/A
PX850801_Graft_Versus_Host_Disease_Maximum_Grade_Chronic_GVHD
	PX850801150000	Maximum grade of chronic GVHD {according to more best clinical judgment) show less	N/A
PX850801_Graft_Versus_Host_Disease_Maximum_Overall_Grade_Acude_GVHD
	PX850801040000	Maximum overall grade of acute GVHD	N/A
PX850801_Graft_Versus_Host_Disease_Other_Sites_Involved_Acute_GVHD
	PX850801100000	Specify the maximum overall grade and organ more staging of acute GVHD since the date of last report: Other site(s) involved with acute GVHD show less	N/A
PX850801_Graft_Versus_Host_Disease_Skin
	PX850801060000	Specify the maximum overall grade and organ more staging of acute GVHD since the date of last report: Skin show less	N/A
PX850801_Graft_Versus_Host_Disease_Specify_Other_Sites
	PX850801110000	Specify the maximum overall grade and organ more staging of acute GVHD since the date of last report: Other site(s) involved with acute GVHD. Specify: show less	N/A
PX850801_Graft_Versus_Host_Disease_Upper_Intestinal_Tract
	PX850801080000	Specify the maximum overall grade and organ more staging of acute GVHD since the date of last report: Upper instestinal tract show less	N/A

SCD Curative Therapies

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.

Protocol - Graft versus Host Disease

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Description

Specific Instructions

Availability

Protocol

Personnel and Training Required

Equipment Needs

Requirements

Mode of Administration

Lifestage

Participants

Selection Rationale

Language

Standards

Derived Variables

Process and Review

Protocol Name from Source

Source

General References

Protocol ID

Variables

Measure Name

Release Date

Definition

Purpose

Keywords

Measure Protocols

Publications