Protocol - White Cell Chimerism and Graft Failure

Description

This protocol uses existing medical records to record whether graft failure occurred and information about the cells tested. This protocol contains six of the 122 items from Center for International Blood and Marrow Transplant Research (CIBMTR) Form 2450, which consists of Yes/No and cell information choice responses and a single sample date collection response. Each question includes instructions from the CIBMTR Form 2450 Instruction Manual.

Specific Instructions

This protocol should be used at a series of time points after bone marrow or stem cell transplant, including 100 days, 6 months, 12 months, and then yearly. Also, as a preliminary question, it should be determined if chimerism studies were performed.

Availability

Available

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Protocol

White Cell Chimerism and Graft Failure

1. Did late graft failure occur?

Late (or secondary) graft failure is defined when the recipient meets criteria for initial engraftment but subsequently develops loss of a previously functioning graft by development of at least two lines of cytopenia. Late graft failure is more often associated with allogeneic HCT than with autologous HCT. Some possible causes for late graft failure include graft rejection related to residual host immunity, persistent or progressive disease, low donor cell yield, medication side-effect, infection or GvHD. (Applebaum et al., 2009)

If the recipient meets the criteria of graft failure, check “yes.”

[ ] Yes

[ ] No

2. Date Sample Collected.

Enter the date the sample was collected for the chimerism test.

_ _ _ _ - _ _ - _ _

3. Cell Source.

Report whether the specimen taken for chimerism testing was from a marrow or peripheral blood source.

[ ] Bone marrow

[ ] Peripheral blood

4. Cell type.

Indicate the cell type tested. If the specimen was not sorted for a specific cell line, indicate “unsorted / whole.” See the Chimerism Cell Types table for additional details on cell markers unique to certain cell lines.

[ ] Unsorted / whole

[ ] Red blood cells

[ ] Hematopoietic progenitor cells (CD34+ cells)

[ ] Total mononuclear cells (lymphs & monos)

[ ] T-cells (includes CD3+, CD4+, and/or CD8+)

[ ] B-cells (includes CD19+ or CD20+)

[ ] Granulocytes (includes CD33+ myeloid cells)

[ ] NK cells (CD56+)

[ ] Other

If other, specify: ___________________________

5. Were donor cells detected?

Molecular testing methods include RFLP and VNTR / STR. If a molecular method was used, indicate whether donor cells were detected. Report “yes,” if the testing identified any percentage of cells as being of donor origin.

[ ] Yes

[ ] No

6. Percent donor cells

Molecular testing methods include VNTR / STR, RFLP, and AFLP. Report the percentage of donor cells identified by molecular testing. If the test result did not detect any recipient cell population within the sensitivity of the assay, report 100% donor cells. If the test detected recipient cells, but indicated donor cells “> n%,” report “n + 1” percent donor cells. If the test detected donor cells but indicated donor cells “< n%,” report “n – 1” percent donor cells.

________%

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

Infant, Toddler, Child, Adolescent, Adult, Senior, Pregnancy

Participants

Any age

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 white cell chimerism. 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 investigators 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, 2020

Source

Center for International Blood and Marrow Transplant Research. (2020, January). Post-Transplant Essential Data (Post-TED) Form (CIBMTR Form 2450; Revision 5.0), Questions 16, 70, 73, 74, 78, 79. National Heart, Lung, and Blood Institute.

General References

Appelbaum, F. R., Forman, S. J., Negrin, R. S., & Blume, K. G. (2009). Thomas' hematopoietic cell transplantation: stem cell transplantation (4th ed.). Wiley-Blackwell.

Eapen, M., Brazauskas, R., Walters, M. C., Bernaudin, F., Bo-Subait, K., Fitzhugh, C. D., Hankins, J. S., Kanter, J., Meerpohl, J. J., Bolaños-Meade, J., Panepinto, J. A., Rondelli, D., Shenoy, S., Williamson, J., Woolford, T. L., Gluckman, E., Wagner, J. E., & Tisdale, J. F. (2019). Effect of donor type and conditioning regimen intensity on allogeneic transplantation outcomes in patients with sickle cell disease: A retrospective multicentre, cohort study. Lancet Haematology, 6(11), e585–e596.

Gluckman, E., Cappelli, B., Bernaudin, F., Labopin, M., Volt, F., Carreras, J., Pinto Simões, B., Ferster, A., Dupont, S., de la Fuente, J., Dalle, J. H., Zecca, M., Walters, M. C., Krishnamurti, L., Bhatia, M., Leung, K., Yanik, G., Kurtzberg, J., Dhedin, N., … Eurocord, the Pediatric Working Party of the European Society for Blood and Marrow Transplantation, and the Center for International Blood and Marrow Transplant Research. (2017). Sickle cell disease: An international survey of results of HLA-identical sibling hematopoietic stem cell transplantation. Blood, 129(11), 1548–1556.

Protocol ID

850701

Variables

Export Variables

Variable Name	Variable ID	Variable Description	dbGaP Mapping
PX850701_White_Cell_Chimerism_Graft_Failure_Chimerism_Test_Sample_Date
	PX850701020000	Enter the date the sample was collected for more the chimerism test show less	N/A
PX850701_White_Cell_Chimerism_Graft_Failure_Chimerism_Test_Specimen_Source
	PX850701030000	Report whether the specimen taken for more chimerism test was from a marrow or peripheral blood source show less	N/A
PX850701_White_Cell_Chimerism_Graft_Failure_Donor_Cells_Collected
	PX850701050000	Were donor cells collected?	N/A
PX850701_White_Cell_Chimerism_Graft_Failure_Late_Graft_Failure
	PX850701010000	Did late graft failure occur?	N/A
PX850701_White_Cell_Chimerism_Graft_Failure_Percent_Donor_Cells
	PX850701060000	Percent donor cells	N/A
PX850701_White_Cell_Chimerism_Graft_Failure_Specimen_Cell_Type
	PX850701040100	Indicate the cell type tested	N/A
PX850701_White_Cell_Chimerism_Graft_Failure_Specimen_Cell_Type_Other
	PX850701040200	Indicate the cell type tested: Other - If more other, specify show less	N/A

Curative Therapies

Measure Name

White Cell Chimerism

Release Date

August 16, 2021

Definition

White cell chimerism (or donor leukocyte chimerism) is defined as the percentage of donor cells (0%-100%), usually by T cell (CD3) and myeloid (CD14/15 or CD33), after marrow or hematopoietic cell transplantation. Full donor chimerism is when 100% of marrow and peripheral blood cells are from the donor; anything less than 100% indicates a mixture of donor and recipient cells.

Purpose

This measure is used to determine the outcome of grafting and hematopoietic stem cell transplantation. Donor leukocyte chimerism may decrease before complete graft failure or rejection, in which case sickle symptoms return and sickle treatment must be initiated.

Keywords

white cell chimerism, Center for International Blood and Marrow Transplant Research, CIBMTR, post-transplant, late graft failure, cell source, cell type, donor cells

Measure Protocols

Protocol ID	Protocol Name
850701	White Cell Chimerism and Graft Failure

Publications

There are no publications listed for this protocol.