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Protocol - Sickle Cell Disease Transplant Conditioning Regimen

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Description

This protocol uses existing medical records to document the types of conditioning agents, duration of exposure to conditioning agents, and timing of exposure to conditioning agents administered to a patient prior to stem cell transplantation for sickle cell disease.

Specific Instructions

The Sickle Cell Disease Curative Therapy Working Group notes that investigators may need to add more lines to the protocol to capture all agents used. Additionally, area under the curve (AUC) will be applicable only for certain chemotherapy agents.

Protocol

Conditioning Regimen Used

[ ] Chemotherapy Agent

        Specify agent/s used: _____________ Total Dose_________ on Day-__

                                           _____________ Total Dose_________ on Day-__

                                           _____________ Total Dose_________ on Day-__

         Average AUC: Agent ______________ AUC___________

                                 Agent ______________ AUC___________

                              

[ ] Radiation:

           Source/Type________________         Days of Radiation:___________

            Total Dose _________________

[ ] Non-chemotherapy conditioning: Agent ___________  Dose____________

             Frequency________________ Total Dose___________ Day______

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

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

Participants

All ages

Selection Rationale

The Cure Sickle Cell Initiative (CureSCi) Transplant Conditioning Regimen Case Report Form was designed for use in sickle cell disease. It was also chosen because it describes specific conditioning agents, dosages, and timing rather than using general terminology for conditioning regimens, such as “myeloablative” or “non-myeloablative.”

Language

English

Standards
StandardNameIDSource
caDSR Common Data Elements (CDE) Chart Abstraction Hematopoietic Cell Transplantation Conditioning Regimen Assessment Text   7765221 CDE Browser
Derived Variables

None

Process and Review

Not applicable.

Protocol Name from Source

Cure Sickle Cell Initiative (CureSCi) Transplant Conditioning Case Report Form (CRF)

Source

National Heart, Lung, and Blood Institute Cure Sickle Cell Disease Initiative Common Data Element (CDE) Project, Genetics/Assays Working Group. (2020). Transplant Conditioning Regimen Case Report Form.

General References

Gluckman, E., Cappelli, B., Bernaudin, F., Labopin, M., Volt, F., Carreras, J., ... & Eapen, M. (2017). Sickle cell disease: An international survey of results of HLA-identical sibling hematopoietic stem cell transplantation. Blood, 129(11), 1548–1556.

Protocol ID

850401

Variables
Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Average_AUC_1
PX850401050200 Average AUC: AUC N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Average_AUC_2
PX850401060200 Average AUC: AUC N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Average_AUC_Agent_1
PX850401050100 Average AUC: Agent N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Average_AUC_Agent_2
PX850401060100 Average AUC: Agent N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Chemotherapy_Agent_Used_1
PX850401010100 Specify agent/s used N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Chemotherapy_Agent_Used_2
PX850401020100 Specify agent/s used N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Chemotherapy_Agent_Used_3
PX850401030100 Specify agent/s used N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Chemotherapy_Agent_Used_Day_1
PX850401010300 Specify agent/s used: on day N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Chemotherapy_Agent_Used_Day_2
PX850401020300 Specify agent/s used: on day N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Chemotherapy_Agent_Used_Day_3
PX850401030300 Specify agent/s used: on day N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Chemotherapy_Agent_Used_Total_Dose_1
PX850401010200 Specify agent/s used: total dose N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Chemotherapy_Agent_Used_Total_Dose_2
PX850401020200 Specify agent/s used: total dose N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Chemotherapy_Agent_Used_Total_Dose_3
PX850401030200 Specify agent/s used: total dose N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Non_Chemotherapy_Conditioning_Agent
PX850401080100 Non-chemotherapy conditioning: Agent N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Non_Chemotherapy_Conditioning_Day
PX850401080500 Non-chemotherapy conditioning: Day N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Non_Chemotherapy_Conditioning_Dose
PX850401080200 Non-chemotherapy conditioning: Dose N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Non_Chemotherapy_Conditioning_Frequency
PX850401080300 Non-chemotherapy conditioning: Frequency N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Non_Chemotherapy_Conditioning_Total_Dose
PX850401080400 Non-chemotherapy conditioning: Total Dose N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Radiation_Days
PX850401070200 Radiation: Days of Radiation N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Radiation_Source
PX850401070100 Radiation: Source/Type N/A
PX850401_Sickle_Cell_Disease_Transplant_Conditioning_Regimen_Radiation_Total_Dose
PX850401070300 Radiation: Total Dose N/A
Curative Therapies
Measure Name

Sickle Cell Disease Transplant Conditioning Regimen

Release Date

August 16, 2021

Definition

This measure describes the combination of treatments, or conditioning regimen, used to prepare a patient with sickle cell disease for stem cell transplantation, including chemotherapy, monoclonal antibody therapy, other serotherapy, and whole-body radiation therapy.

Purpose

The purpose of a conditioning regimen is to make room in the patient’s bone marrow for new (or donor) blood stem cells to grow, prevent the patient’s body from rejecting the transplanted cells, and increase the chances of a successful transplant. A conditioning regimen used for stem cell transplant plays a significant role in the outcome of the transplant, including potential for success; risk of graft versus host disease; potential for graft failure; and complications including infection, infertility, changes in organ function, and secondary complications such as malignancy.

Keywords

Sickle cell disease, sickle cell disease curative therapies, stem cell transplant, bone marrow transplant, conditioning, radiation, chemotherapy, monoclonal antibody, myeloablative

Measure Protocols
Protocol ID Protocol Name
850401 Sickle Cell Disease Transplant Conditioning Regimen
Publications

There are no publications listed for this protocol.