Status:
RECRUITING
TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Systemic Scleroderma
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
This early phase I trial studies the side effects and feasibility of total body irradiation using intensity modulation radiation therapy (IMRT) when given in combination with cyclophosphamide prior to...
Detailed Description
PRIMARY OBJECTIVES: I. To assess the feasibility of using IMRT to deliver total body irradiation (TBI) to 800 cGy while keeping mean lung and kidney doses to 200 cGy. II. To assess the safety/feasib...
Eligibility Criteria
Inclusion
- Karnofsky performance status (KPS) \>= 70
- Systemic sclerosis patients evaluated within 30 days of start of conditioning regimen who would be candidates for TBI-cyclophosphamide (Cy) per City of Hope (COH) guidelines and standard operating procedures (SOP) for autologous hematopoietic cell transplant
- Patients must be suitable for TBI conditioning regimens as part of transplant per radiation the referring hematologist
- Patients must have adequate organ function for HCT as determined by the hematologist
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation
- All subjects must have the ability to understand the treatment and the willingness to sign a written informed consent
Exclusion
- Patients should not have any uncontrolled illness including ongoing or active infection
- Prior history of radiation therapy must be presented to study principal investigator (PI) for eligibility determination
- Pregnant women are excluded from this study because total body irradiation is an agent with the potential for teratogenic or abortifacient effects
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Key Trial Info
Start Date :
February 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 22 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04380831
Start Date
February 24 2022
End Date
December 22 2026
Last Update
March 20 2025
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010