TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis

Launched by CITY OF HOPE MEDICAL CENTER · May 7, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for severe systemic sclerosis, a serious autoimmune disease that affects the skin and internal organs. The researchers want to see if a combination of a special type of radiation therapy called intensity-modulated radiation therapy (IMRT) and a chemotherapy drug called cyclophosphamide can be safely given before a stem cell transplant. This treatment aims to improve outcomes by targeting the disease more effectively while also protecting sensitive organs like the lungs and kidneys from radiation damage.

To be eligible for this trial, participants should be adults aged 18 to 74 with a specific level of health (Karnofsky performance status of 70 or higher) and must be suitable candidates for the treatment as determined by their doctor. Participants can expect to undergo IMRT and receive cyclophosphamide before the transplant, and they will be monitored closely for any side effects. It's important for potential participants to understand the treatment and sign a consent form, and those who are pregnant or have uncontrolled illnesses will not be able to join. If you're considering this trial, it's a chance to be part of a study that could help improve treatment options for severe systemic sclerosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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