Using targeted radiation and chemotherapy before stem cell transplant for severe systemic sclerosis
Pilot Study of Total Body Irradiation Using Intensity Modulated Radiation Therapy (IMRT) and Cyclophosphamide Conditioning Regimen Prior to Autologous Hematopoietic Cell Transplantation in Patients With Severe Systemic Sclerosis
EARLY_PHASE1 · City of Hope Medical Center · NCT04380831
This study is testing if a specific type of radiation and chemotherapy before a stem cell transplant can safely help people with severe systemic sclerosis.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | City of Hope Medical Center (other) |
| Drugs / interventions | radiation, cyclophosphamide, chemotherapy |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT04380831 on ClinicalTrials.gov |
What this trial studies
This early phase I trial investigates the feasibility and safety of using intensity-modulated radiation therapy (IMRT) for total body irradiation (TBI) combined with cyclophosphamide prior to stem cell transplantation in patients with severe systemic sclerosis. The study aims to deliver precise radiation doses while minimizing exposure to sensitive organs like the lungs and kidneys. Patients will undergo TBI using IMRT followed by cyclophosphamide treatment before receiving stem cell transplants, with follow-up assessments at 30 and 100 days post-treatment.
Who should consider this trial
Good fit: Ideal candidates include patients with severe systemic sclerosis who have a Karnofsky performance status of 70 or higher and meet specific eligibility criteria for stem cell transplantation.
Not a fit: Patients with uncontrolled illnesses or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with severe systemic sclerosis by reducing side effects and enhancing the effectiveness of stem cell transplantation.
How similar studies have performed: While this approach is innovative, similar studies using targeted radiation and chemotherapy in stem cell transplantation have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (RECRUITING)
Study contacts
- Principal investigator: Jeffrey Y Wong — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Systemic Scleroderma