RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 stem cell transplant to treat severe systemic sclerosis. IMRT delivers total body radiation therapy more precisely and may reduce radiation exposure to sensitive normal organs. Giving chemotherapy, such as cyclophosphamide, and total body irradiation before a donor stem cell transplant helps kill cancer cells in the body and helps make room in the bone marrow for new blood-forming cells (stem cells) to grow. Giving IMRT and cyclophosphamide prior to stem cell transplant may work better in treating severe systemic sclerosis and reduce radiation doses to lung and kidneys compared to cyclophosphamide alone.

Official Title

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

Quick Facts

Study Start:2022-02-24

Study Completion:2024-12-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04380831

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Jeffrey Y Wong

PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center

Duarte, California, 91010

United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

Jeffrey Y Wong, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-24

Study Completion Date2024-12-22

Study Record Updates

Study Start Date2022-02-24

Study Completion Date2024-12-22

Terms related to this study

Additional Relevant MeSH Terms

Systemic Scleroderma