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Alkylating agents

TBI + Cyclophosphamide and Stem Cell Transplant for Scleroderma

Phase < 1
Recruiting
Led By Jeffrey Y Wong
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30 and day 100
Awards & highlights

Summary

This trial is testing the side effects and feasibility of a new way to give total body radiation therapy (IMRT) with the chemotherapy drug cyclophosphamide before stem cell transplant to treat severe systemic sclerosis.

Who is the study for?
This trial is for severe systemic sclerosis patients with good organ function and performance status, who can undergo total body irradiation (TBI) as part of a stem cell transplant. Participants must use birth control and be able to consent. Excluded are those with uncontrolled illnesses, prior radiation therapy without PI approval, or pregnant women due to potential harm.
What is being tested?
The study tests the combination of intensity-modulated radiation therapy (IMRT) and cyclophosphamide before a stem cell transplant in treating severe systemic sclerosis. IMRT aims to precisely target the body while sparing normal organs from excessive radiation exposure.
What are the potential side effects?
Potential side effects include damage to sensitive organs despite precise targeting by IMRT, typical chemotherapy-related issues like nausea, hair loss, fatigue from cyclophosphamide, and complications related to stem cell transplantation such as infection risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30 and day 100
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 and day 100 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean kidney dose
Mean lung dose
Secondary study objectives
Dose homogeneity for lungs, kidneys, and total body
Transplant-related mortality

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (TBI using IMRT, cyclophosphamide, HSCT)Experimental Treatment4 Interventions
Patients undergo TBI using IMRT BID on days -5 and -4 in the absence of disease progression or disease progression. Patients then receive cyclophosphamide on days -3 and -2 and undergo HSCT on day 0 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1240
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Cyclophosphamide
2010
Completed Phase 4
~2320
Total-Body Irradiation
1997
Completed Phase 3
~1180

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,522 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,985 Total Patients Enrolled
Jeffrey Y WongPrincipal InvestigatorCity of Hope Medical Center
8 Previous Clinical Trials
210 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04380831 — Phase < 1
Systemic Scleroderma Research Study Groups: Treatment (TBI using IMRT, cyclophosphamide, HSCT)
Systemic Scleroderma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04380831 — Phase < 1
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04380831 — Phase < 1
~1 spots leftby Dec 2024
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