← Back to Search

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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 30 and day 100

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2140