← Back to Search

Alkylating agents

TBI + Cyclophosphamide and Stem Cell Transplant for Scleroderma

Q: What is the current enrollment size of this clinical trial?

<p>Affirmative. The details accessible on clinicaltrials.gov reveal that this medical investigation, first posted in February 24th 2022, is actively looking for participants. Approximatively 15 study subjects need to be recruited from one centre.</p>

Q: Am I eligible to contribute to this research endeavor?

<p>This trial is searching for 15 adult volunteers with <a href="https://www.withpower.com/clinical-trials/scleroderma">scleroderma</a>, systemic. To be eligible, the following requirements must be met: women of child-bearing potential and men are obligated to utilise satisfactory contraceptive measures (hormonal or barrier <a href="https://www.withpower.com/clinical-trials/birth-control">birth control</a> methods or abstinence) prior to enrolment in the study and for a period of six months post completion; Karnofsky performance score (KPS) >= 70; Systemic sclerosis patients who would qualify as candidates for <a href="https://www.withpower.com/clinical-trials/tbi">TBI</a>-cyclophosphamide (Cy) therapy according to City of Hope's directives and standard operating protocols regarding autologous hematopoietic cell <a href="https://www.withpower.com/clinical-trials/transplant">transplant</a>;</p>

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean kidney dose

Mean lung dose

Secondary outcome measures

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

~1200

Total-Body Irradiation

1997

Completed Phase 3

~1180

Cyclophosphamide

1995

Completed Phase 3

~3770

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

567 Previous Clinical Trials

1,922,645 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,667 Previous Clinical Trials

40,926,117 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment size of this clinical trial?

"Affirmative. The details accessible on clinicaltrials.gov reveal that this medical investigation, first posted in February 24th 2022, is actively looking for participants. Approximatively 15 study subjects need to be recruited from one centre."

Answered by AI

Am I eligible to contribute to this research endeavor?

"This trial is searching for 15 adult volunteers with scleroderma, systemic. To be eligible, the following requirements must be met: women of child-bearing potential and men are obligated to utilise satisfactory contraceptive measures (hormonal or barrier birth control methods or abstinence) prior to enrolment in the study and for a period of six months post completion; Karnofsky performance score (KPS) >= 70; Systemic sclerosis patients who would qualify as candidates for TBI-cyclophosphamide (Cy) therapy according to City of Hope's directives and standard operating protocols regarding autologous hematopoietic cell transplant;"

Answered by AI

Are there any reports of similar results from other Allogeneic Hematopoietic Stem Cell Transplantation experiments?

"Currently, 816 studies exploring Allogeneic Hematopoietic Stem Cell Transplantation are underway. Of those in operation, 154 trials have reached Phase 3 status. Philadelphia is the main hub for this research; however, 2832 other clinical sites throughout the world investigate potential treatments for Allogeneic Hematopoietic Stem Cell Transplantation."

Answered by AI

To what medical conditions may Allogeneic Hematopoietic Stem Cell Transplantation be a viable treatment option?

"Allogeneic Hematopoietic Stem Cell Transplantation is frequently employed in multiple sclerosis treatment and has been seen to be effective with mixed-cell type lymphoma, leukemia, myelocytic acute, and retinoblastoma."

Answered by AI

Are there any available openings for participants in this experiment?

"Confirmed. Clinicaltrials.gov reports that the study, initially posted on February 24th 2022 and most recently updated onMarch 7th of the same year, is currently seeking 15 individuals at a single site."

Answered by AI