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Radiation Therapy

Advanced Radiation Techniques for Stem Cell Transplant Recipients

Phase 1
Waitlist Available
Led By Savita V Dandapani
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 younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post transplant
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing how well two different radiation therapy techniques work to reduce doses to the lung compared to the standard method. The hope is that this will improve survival and decrease long term lung side effects in patients undergoing stem cell transplant.

Who is the study for?
This trial is for patients with acute leukemia or myelodysplastic syndrome who are suitable for stem cell transplant and total body irradiation (TBI). They must have a performance status indicating they can care for themselves, agree to use contraception, and not be pregnant. Prior treatments are allowed if completed two weeks before TBI.
What is being tested?
The study tests whether advanced radiation techniques like VMAT or tomotherapy can better protect the lungs from damage during TBI compared to standard methods in patients undergoing donor stem cell transplants. The goal is to improve survival rates and reduce long-term lung complications.
What are the potential side effects?
While specific side effects aren't listed, potential risks include those commonly associated with radiation therapy such as skin irritation, fatigue, nausea, and increased risk of infection due to lowered immune response post-transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Completion of all fractions of intensity-modulated radiation therapy (IMRT) total body irradiation (TBI) (volume modulated arc therapy or tomotherapy)
Secondary study objectives
Dose homogeneity for all target and non-target structures
Non-relapse mortality
Rate of adverse events with IMRT TBI
+2 more

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, IMRT)Experimental Treatment5 Interventions
Patients undergo TBI using IMRT with VMAT or tomotherapy BID on days -7 to -4 then undergo stem cell transplantation on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2140
Tomotherapy
2013
Completed Phase 2
~140
Volume Modulated Arc Therapy
2017
Completed Early Phase 1
~30
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~360
Total-Body Irradiation
1997
Completed Phase 3
~1180

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,112,077 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
605 Previous Clinical Trials
1,923,585 Total Patients Enrolled
Savita V DandapaniPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
23 Total Patients Enrolled

Media Library

Tomotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04281199 — Phase 1
Myelodysplastic Syndrome Research Study Groups: Treatment (TBI, IMRT)
Myelodysplastic Syndrome Clinical Trial 2023: Tomotherapy Highlights & Side Effects. Trial Name: NCT04281199 — Phase 1
Tomotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04281199 — Phase 1
~0 spots leftby Dec 2024
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