Advanced Radiation Techniques for Stem Cell Transplant Recipients

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: City of Hope Medical Center

Disqualifiers: Uncontrolled illness, Active infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 101

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies how well radiation therapy techniques, volumetric modulated arc therapy (VMAT) and tomotherapy, work to reduce doses to the lung compared to standard total body irradiation methods to prevent pulmonary toxicities. Standard total body irradiation is limited in its ability to spare normal organs, with only the lung being partially spared by lung blocks and risks the development of pulmonary toxicities. Reducing the doses to the lung using VMAT or tomotherapy may improve survival and decrease long term lung side effects in patients undergoing stem cell transplant.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, prior therapy like chemotherapy, immunotherapy, or radiotherapy must be completed at least 2 weeks before starting total body irradiation.

Is advanced radiation therapy safe for stem cell transplant patients?

Research shows that advanced radiation techniques like VMAT and TBI are generally safe for stem cell transplant patients, with efforts made to minimize damage to healthy organs. Studies have focused on reducing lung exposure and managing normal organ toxicity, which are key safety concerns. ^{1 2 3 4 5}

How is the treatment VMAT-TBI different from other treatments for stem cell transplant recipients?

VMAT-TBI (Volumetric Modulated Arc Therapy Total Body Irradiation) is unique because it allows for more precise targeting of radiation, reducing exposure to healthy organs compared to conventional total body irradiation. This precision helps minimize side effects and is particularly beneficial for patients undergoing stem cell transplants. ^{2 3 4 5 6}

What data supports the effectiveness of the treatment Tomotherapy, Total-Body Irradiation, Total Body Irradiation, TBI, VMAT, Volumetric Modulated Arc Therapy, VMAT for stem cell transplant recipients?

Research shows that using advanced radiation techniques like VMAT and TomoTherapy for total body irradiation in stem cell transplant patients can improve survival rates and reduce severe side effects compared to traditional methods. These techniques allow for better control of radiation doses, protecting critical organs while effectively targeting cancer cells. ^{4 5 6 7 8}

Who Is on the Research Team?

Savita V Dandapani

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are allowed to have received treatment with chemotherapy drugs in the past.

Karnofsky performance status (KPS) >= 70

Patients must be suitable for TBI conditioning regimens as part of transplant per the referring hematologist

Exclusion Criteria

Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Prior history of radiation therapy must be presented to study PI for eligibility determination

Patients should not have any uncontrolled illness including ongoing or active infection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo total body irradiation using IMRT with VMAT or tomotherapy twice daily on days -7 to -4

4 days

Daily visits for radiation treatment

Stem Cell Transplantation

Participants undergo stem cell transplantation on day 0

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including adverse events and survival rates, at 100 days and 1 year post transplant

1 year

Follow-up visits at 100 days and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Tomotherapy
• Total-Body Irradiation
• VMAT

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (TBI, IMRT) Experimental Treatment 5 Interventions

Patients undergo TBI using IMRT with VMAT or tomotherapy BID on days -7 to -4 then undergo stem cell transplantation on day 0.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

The Stanford Volumetric Modulated Arc Therapy Total Body Irradiation Technique. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Volumetric Modulated Arc Therapy Enabled Total Body Irradiation (VMAT-TBI): Six-year Clinical Experience and Treatment Outcomes. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Optimized Conformal Total Body Irradiation Among Recipients of TCRαβ/CD19-Depleted Grafts in Pediatric Patients With Hematologic Malignancies: Single-Center Experience. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Volumetric modulated arc therapy total body irradiation in pediatric and adolescent/young adult patients undergoing stem cell transplantation: Early outcomes and toxicities. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Image-guided volumetric-modulated arc therapy of total body irradiation: An efficient workflow from simulation to delivery. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Implementing failure mode and effect analysis to improve the safety of volumetric modulated arc therapy for total body irradiation. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Total body irradiation with volumetric modulated arc therapy: Dosimetric data and first clinical experience. [2018]

8. Ireland pubmed.ncbi.nlm.nih.gov

Dosimetric study of volumetric modulated arc therapy fields for total marrow irradiation. [2012]