TBI Using IMRT (VMAT or Tomotherapy) for the Prevention of Pul Toxicities in Patients Undergoing Donor SCT

NCT04281199 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 19508NCI-2019-08957
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Leukemia; Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

• Completion of all fractions of intensity-modulated radiation therapy (IMRT) total body irradiation (TBI) (volume modulated arc therapy or tomotherapy)

  Will be summarized using percentage and its 95% confidence interval.

  Up to 1 year post transplant

Secondary Outcomes (6)

• Dose homogeneity for all target and non-target structures

  Up to 1 year post transplant

• Rate of adverse events with IMRT TBI

  Up to 1 year post transplant

• Rate of complications with IMRT TBI

  Up to 1 year post transplant

• Non-relapse mortality

  From start of therapy until non-disease related death, or last follow-up, whichever comes first, assessed at 100 days and 1 year

• Extramedullary recurrence

  From start of therapy, assessed at 1 year

Study Arms (1)

Treatment (TBI, IMRT)

EXPERIMENTAL

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

Procedure: Hematopoietic Cell Transplantation; Radiation: Intensity-Modulated Radiation Therapy; Radiation: Tomotherapy; Radiation: Total-Body Irradiation; Radiation: Volume Modulated Arc Therapy

Interventions

Hematopoietic Cell Transplantation PROCEDURE

Undergo HCT

Also known as: HCT, Hematopoietic Stem Cell Transplantation, HSCT, Stem Cell Transplant, stem cell transplantation

Treatment (TBI, IMRT)

Intensity-Modulated Radiation Therapy RADIATION

Undergo IMRT

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

Treatment (TBI, IMRT)

Tomotherapy RADIATION

Undergo IMRT with tomotherapy

Also known as: helical tomotherapy

Treatment (TBI, IMRT)

Total-Body Irradiation RADIATION

Undergo TBI

Also known as: TBI, Total Body Irradiation, Whole Body Irradiation, Whole-Body Irradiation

Treatment (TBI, IMRT)

Volume Modulated Arc Therapy RADIATION

Undergo IMRT with VMAT

Also known as: VMAT

Treatment (TBI, IMRT)

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Karnofsky performance status (KPS) \>= 70
• Acute leukemia or myelodysplastic patients evaluated within 30 days of start of conditioning regimen who would be candidates for TBI-cyclophosphamide (Cy) or TBI-etoposide (VP16) per City of Hope (COH) standard operating procedure (SOP) for allogeneic hematopoietic stem cell transplant
• Patients must be suitable for TBI conditioning regimens as part of transplant per the referring hematologist
• Patients must have adequate organ function for hematopoietic cell transplantation (HCT) as determined by the hematologist
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation
• All subjects must have the ability to understand the treatment and the willingness to sign a written informed consent
• The effects of total body radiation on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
• Although not mandated by the protocol, the results of the imaging scans and labs (complete blood count \[CBC\], comprehensive metabolic panel \[CMP\]) that are performed as part of the standard work up should be available and should have been done within 2 months prior to study entry
• Prior therapy (chemotherapy, immunotherapy, radiotherapy) must be completed at least 2 weeks prior to TBI
• All patients with prior radiotherapy need to be reviewed with the principal investigator (PI) to determine eligibility
• Prior therapy with chemotherapeutic agents is allowed
• DONOR: Donor evaluation and eligibility will be assessed per current COH standard operating procedure

You may not qualify if:

• Patients should not have any uncontrolled illness including ongoing or active infection
• Prior history of radiation therapy must be presented to study PI for eligibility determination
• Pregnant women are excluded from this study because total body irradiation is an agent with the potential for teratogenic or abortifacient effects
• Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Stem Cell Transplantation; Hematopoietic Stem Cell Transplantation; Radiotherapy, Intensity-Modulated; Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Investigative Techniques

Study Officials

• Savita V Dandapani

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Radiation

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 24, 2020
• Study Start: February 28, 2020
• Primary Completion (Estimated): July 14, 2026
• Study Completion (Estimated): July 14, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

US (1)