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

Primary Purpose

Acute Leukemia, Myelodysplastic Syndrome

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hematopoietic Cell Transplantation
Intensity-Modulated Radiation Therapy
Tomotherapy
Total-Body Irradiation
Volume Modulated Arc Therapy
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Leukemia

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (TBI, IMRT)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Dose homogeneity for all target and non-target structures
Will use dose volume histograms.
Rate of adverse events with IMRT TBI
Type, frequency, severity, attribution, time course, duration, and complications will be measured by Bearman and Common Terminology Criteria for Adverse Events version 5.0. Tables will be constructed to summarize the observed incidence, severity, and type of toxicity, including infection.
Rate of complications with IMRT TBI
Will include acute graft versus host disease (aGVHD), infections, delayed neutrophil/platelet engraftment. Cumulative incidence rate will be used for aGVHD, and chronic GVHD.
Non-relapse mortality
Cumulative incidence rate will be used.
Extramedullary recurrence
Relapse free survival
Kaplan-Meier curves will be used.

Full Information

First Posted
February 20, 2020
Last Updated
April 4, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04281199
Brief Title
TBI Using IMRT (VMAT or Tomotherapy) for the Prevention of Pul Toxicities in Patients Undergoing Donor SCT
Official Title
Multi-Institutional Pilot Study of Total Body Irradiation Using Intensity Modulated Radiation Therapy (IMRT) (VMAT or Tomotherapy) for Allogeneic HSCT With New Lung Radiation Dose Guidelines to Prevent Pul Toxicities
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
PRIMARY OBJECTIVES: I. To test whether the investigators can achieve a mean lung dose of < 8 Gy and still treat the total body at a minimum of 85% prescribed dose in patients undergoing allogeneic hematopoietic stem cell transplantation who are eligible for standard total body irradiation (TBI)-based myeloablative regimens. II. To evaluate TBI coverage from tomotherapy and VMAT with new lung sparing guidelines. III. To assess the rate of adverse events with intensity-modulated radiation therapy (IMRT) TBI: type, frequency, severity, attribution, time course, duration, and complications (acute graft versus host disease [GvHD], infections, and delayed neutrophil/platelet engraftment) measured by Bearman and Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. SECONDARY OBJECTIVES: I. To evaluate dose homogeneity for all target and non-target structures using dose volume histograms. II. To evaluate non-relapse mortality at 100 days, and 1 year post IMRT TBI. III. To evaluate relapse-free survival (RFS) at 100 days, and 1 year post IMRT TBI. IV. To evaluate extramedullary recurrence rate at 1 year post IMRT TBI. OUTLINE: Patients undergo TBI using IMRT with VMAT or tomotherapy twice daily (BID) on days -7 to -4 then undergo stem cell transplantation on day 0. After completion of study treatment, patients are followed up at 100 days and 1 year post transplant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia, Myelodysplastic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Radiation
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (TBI, IMRT)
Arm Type
Experimental
Arm Description
Patients undergo TBI using IMRT with VMAT or tomotherapy BID on days -7 to -4 then undergo stem cell transplantation on day 0.
Intervention Type
Procedure
Intervention Name(s)
Hematopoietic Cell Transplantation
Other Intervention Name(s)
HCT, Hematopoietic Stem Cell Transplantation, HSCT, Stem Cell Transplant, stem cell transplantation
Intervention Description
Undergo HCT
Intervention Type
Radiation
Intervention Name(s)
Intensity-Modulated Radiation Therapy
Other Intervention Name(s)
IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy
Intervention Description
Undergo IMRT
Intervention Type
Radiation
Intervention Name(s)
Tomotherapy
Other Intervention Name(s)
helical tomotherapy
Intervention Description
Undergo IMRT with tomotherapy
Intervention Type
Radiation
Intervention Name(s)
Total-Body Irradiation
Other Intervention Name(s)
TBI, Total Body Irradiation, Whole Body Irradiation, Whole-Body Irradiation
Intervention Description
Undergo TBI
Intervention Type
Radiation
Intervention Name(s)
Volume Modulated Arc Therapy
Other Intervention Name(s)
VMAT
Intervention Description
Undergo IMRT with VMAT
Primary Outcome Measure Information:
Title
Completion of all fractions of intensity-modulated radiation therapy (IMRT) total body irradiation (TBI) (volume modulated arc therapy or tomotherapy)
Description
Will be summarized using percentage and its 95% confidence interval.
Time Frame
Up to 1 year post transplant
Secondary Outcome Measure Information:
Title
Dose homogeneity for all target and non-target structures
Description
Will use dose volume histograms.
Time Frame
Up to 1 year post transplant
Title
Rate of adverse events with IMRT TBI
Description
Type, frequency, severity, attribution, time course, duration, and complications will be measured by Bearman and Common Terminology Criteria for Adverse Events version 5.0. Tables will be constructed to summarize the observed incidence, severity, and type of toxicity, including infection.
Time Frame
Up to 1 year post transplant
Title
Rate of complications with IMRT TBI
Description
Will include acute graft versus host disease (aGVHD), infections, delayed neutrophil/platelet engraftment. Cumulative incidence rate will be used for aGVHD, and chronic GVHD.
Time Frame
Up to 1 year post transplant
Title
Non-relapse mortality
Description
Cumulative incidence rate will be used.
Time Frame
From start of therapy until non-disease related death, or last follow-up, whichever comes first, assessed at 100 days and 1 year
Title
Extramedullary recurrence
Time Frame
From start of therapy, assessed at 1 year
Title
Relapse free survival
Description
Kaplan-Meier curves will be used.
Time Frame
From start of therapy, assessed at 100 days and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Savita V Dandapani
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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