Acute LeukemiaPhase 1NCT04281199
TBI Using IMRT (VMAT or Tomotherapy) for the Prevention of Pul Toxicities in Patients Undergoing Donor SCT
A Phase 1 study testing Hematopoietic Cell Transplantation, Intensity-Modulated Radiation Therapy and Tomotherapy in people with Acute Leukemia and Myelodysplastic Syndrome, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Acute Leukemia, Myelodysplastic Syndrome
- What is being tested?
- Hematopoietic Cell Transplantation, Intensity-Modulated Radiation Therapy and Tomotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2020to 24 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Acute Leukemia, Myelodysplastic Syndrome
- Being tested
- Hematopoietic Cell Transplantation, Intensity-Modulated Radiation Therapy, Tomotherapy, Total-Body Irradiation, Volume Modulated Arc Therapy
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematopoietic Cell TransplantationProcedure or surgery
Also called HCT, Hematopoietic Stem Cell Transplantation, HSCT, Stem Cell Transplant
Undergo HCT
Intensity-Modulated Radiation TherapyRadiation
Also called IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy
Undergo IMRT
TomotherapyRadiation
Also called helical tomotherapy
Undergo IMRT with tomotherapy
Total-Body IrradiationRadiation
Also called TBI, Total Body Irradiation, Whole Body Irradiation, Whole-Body Irradiation
Undergo TBI
Volume Modulated Arc TherapyRadiation
Also called VMAT
Undergo IMRT with VMAT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Hematopoietic Cell Transplantation; Radiation: Intensity-Modulated Radiation Therapy; Radiation: Tomotherapy; Radiation: Total-Body Irradiation; Radiation: Volume Modulated Arc Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year post transplant
Secondary outcomes (6)
Dose homogeneity for all target and non-target structures
Will use dose volume histograms.
Measured: Up to 1 year post transplant
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.
Measured: Up to 1 year post transplant
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.
Measured: Up to 1 year post transplant
Non-relapse mortality
Cumulative incidence rate will be used.
Measured: 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
Measured: From start of therapy, assessed at 1 year
Relapse free survival
Kaplan-Meier curves will be used.
Measured: From start of therapy, assessed at 100 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start28 Feb 2020
- Primary completion24 Jun 2027 (estimated)
- Study completion24 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Radiation
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Savita V Dandapani, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281199
- Sponsor's protocol ID
- 19508
- Other IDs
- NCI-2019-08957, 19508
- Status last verified
- Aug 2026
- First submitted
- 20 Feb 2020
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04281199
- Acronym / sponsor ID
- 19508
- Conditions
- Acute Leukemia, Myelodysplastic Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 24 Jun 2027 (estimated)
- Study completion
- 24 Jun 2027 (estimated)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Radiation
| Arm | Type | Receives |
|---|---|---|
| Treatment (TBI, IMRT) | Experimental | Procedure: Hematopoietic Cell Transplantation, Radiation: Intensity-Modulated Radiation Therapy, Radiation: Tomotherapy, Radiation: Total-Body Irradiation, Radiation: Volume Modulated Arc TherapyPatients undergo TBI using IMRT with VMAT or tomotherapy BID on days -7 to -4 then undergo stem cell transplantation on day 0. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hematopoietic Cell TransplantationAlso: HCT, Hematopoietic Stem Cell Transplantation, HSCT, Stem Cell TransplantUndergo HCT | Procedure or surgery | Treatment (TBI, IMRT) |
| Intensity-Modulated Radiation TherapyAlso: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated RadiotherapyUndergo IMRT | Radiation | Treatment (TBI, IMRT) |
| TomotherapyAlso: helical tomotherapyUndergo IMRT with tomotherapy | Radiation | Treatment (TBI, IMRT) |
| Total-Body IrradiationAlso: TBI, Total Body Irradiation, Whole Body Irradiation, Whole-Body IrradiationUndergo TBI | Radiation | Treatment (TBI, IMRT) |
| Volume Modulated Arc TherapyAlso: VMATUndergo IMRT with VMAT | Radiation | Treatment (TBI, IMRT) |
Primary outcome
Completion of all fractions of intensity-modulated radiation therapy (IMRT) total body irradiation (TBI) (volume modulated arc therapy or tomotherapy)
Time frame: Up to 1 year post transplant
Will be summarized using percentage and its 95% confidence interval.
6 secondary outcomes
Dose homogeneity for all target and non-target structures
Time frame: Up to 1 year post transplant
Rate of adverse events with IMRT TBI
Time frame: Up to 1 year post transplant
Rate of complications with IMRT TBI
Time frame: Up to 1 year post transplant
Non-relapse mortality
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
Extramedullary recurrence
Time frame: From start of therapy, assessed at 1 year
Relapse free survival
Time frame: From start of therapy, assessed at 100 days and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Savita V Dandapani principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hematopoietic Cell Transplantation, Intensity-Modulated Radiation Therapy and Tomotherapy in people with Acute Leukemia and Myelodysplastic Syndrome, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of all fractions of intensity-modulated radiation therapy (IMRT) total body irradiation (TBI) (volume modulated arc therapy or tomotherapy) (time frame: Up to 1 year post transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.