Hematologic MalignancyNCT04509765

A Phase II Single-arm Study of Total Body Irradiation With Linac Based VMAT and IGRT

A study testing Linac Based VMAT TBI in people with Hematologic Malignancy, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Single institution study of safety of linac based VMAT TBI for myeloablative treatment in hematologic malignancies. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hematologic Malignancy
What is being tested?: Linac Based VMAT TBI
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: 22 Sep 2020to 11 Feb 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18
Patients undergoing related, unrelated (including cord blood) hematopoietic progenitor cell (HPC) transplant, in which the protocol requires >12 Gray of TBI, as part of the conditioning regimen.
Conditioning regimens outlined per BMT SOP: CLNTX007: Selection of Conditioning Regimens for Blood and Marrow Transplantation - ADULTS.
Referral from the blood and marrow transplant (BMT) program for full-dose TBI, who meet inclusion and exclusion criterial per BMT SOPs.
BMT program will initiate referral, utilizing Form: 170102, Radiation Oncology Consultation.
Patients undergo pre-transplant testing, as defined in BMT SOPs:CLNAL002: Related (MRD, Haplo) Allogeneic Recipient Evaluation and Management or CLNAL011: Unrelated (MUD, MMUD, CBU) Allogeneic Recipient Evaluation and Management, per below.

Show all 18Show fewer

BMT SOP's include baseline pulmonary function tests (PFTs). Patient with decreased FVC, FEV1 and or DLCO (adjusted for hemoglobin) or pulmonary history will have pulmonary consult, at the discretion of the BMT physician prior to undergoing myeloablative radiation.
Medical history and physical by BMT provider.
The following laboratory tests (additional testing may be required for positive results):
ABO group and Rh type
Red Blood Cell Antibody Screen.
HLA typing and confirmatory typing
HLA antibody screen, class I and II, performed within 30 days of transplant.
Complete blood count (CBC) with differential.
Basic metabolic panel, including glucose and to include at a minimum electrolyte evaluation of potassium, calcium, magnesium, and phosphorus.
Blood urea nitrogen (BUN)
Creatinine
Liver Function Tests including: Total bilirubin, Alkaline phosphatase, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Lactate dehydrogenase (LDH), Albumin, Total Protein, Urinalysis

Who cannot join

Patient receiving less than 1200 cGy of TBI
Previous history of thoracic radiation therapy including previous TBI
All premenopausal women will require a urine qualitative pregnancy test to exclude pregnancy. Pregnant women will be excluded from the study.
Prisoners
Patient not meeting transplant criteria per BMT physician.

Trial locations and contacts

1 site in 1 country.

United States1 site

NYU Langone Health
New York, New York, 10016

Other trials in United States

About this study

Official title: A Phase II Single-Arm Study of Total Body Irradiation With Linac Based Volumetric Modulated Arc Therapy (VMAT) and Image Guided Radiation Therapy (IGRT)

Single institution study of safety of linac based VMAT TBI for myeloablative treatment in hematologic malignancies.

Read the detailed description

Total Body Irradiation (TBI) continues to play an important role in myeloablative and non-myeloablative conditioning regimens for Allogeneic Stem Cell Transplant (ASCT). When TBI is used as part of a myeloablative regimen, it is combined with chemotherapy to eradicate malignant cells, as well as to immunosuppress the host to prevent rejection of donor hematopoietic progenitor cells (HPC).

This study is a single-institution study to assess the safety of linac based VMAT TBI for myeablative sreatment in hematologic malignancies.

Conditions: Hematologic Malignancy
Being tested: Linac Based VMAT TBI
Keywords: Myeloablative Treatment, Total Body Irradiation
Medical subject headings: Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Linac Based VMAT TBIRadiation
Use of linac based Volumetric Arc Therapy (VMAT) to deliver Total Body Irradiation (TBI). The study intervention is a VMAT based delivery technique using a 6 MV photon beam from a Varian TrueBeam® (Palo Alto, CA) equipped with a Millennium multi-leaf collimation (MLC) system3. TBI will be delivered using a Varian TrueBeam linear accelerator with photon beam VMAT capability. VMAT is a radiation technique combining dynamic photon fluence modulation using multi-leaf collimation (MLC) with gantry rotation to deliver a highly conformal dose distribution with improved target coverage and sparing of organs at risk (OARs).

Study groups in NCT04509765
Study group	Role	What they receive
Patients with Hematologic Malgnancies	Experimental	Not described Receives: Radiation: Linac Based VMAT TBI

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Patients Who Achieve Excellent Coverage While Sparing the Lung
Excellent coverage while sparing the lung is quantified by meeting the following dosimetric parameters (all parameters must be met):
1. V100%= >90% (90% of PTV volume getting 100% of the dose).
2. D98>85% (98% of the volume getting at least 85% of the dose).
3. Mean Lung dose <900cGy.
Measured: Up to 1 year post-transplant

Secondary outcomes (6)

Event Free Survival (EFS)
Interval from day of transplant to date of first objective disease progression or relapse or death from any cause. Subjects without these failures will be censored at the last date that they were assessed and deemed failure free.
Measured: Up to 1 year post-transplant
Proportion of Patients Who Have Achieved a Maximum Dose to 2cc of the Entire Body (D2cc) < 130% of Rx Dose.
Number of participants with Maximum dose to 2cc of the entire body (D2cc) <130% of Rx dose
Measured: Up to 150 days post-transplant
Cumulative Incidence Rate of Idiopathic Pneumonia Syndrome
Non-infectious pneumonia syndrome is defined by the American Thoracic Society as at least 1 of the following without concurrent infection detected on blood culture, broncoalveolar lavage, lung biopsy or sputum:
There must also be the absence of cardiac dysfunction, acute renal failure, or iatrogenic fluid overload as etiology for pulmonary dysfunctionMultilobar infiltrates on chest radiograph or computed tomography (CT); Symptoms and signs of pneumonia including dyspnea, cough, cyanosis, hypoxia or pyrexia; New or increased restrictive patters on pulmonary function testing or increased alveolar to arterial oxygen difference
Measured: Up to 100 Days Post-Transplant
Proportion of Patients Who Have Achieved a Maximum Dose to 0.03cc of OARs < 120% of Rx Dose.
Number of participants with Maximum dose to 0.03cc of organs at risk <120% of Rx dose
Measured: Up to 150 days post-transplant
Occurrence of Acute GVHD, Transplant Related Mortality, or Mortality in the First 100 Days Following Transplant
Number of participants who experienced acute GVHD or all-cause mortality within 100 days following bone marrow transplant
Measured: 100 days post-transplant
Proportion of Patients Who Achieved a Mean Dose to Each Kidney (Dmean) < 11Gy
Number of participants with mean dose of <11Gy (1100 cGy) to either kidney
Measured: Up to 150 days post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Sep 202011 Feb 2025

First posted12 Aug 2020
Study start22 Sep 2020
Primary completion11 Feb 2025
Study completion11 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04509765
Sponsor's protocol ID: 19-00664
Status last verified: Apr 2026
First submitted: 10 Aug 2020
Last updated: 4 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hematologic Malignancy trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Single-Arm Study of Total Body Irradiation With Linac Based Volumetric Modulated Arc Therapy (VMAT) and Image Guided Radiation Therapy (IGRT)
ClinicalTrials.gov ID: NCT04509765
Acronym / sponsor ID: 19-00664
Conditions: Hematologic Malignancy
Keywords: Myeloablative Treatment, Total Body Irradiation
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Study start: 22 Sep 2020 (actual)
Primary completion: 11 Feb 2025 (actual)
Study completion: 11 Feb 2025 (actual)
First posted: 12 Aug 2020 (actual)
Results: Posted 4 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Single institution study of safety of linac based VMAT TBI for myeloablative treatment in hematologic malignancies.

Detailed description

This study is a single-institution study to assess the safety of linac based VMAT TBI for myeablative sreatment in hematologic malignancies.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients with Hematologic Malgnancies	Experimental	Radiation: Linac Based VMAT TBI

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Age ≥ 18
Patients undergoing related, unrelated (including cord blood) hematopoietic progenitor cell (HPC) transplant, in which the protocol requires >12 Gray of TBI, as part of the conditioning regimen.
Referral from the blood and marrow transplant (BMT) program for full-dose TBI, who meet inclusion and exclusion criterial per BMT SOPs.
Medical history and physical by BMT provider.
The following laboratory tests (additional testing may be required for positive results):

Key exclusion criteria (5 listed)

Patient receiving less than 1200 cGy of TBI
Previous history of thoracic radiation therapy including previous TBI
All premenopausal women will require a urine qualitative pregnancy test to exclude pregnancy. Pregnant women will be excluded from the study.
Prisoners
Patient not meeting transplant criteria per BMT physician.

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
Linac Based VMAT TBIUse of linac based Volumetric Arc Therapy (VMAT) to deliver Total Body Irradiation (TBI). The study intervention is a VMAT based delivery technique using a 6 MV photon beam from a Varian TrueBeam® (Palo Alto, CA) equipped with a Millennium multi-leaf collimation (MLC) system3. TBI will be delivered using a Varian TrueBeam linear accelerator with photon beam VMAT capability. VMAT is a radiation technique combining dynamic photon fluence modulation using multi-leaf collimation (MLC) with gantry rotation to deliver a highly conformal dose distribution with improved target coverage and sparing of organs at risk (OARs).	Radiation	Patients with Hematologic Malgnancies

Primary outcome

Proportion of Patients Who Achieve Excellent Coverage While Sparing the Lung
Time frame: Up to 1 year post-transplant
Excellent coverage while sparing the lung is quantified by meeting the following dosimetric parameters (all parameters must be met): 1. V100%= >90% (90% of PTV volume getting 100% of the dose). 2. D98>85% (98% of the volume getting at least 85% of the dose). 3. Mean Lung dose <900cGy.

6 secondary outcomes

Event Free Survival (EFS)
Time frame: Up to 1 year post-transplant
Proportion of Patients Who Have Achieved a Maximum Dose to 2cc of the Entire Body (D2cc) < 130% of Rx Dose.
Time frame: Up to 150 days post-transplant
Cumulative Incidence Rate of Idiopathic Pneumonia Syndrome
Time frame: Up to 100 Days Post-Transplant
Proportion of Patients Who Have Achieved a Maximum Dose to 0.03cc of OARs < 120% of Rx Dose.
Time frame: Up to 150 days post-transplant
Occurrence of Acute GVHD, Transplant Related Mortality, or Mortality in the First 100 Days Following Transplant
Time frame: 100 days post-transplant
Proportion of Patients Who Achieved a Mean Dose to Each Kidney (Dmean) < 11Gy
Time frame: Up to 150 days post-transplant

Results and safety

Results posted to the registry on 4 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Hematologic Malgnancies	36	33

Primary outcome: Proportion of Patients Who Achieve Excellent Coverage While Sparing the Lung

Time frame: Up to 1 year post-transplant. Count of participants. Unit: Participants

Measure	Patients With Hematologic Malgnancies n = 33
Value	33

Population analysed: Patients who received total body irradiation

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious AEs collected for up to 100 days post transplant; SAEs and all-cause mortality collected for up to 1 year post transplant. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Hematologic Malgnancies	22 of 33 (66.7%)	19 of 33 (57.6%)	3 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

Related trials for Hematologic Malignancy

RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma

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.

Naamit Gerber, MD principal investigator

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Linac Based VMAT TBI in people with Hematologic Malignancy, run by NYU Langone Health 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 18 inclusion and 5 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: finished, as of the sponsor's last update on 4 May 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Patients Who Achieve Excellent Coverage While Sparing the Lung (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?

On the ClinicalTrials.gov record for NCT04509765.

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 4 May 2026.