Haematological MalignancyNCT03262220
Total Marrow Irradiation With Volumetric Arc Therapy for Patients Unfit for a 12 Gy TBI
A study testing Volumetric Arc Therapy (VMAT) in people with Haematological Malignancy, run by Thomas Zilli at 1 site in Switzerland.
Trial summary
Total body irradiation (TBI) is a standard part of the conditioning regimen for bone marrow transplantation (BMT). Several randomized trials have shown superior outcomes using TBI compared with non TBI-containing regimens. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Haematological Malignancy
- What is being tested?
- Volumetric Arc Therapy (VMAT)
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Apr 2017to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Karnofsky performance status ≥ 70
- Presence of any kind of haematological malignancy in complete remission (CR1, CR2 ore CR3) at time of transplantation, with the exception of patients with myelodysplastic syndrome.
- Patients that are scheduled for a BMT either using stem cell derived from bone marrow or peripheral blood stem cells.
- Candidates to receive a 10 Gy TBI treatment.
- Ability to stay still and lying on the treatment couch for at least 45 minutes.
- Informed Consent as documented by signature.
Who cannot join
- Karnofsky performance status <70 intended as a patient unable to work; able to live at home and care for most personal needs with varying amount of assistance needed.
- Concurrent treatment with other experimental drugs or other anti-cancer therapy.
- Participation in another clinical trial and any concurrent treatment with any investigational drug within 4 weeks prior to trial entry/randomisation.
- Inability to comply with study and follow-up procedures.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Geneva
Geneva, 1205
Thomas Zilli, MD, +41 79 55 32 563, thomas.zilli@hcuge.ch
Giorgio Lamana, MD
About this study
Official title: Pilot Study of Dose Escalated Total Marrow Irradiation With Volumetric Arc Therapy for Patients With Hematological Malignancies Unfit for a Standard 12 Gy TBI Conditioning Regimen.
Total body irradiation (TBI) is a standard part of the conditioning regimen for bone marrow transplantation (BMT). Several randomized trials have shown superior outcomes using TBI compared with non TBI-containing regimens. Standard TBI is usually delivered over three days for a total dose of 12 Gy with two daily fractions. However, as demonstrated by our group, increasing the TBI dose above 10 Gy is not necessarily associated with better outcome in patients undergoing allogenic BMT for hematologic malignancies. For this reason, patients older than 40 or grafted after relapse are treated at our center with a reduced-dose 10 Gy TBI regimen. This pilot study wishes to investigate in 10 patients with hematological malignancies unfit for a standard 12 Gy TBI conditioning regimen a more targeted, conformal form of treatment, referred as total marrow (TMI), using volumetric Arc Therapy (VMAT). Our hypothesis is that using this technique that can allow deliver a higher total dose to the target while at the same time assuring to the organs at risk (OAR) the same dose normally delivered with a 10 Gy TBI we will improve the therapeutic ratio in these patients.
Read the detailed description
This is a feasibility prospective pilot study. Ten patients ≥ 40 years with hematologic malignancies prior to Bone Marrow Transplant (BMT) will receive a dose escalated hypofractionated Total Marrow Irradiation (TMI) (12 Gy in 3 fractions, daily, on 3 consecutive days).
The current project is a joint initiative in translational and clinical medical research between the Radiation-oncology workgroup and the Bone Marrow transplant workgroup of University Hospitals of Geneva (HUG).
- Conditions
- Haematological Malignancy
- Being tested
- Volumetric Arc Therapy (VMAT)
- Keywords
- Haematological malignancy, Total Marrow Irradiation, Volumetric Arc Therapy
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volumetric Arc Therapy (VMAT)Radiation
Total Marrow Irradiation: 12 Gy in 3 fractions of 4 Gy on 3 consecutive days with a concomitant simultaneous integrated boost (SIB) of 4.5 Gy x 3 fractions delivered to active bone marrow (ABM).
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade II and III toxicity
(Seattle Regimen-related toxicity grade) 30 days after transplant in patients with hematologic malignancies treated with a dose-escalated hypofractionated VMAT-based TMI
Measured: 30 days after radiotherapy
Secondary outcomes (2)
Cumulative incidence of Transplant Related Mortality(TRM)
Defined as death occurring from causes that are different other than disease relapse post-transplant
Measured: 100 days post-bone marrow transplantation
Cumulative incidence of Grade II Organ toxicity
Seattle Regimen-related toxicity grade
Measured: up to day 100 post-bone marrow transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start11 Apr 2017
- Primary completionApr 2021 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haematological MalignancyStudies of the same condition, open and under way.
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Zilli
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor-investigator, Thomas Zilli, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262220
- Sponsor's protocol ID
- 2017-00066
- Other IDs
- 2017
- Status last verified
- May 2020
- First submitted
- 23 Aug 2017
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Dose Escalated Total Marrow Irradiation With Volumetric Arc Therapy for Patients With Hematological Malignancies Unfit for a Standard 12 Gy TBI Conditioning Regimen.
- ClinicalTrials.gov ID
- NCT03262220
- Acronym / sponsor ID
- 2017-00066
- Conditions
- Haematological Malignancy
- Keywords
- Haematological malignancy, Total Marrow Irradiation, Volumetric Arc Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Thomas ZilliUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 25 Aug 2017 (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.
Total body irradiation (TBI) is a standard part of the conditioning regimen for bone marrow transplantation (BMT). Several randomized trials have shown superior outcomes using TBI compared with non TBI-containing regimens. Standard TBI is usually delivered over three days for a total dose of 12 Gy with two daily fractions. However, as demonstrated by our group, increasing the TBI dose above 10 Gy is not necessarily associated with better outcome in patients undergoing allogenic BMT for hematologic malignancies. For this reason, patients older than 40 or grafted after relapse are treated at our center with a reduced-dose 10 Gy TBI regimen. This pilot study wishes to investigate in 10 patients with hematological malignancies unfit for a standard 12 Gy TBI conditioning regimen a more targeted, conformal form of treatment, referred as total marrow (TMI), using volumetric Arc Therapy (VMAT). Our hypothesis is that using this technique that can allow deliver a higher total dose to the target while at the same time assuring to the organs at risk (OAR) the same dose normally delivered with a 10 Gy TBI we will improve the therapeutic ratio in these patients.
Detailed description
This is a feasibility prospective pilot study. Ten patients ≥ 40 years with hematologic malignancies prior to Bone Marrow Transplant (BMT) will receive a dose escalated hypofractionated Total Marrow Irradiation (TMI) (12 Gy in 3 fractions, daily, on 3 consecutive days).
The current project is a joint initiative in translational and clinical medical research between the Radiation-oncology workgroup and the Bone Marrow transplant workgroup of University Hospitals of Geneva (HUG).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Karnofsky performance status ≥ 70
- Presence of any kind of haematological malignancy in complete remission (CR1, CR2 ore CR3) at time of transplantation, with the exception of patients with myelodysplastic syndrome.
- Patients that are scheduled for a BMT either using stem cell derived from bone marrow or peripheral blood stem cells.
- Candidates to receive a 10 Gy TBI treatment.
- Ability to stay still and lying on the treatment couch for at least 45 minutes.
Key exclusion criteria (4 listed)
- Karnofsky performance status <70 intended as a patient unable to work; able to live at home and care for most personal needs with varying amount of assistance needed.
- Concurrent treatment with other experimental drugs or other anti-cancer therapy.
- Participation in another clinical trial and any concurrent treatment with any investigational drug within 4 weeks prior to trial entry/randomisation.
- Inability to comply with study and follow-up procedures.
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 |
|---|---|---|
| Volumetric Arc Therapy (VMAT)Total Marrow Irradiation: 12 Gy in 3 fractions of 4 Gy on 3 consecutive days with a concomitant simultaneous integrated boost (SIB) of 4.5 Gy x 3 fractions delivered to active bone marrow (ABM). | Radiation | – |
Primary outcome
Grade II and III toxicity
Time frame: 30 days after radiotherapy
(Seattle Regimen-related toxicity grade) 30 days after transplant in patients with hematologic malignancies treated with a dose-escalated hypofractionated VMAT-based TMI
2 secondary outcomes
Cumulative incidence of Transplant Related Mortality(TRM)
Time frame: 100 days post-bone marrow transplantation
Cumulative incidence of Grade II Organ toxicity
Time frame: up to day 100 post-bone marrow transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Individual participant dataSharing planned: No. No plan
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volumetric Arc Therapy (VMAT) in people with Haematological Malignancy, run by Thomas Zilli at 1 site in Switzerland.
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 6 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: status not confirmed, as of the sponsor's last update on 14 May 2020. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Zilli, MD (+ 41 79 55 32 563, thomas.zilli@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade II and III toxicity (time frame: 30 days after radiotherapy). 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 14 May 2020.