HSCTNCT07456189
The Efficacy and Safety of Stereotactic Radiotherapy Bridging Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Hematological Malignance Patients With Extramedullary Infiltrating
A study testing Stereotactic body radiotherapy (SBRT) in people with HSCT and Hematologic Cancer, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
Application of Stereotactic Body Radiotherapy (SBRT) Bridging to Allogeneic Hematopoietic Stem Cell Transplantation in Adult Hematological Malignance Patients with Extramedullary Lesions. This study aims to improve transplantation outcomes with extramedullary lesions. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HSCT, Hematologic Cancer
- What is being tested?
- Stereotactic body radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2026to 1 Mar 2028
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who meet all of the following criteria are eligible for enrollment in this study:
- Age between 18 and 60 years.
- A confirmed diagnosis of a hematologic malignancy, including but not limited to Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Chronic Myeloid Leukemia (CML), Myelodysplastic Syndromes (MDS), Non-Hodgkin Lymphoma (NHL), Hodgkin Lymphoma (HL), and Multiple Myeloma (MM).
- Diagnosis of extramedullary disease/lesions confirmed by one of the following: pathological biopsy, cytology, or at least one imaging modality (including PET-CT, contrast-enhanced CT, or contrast-enhanced MRI).
- Presence of a suitable donor and scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Karnofsky Performance Status (KPS) score > 60% or Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2.
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- Has not participated in any other clinical trial involving cell-based or immunotherapies for the treatment of the primary disease.
- The subject voluntarily agrees to participate in the study, demonstrates good compliance, and is willing to cooperate with follow-up procedures.
- A signed informed consent form must be obtained prior to the initiation of any study-related procedures. For subjects aged 18 years or older, consent is to be provided by the subject or their immediate family member. If, in the physician's judgment, obtaining consent directly from the subject is not in the patient's best interest regarding their medical condition, the informed consent form may be signed by the legal guardian or an immediate family member of the patient
Who cannot join
- Previous history of one or more autologous or allogeneic stem cell transplants prior to enrollment.
- Uncontrolled infection at the time of enrollment, or requirement for mechanical ventilatory assistance, or hemodynamic instability.
- Severe organ dysfunction, including but not limited to hepatic or renal impairment, and heart failure.
- Evidence of active HIV replication; positive HCV antibody and detectable HCV-RNA within 90 days prior to enrollment; or positive HBsAg. Known seropositivity for HIV or active hepatitis C virus.
- Presence of psychiatric disorders or any other condition that, in the investigator's opinion, would compromise the subject's ability to cooperate with study treatment and monitoring requirements.
- Inability or unwillingness to provide written informed consent.
- Any other condition or circumstance that, in the judgment of the investigator, may pose a risk to the subject or prevent the subject from meeting or fulfilling the study requirements.
About this study
Application of Stereotactic Body Radiotherapy (SBRT) Bridging to Allogeneic Hematopoietic Stem Cell Transplantation in Adult Hematological Malignance Patients with Extramedullary Lesions. This study aims to improve transplantation outcomes with extramedullary lesions. The investigators aim to study the Post-Transplantation Evaluation of Disease-Free Survival, Overall Survival, Treatment-Related Mortality, Cumulative Recurrence Rate, Post-Transplantation Complications, and Safety Data.
- Conditions
- HSCT, Hematologic Cancer
- Being tested
- Stereotactic body radiotherapy (SBRT)
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiotherapy (SBRT)Radiation
Stereotactic Body Radiotherapy (SBRT) before bridging to HSCT
| Study group | Role | What they receive |
|---|---|---|
| SBRT+HSCT | Experimental | participants in this arm recieve the treatment of SBRT before bridging to HSCT Receives: Radiation: Stereotactic body radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: one year
Secondary outcomes (5)
relapse free survival
Measured: one year
cumulative incidence of relapse
Measured: one year
treatment related mortality
Measured: one year
Extramedullary disease evaluation (RECIST v1.1)
Measured: one year
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start14 Apr 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HSCTStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456189
- Sponsor's protocol ID
- IIT2026010
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Stereotactic Radiotherapy Bridging Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Hematological Malignance Patients With Extramedullary Infiltrating
- ClinicalTrials.gov ID
- NCT07456189
- Acronym / sponsor ID
- IIT2026010
- Conditions
- HSCT, Hematologic Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 14 Apr 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 6 Mar 2026 (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.
Application of Stereotactic Body Radiotherapy (SBRT) Bridging to Allogeneic Hematopoietic Stem Cell Transplantation in Adult Hematological Malignance Patients with Extramedullary Lesions. This study aims to improve transplantation outcomes with extramedullary lesions. The investigators aim to study the Post-Transplantation Evaluation of Disease-Free Survival, Overall Survival, Treatment-Related Mortality, Cumulative Recurrence Rate, Post-Transplantation Complications, and Safety Data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT+HSCT | Experimental | Radiation: Stereotactic body radiotherapy (SBRT)participants in this arm recieve the treatment of SBRT before bridging to HSCT |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subjects who meet all of the following criteria are eligible for enrollment in this study:
- Age between 18 and 60 years.
- A confirmed diagnosis of a hematologic malignancy, including but not limited to Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Chronic Myeloid Leukemia (CML), Myelodysplastic Syndromes (MDS), Non-Hodgkin Lymphoma (NHL), Hodgkin Lymphoma (HL), and Multiple Myeloma (MM).
- Diagnosis of extramedullary disease/lesions confirmed by one of the following: pathological biopsy, cytology, or at least one imaging modality (including PET-CT, contrast-enhanced CT, or contrast-enhanced MRI).
- Presence of a suitable donor and scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Key exclusion criteria (7 listed)
- Previous history of one or more autologous or allogeneic stem cell transplants prior to enrollment.
- Uncontrolled infection at the time of enrollment, or requirement for mechanical ventilatory assistance, or hemodynamic instability.
- Severe organ dysfunction, including but not limited to hepatic or renal impairment, and heart failure.
- Evidence of active HIV replication; positive HCV antibody and detectable HCV-RNA within 90 days prior to enrollment; or positive HBsAg. Known seropositivity for HIV or active hepatitis C virus.
- Presence of psychiatric disorders or any other condition that, in the investigator's opinion, would compromise the subject's ability to cooperate with study treatment and monitoring requirements.
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 |
|---|---|---|
| Stereotactic body radiotherapy (SBRT)Stereotactic Body Radiotherapy (SBRT) before bridging to HSCT | Radiation | SBRT+HSCT |
Primary outcome
Overall Survival
Time frame: one year
5 secondary outcomes
relapse free survival
Time frame: one year
cumulative incidence of relapse
Time frame: one year
treatment related mortality
Time frame: one year
Extramedullary disease evaluation (RECIST v1.1)
Time frame: one year
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: one 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 6 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic body radiotherapy (SBRT) in people with HSCT and Hematologic Cancer, run by Institute of Hematology & Blood Diseases Hospital, China.
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 9 inclusion and 7 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: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Overall Survival (time frame: one year). 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 6 Mar 2026.