Acute Lymphoblastic LeukemiaTMINCT06461091
the Efficacy and Safety of Total Myeloid Irradiation (TMI) in the Treatment of Adult Acute Lymphoblastic Leukemia
An observational study of Acute Lymphoblastic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
Observation of event-free survival, engraftment rate, overall survival (OS), and safety data in patients aged ≥16 years with acute lymphoblastic leukemia (ALL) receiving a conditioning regimen including total marrow irradiation (TMI) followed by allogeneic hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- TMI
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to 30 Apr 2025
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients（ aged ≥16 years） with acute lymphoblastic leukemia (ALL) paining to receive allogeneic hematopoietic stem cell transplantation.
Who may be able to join
- Subjects eligible for inclusion in this study must meet all of the following criteria: (1) Definitive diagnosis of acute lymphoblastic leukemia requiring allogeneic hematopoietic stem cell transplantation. (2) Age greater than or equal to 16 years.
Who cannot join
- Subjects meeting any of the following criteria are not eligible for inclusion in this study: (1) Patients with extramedullary infiltration (excluding central nervous system leukemia). (2) Patients undergoing second transplantation. (3) Patients with concurrent malignancies. (4) Patients with malignancies secondary to a second tumor. (5) Patients assessed by the investigator to have accompanying diseases that are deemed to pose a serious risk to the patient\'s life or interfere with the patient\'s completion of this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Single-arm, Exploratory Clinical Study of the Efficacy and Safety of Total Myeloid Irradiation (TMI) in the Treatment of Adult Acute Lymphoblastic Leukemia
Observation of event-free survival, engraftment rate, overall survival (OS), and safety data in patients aged ≥16 years with acute lymphoblastic leukemia (ALL) receiving a conditioning regimen including total marrow irradiation (TMI) followed by allogeneic hematopoietic stem cell transplantation. Aim to further enhance transplant outcomes in ALL patients based on the existing basis.
Read the detailed description
Observation of event-free survival, engraftment rate, overall survival (OS), and safety data in patients aged ≥16 years with acute lymphoblastic leukemia (ALL) receiving a conditioning regimen including total marrow irradiation (TMI) followed by allogeneic hematopoietic stem cell transplantation. Aim to further enhance transplant outcomes in ALL patients based on the existing basis.Exploratory Endpoint: Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS).Secondary Exploratory Endpoints: (1) Rate of granulocyte and platelet hematopoietic recovery. (2) Incidence of toxicity related to the conditioning regimen.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- TMI
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMIRadiation
Observing the efficacy and safety of allogeneic hematopoietic stem cell transplantation in treating adult acute lymphoblastic leukemia with a conditioning regimen including total marrow irradiation (TMI) in individuals aged 16 years and older: Primary Exploratory Endpoint: Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS).
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS).
Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS).
Measured: 1YEAR
Secondary outcomes (2)
(1) Rate of granulocyte and platelet hematopoietic recovery.
(1) Rate of granulocyte and platelet hematopoietic recovery.
Measured: 1YEAR
(2) Incidence of toxicity related to the conditioning regimen.
(2) Incidence of toxicity related to the conditioning regimen.
Measured: 1YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study startJul 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461091
- Sponsor's protocol ID
- IIT2024023
- Acronym
- TMI
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Exploratory Clinical Study of the Efficacy and Safety of Total Myeloid Irradiation (TMI) in the Treatment of Adult Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06461091
- Acronym / sponsor ID
- TMI / IIT2024023
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 14 Jun 2024 (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.
Observation of event-free survival, engraftment rate, overall survival (OS), and safety data in patients aged ≥16 years with acute lymphoblastic leukemia (ALL) receiving a conditioning regimen including total marrow irradiation (TMI) followed by allogeneic hematopoietic stem cell transplantation. Aim to further enhance transplant outcomes in ALL patients based on the existing basis.
Detailed description
Observation of event-free survival, engraftment rate, overall survival (OS), and safety data in patients aged ≥16 years with acute lymphoblastic leukemia (ALL) receiving a conditioning regimen including total marrow irradiation (TMI) followed by allogeneic hematopoietic stem cell transplantation. Aim to further enhance transplant outcomes in ALL patients based on the existing basis.Exploratory Endpoint: Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS).Secondary Exploratory Endpoints: (1) Rate of granulocyte and platelet hematopoietic recovery. (2) Incidence of toxicity related to the conditioning regimen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients（ aged ≥16 years） with acute lymphoblastic leukemia (ALL) paining to receive allogeneic hematopoietic stem cell transplantation.
Key inclusion criteria (1 listed)
- Subjects eligible for inclusion in this study must meet all of the following criteria: (1) Definitive diagnosis of acute lymphoblastic leukemia requiring allogeneic hematopoietic stem cell transplantation. (2) Age greater than or equal to 16 years.
Key exclusion criteria (1 listed)
- Subjects meeting any of the following criteria are not eligible for inclusion in this study: (1) Patients with extramedullary infiltration (excluding central nervous system leukemia). (2) Patients undergoing second transplantation. (3) Patients with concurrent malignancies. (4) Patients with malignancies secondary to a second tumor. (5) Patients assessed by the investigator to have accompanying diseases that are deemed to pose a serious risk to the patient\'s life or interfere with the patient\'s completion of this 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 |
|---|---|---|
| TMIObserving the efficacy and safety of allogeneic hematopoietic stem cell transplantation in treating adult acute lymphoblastic leukemia with a conditioning regimen including total marrow irradiation (TMI) in individuals aged 16 years and older: Primary Exploratory Endpoint: Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS). | Radiation | – |
Primary outcome
Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS).
Time frame: 1YEAR
Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS).
2 secondary outcomes
(1) Rate of granulocyte and platelet hematopoietic recovery.
Time frame: 1YEAR
(2) Incidence of toxicity related to the conditioning regimen.
Time frame: 1YEAR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, 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 1 inclusion and 1 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 11 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact erlie jiang (+86-15122538106, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS). (time frame: 1YEAR). 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 11 Jul 2024.