Aplastic AnaemiaPhase 2NCT06769568
Reduced-dose Conditioning Regimen Containing TBI in HSCT Treating Elderly Patients With Aplastic Anemia
A Phase 2 study testing reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating elderly patients with aplastic anemia in people with Aplastic Anaemia and HSCT, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
The TBI-containing reduced-dose conditioning regimen was used to treat elderly patients with aplastic anemia who received hematopoietic stem cell transplantation. The overall survival rate, GVHD-free survival rate, all-cause mortality,et al were studied. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aplastic Anaemia, HSCT, TBI
- What is being tested?
- reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating elderly patients with aplastic anemia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2025to 30 Sep 2028
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ( 1 ) Diagnosis of aplastic anemia, including very severe aplastic anemia, severe aplastic anemia, chronic aplastic anemia and hepatitis-associated aplastic anemia.
- ( 2 ) Age older than or equal to 50 years old. ( 3 ) Informed consent can be signed by themselves. ( 4 ) HIV negative, HBV, HCV negative. ( 5 ) Informed consent must be signed before the start of the study procedure. Informed consent must be signed by the patient or immediate family members who are 18 years old or older. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent is signed by the legal guardian or the patient 's immediate family.
Who cannot join
- ( 1 ) Patients who underwent more than one time of transplantation before enrollment ; ( 2 ) Uncontrolled infection, mechanical ventilation or hemodynamic instability at the time of enrollment ; ( 3 ) Diagnosis of clinically significant severe liver dysfunction ( defined as Child-Pugh C grade ) within 5 days before enrollment ; or within 5 days before enrollment, AST or ALT was 5 times higher than the upper limit of normal, or serum total bilirubin was 2 times higher than the upper limit of normal ; ( 4 ) End-stage renal insufficiency was diagnosed within 5 days before enrollment, and creatinine clearance rate was less than 10ML / min.
- ( 5 ) Simultaneous diagnosis of moderate hepatic insufficiency and moderate renal insufficiency ( moderate hepatic insufficiency was defined as Child-Pugh B grade ; moderate renal insufficiency was defined as creatinine clearance rate less than 50ML / min ).
- ( 6 ) In addition to localized basal cell or squamous cell skin cancer or treatment conditions ( such as lymphoma ), there are active solid tumor malignant tumors.
- ( 7 ) There was active HIV replication before enrollment. HCV antibody positive, HCV-RNA positive, or HBsAg positive could be detected within 90 days before enrollment. The serological response to HIV or active hepatitis C virus is known to be positive.
- ( 8 ) Having a mental illness or other condition that does not cooperate with the requirements of research, treatment and monitoring.
- ( 9 ) unable or unwilling to sign the consent form. ( 10 ) Patients with other special conditions who were assessed as unqualified by the researchers.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Xiaoyu Zhang contact
About this study
Official title: The Safety and Efficacy of Reduced-dose Conditioning Regimen Containing TBI in Hematopoietic Stem Cell Transplantation Treating Elderly Patients With Aplastic Anemia
The TBI-containing reduced-dose conditioning regimen was used to treat elderly patients with aplastic anemia who received hematopoietic stem cell transplantation. The overall survival rate, GVHD-free survival rate, all-cause mortality,et al were studied. The modified conditioning regimen included TBI 2Gy, -7d, busulfan 3.2mg / kg-6d ; fludarabine 30mg / m2 / d-5 ~ -1d ; cyclophosphamide 25-30mg / kg / d-5 ~ -2d ; ATG ( rabbit ) 2 mg / kg / d-5 ~ -1d.
- Conditions
- Aplastic Anaemia, HSCT, TBI, Old Age
- Being tested
- reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating elderly patients with aplastic anemia
- Keywords
- aplastic anemia, HSCT, old age, conditioning regimen
- Medical subject headings
- Anemia, Aplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating elderly patients with aplastic anemiaDrug
reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating elderly patients with aplastic anemia
| Study group | Role | What they receive |
|---|---|---|
| reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating | Experimental | reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating elderly patients with aplastic anemia Receives: Drug: reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating elderly patients with aplastic anemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
2-year overall survival
Measured: 2 year after HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start31 Jan 2025 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aplastic AnaemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769568
- Sponsor's protocol ID
- IIT2024078
- Status last verified
- Dec 2024
- First submitted
- 23 Oct 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Reduced-dose Conditioning Regimen Containing TBI in Hematopoietic Stem Cell Transplantation Treating Elderly Patients With Aplastic Anemia
- ClinicalTrials.gov ID
- NCT06769568
- Acronym / sponsor ID
- IIT2024078
- Conditions
- Aplastic Anaemia, HSCT, TBI, Old Age
- Keywords
- aplastic anemia, HSCT, old age, conditioning regimen
- Phase
- Phase 2
- 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
- 31 Jan 2025 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 10 Jan 2025 (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.
The TBI-containing reduced-dose conditioning regimen was used to treat elderly patients with aplastic anemia who received hematopoietic stem cell transplantation. The overall survival rate, GVHD-free survival rate, all-cause mortality,et al were studied. The modified conditioning regimen included TBI 2Gy, -7d, busulfan 3.2mg / kg-6d ; fludarabine 30mg / m2 / d-5 ~ -1d ; cyclophosphamide 25-30mg / kg / d-5 ~ -2d ; ATG ( rabbit ) 2 mg / kg / d-5 ~ -1d.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating | Experimental | Drug: reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating elderly patients with aplastic anemiareduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating elderly patients with aplastic anemia |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ( 1 ) Diagnosis of aplastic anemia, including very severe aplastic anemia, severe aplastic anemia, chronic aplastic anemia and hepatitis-associated aplastic anemia.
- ( 2 ) Age older than or equal to 50 years old. ( 3 ) Informed consent can be signed by themselves. ( 4 ) HIV negative, HBV, HCV negative. ( 5 ) Informed consent must be signed before the start of the study procedure. Informed consent must be signed by the patient or immediate family members who are 18 years old or older. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent is signed by the legal guardian or the patient 's immediate family.
Key exclusion criteria (6 listed)
- ( 1 ) Patients who underwent more than one time of transplantation before enrollment ; ( 2 ) Uncontrolled infection, mechanical ventilation or hemodynamic instability at the time of enrollment ; ( 3 ) Diagnosis of clinically significant severe liver dysfunction ( defined as Child-Pugh C grade ) within 5 days before enrollment ; or within 5 days before enrollment, AST or ALT was 5 times higher than the upper limit of normal, or serum total bilirubin was 2 times higher than the upper limit of normal ; ( 4 ) End-stage renal insufficiency was diagnosed within 5 days before enrollment, and creatinine clearance rate was less than 10ML / min.
- ( 5 ) Simultaneous diagnosis of moderate hepatic insufficiency and moderate renal insufficiency ( moderate hepatic insufficiency was defined as Child-Pugh B grade ; moderate renal insufficiency was defined as creatinine clearance rate less than 50ML / min ).
- ( 6 ) In addition to localized basal cell or squamous cell skin cancer or treatment conditions ( such as lymphoma ), there are active solid tumor malignant tumors.
- ( 7 ) There was active HIV replication before enrollment. HCV antibody positive, HCV-RNA positive, or HBsAg positive could be detected within 90 days before enrollment. The serological response to HIV or active hepatitis C virus is known to be positive.
- ( 8 ) Having a mental illness or other condition that does not cooperate with the requirements of research, treatment and monitoring.
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 |
|---|---|---|
| reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating elderly patients with aplastic anemiareduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating elderly patients with aplastic anemia | Drug | reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating |
Primary outcome
overall survival
Time frame: 2 year after HSCT
2-year overall survival
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 10 Jan 2025.
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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.
Xiaoyu Zhang contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating elderly patients with aplastic anemia in people with Aplastic Anaemia and HSCT, 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 2 inclusion and 6 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 10 Jan 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
overall survival (time frame: 2 year after HSCT). 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 10 Jan 2025.