Leukemia, LymphoidNCT06075212
Immune Reconstitution After Allo-HSCT and Blinatumomab
An observational study of Leukemia, Lymphoid, run by Sichuan University.
Trial summary
The goal of this observation study is to test in relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Leukemia, Lymphoid
- What is being tested?
- blinatumomab
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 30 Sep 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT).
Who may be able to join
- Aged 16-65 years old
- KPS score > 60 or ECOG score 0-2
- diagnosed as B-ALL, a) disease status > CR1 at the time of transplantation; Patients beyond CR1 or induction failure could be free of minimal residual disease (MRD). b) any residual disease, defined as >0.01% leukemic cells by flow cytometry, BCR-ABL transcript ≥ 1 in 10000 by PCR, or high-risk genetic abnormality
- neutrophil count ≥0.5×10^9/L and platelet count ≥20×10^9/L
- creatinine clearance ≥30ml/min; Alanine aminotransferase/aspartate aminotransferase ≤5 times the upper detection limit; Total bilirubin ≤3 times the upper limit of detection
- The first initiation of berintuzumab therapy was within 60-100 days after transplantation
- without evidence of active acute graft-versus-host disease (aGvHD)
Who cannot join
- With serious basic diseases of important organs, such as myocardial infarction, chronic cardiac insufficiency, decompensated liver dysfunction, renal dysfunction, gastrointestinal dysfunction, etc
- With clinically uncontrolled active infection
- Patients with central nervous system involvement before transplantation
- Poor graft function (PGF) occurred after allo-HSCT
- Patients with second allogeneic transplantation
About this study
Official title: Immune Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation With Post-transplant Blinatumomab Maintenance Treatment
The goal of this observation study is to test in relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:
- Effect of post-transplant blinatumomab treatment on immune reconstitution after transplantation.
Participants will undergo immune repertoire sequencing(IR-SEQ) before blinatumomab treatment, 6 months and 1 year after transplantation.
Researchers will compare patients who don't receive blinatumomab treatment after transplantation to see if TCR or BCR expression differs.
- Conditions
- Leukemia, Lymphoid
- Being tested
- blinatumomab
- Medical subject headings
- Leukemia, Lymphoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blinatumomabDrug
The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.
| Study group | Role | What they receive |
|---|---|---|
| Blin-PTCY | Post-transplant cyclophosphamide is used as graft versus host disease (GvHD) prophylaxis. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Receives: Drug: blinatumomab | |
| Blin-ATG | Antithymocyte globulin is used as graft versus host disease (GvHD) prophylaxis. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Receives: Drug: blinatumomab | |
| Control | Patients don't take blinatumomab treatment after transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
T cell receptor expression
T cell receptor expression measured by Immune Repertoire sequencing(IR-SEQ)
Measured: before blinatumomab treatment , 6 months and 1 year
B cell receptor expression
B cell receptor expression measured by Immune Repertoire sequencing(IR-SEQ)
Measured: before blinatumomab treatment , 6 months and 1 year
Secondary outcomes (1)
T cell subsets count
T cell subsets count including CD3+, CD4+, CD8+, CD19+, Treg, memory and cytotoxic T cells
Measured: before blinatumomab treatment , 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Oct 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, LymphoidStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Ji, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075212
- Sponsor's protocol ID
- Blin-immune 1.0
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- 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 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation With Post-transplant Blinatumomab Maintenance Treatment
- ClinicalTrials.gov ID
- NCT06075212
- Acronym / sponsor ID
- Blin-immune 1.0
- Conditions
- Leukemia, Lymphoid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 10 Oct 2023 (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 goal of this observation study is to test in relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:
- Effect of post-transplant blinatumomab treatment on immune reconstitution after transplantation.
Participants will undergo immune repertoire sequencing(IR-SEQ) before blinatumomab treatment, 6 months and 1 year after transplantation.
Researchers will compare patients who don't receive blinatumomab treatment after transplantation to see if TCR or BCR expression differs.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blin-PTCY | – | Drug: blinatumomabPost-transplant cyclophosphamide is used as graft versus host disease (GvHD) prophylaxis. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. |
| Blin-ATG | – | Drug: blinatumomabAntithymocyte globulin is used as graft versus host disease (GvHD) prophylaxis. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. |
| Control | – | –Patients don't take blinatumomab treatment after transplantation. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT).
Key inclusion criteria (7 listed)
- Aged 16-65 years old
- KPS score > 60 or ECOG score 0-2
- diagnosed as B-ALL, a) disease status > CR1 at the time of transplantation; Patients beyond CR1 or induction failure could be free of minimal residual disease (MRD). b) any residual disease, defined as >0.01% leukemic cells by flow cytometry, BCR-ABL transcript ≥ 1 in 10000 by PCR, or high-risk genetic abnormality
- neutrophil count ≥0.5×10^9/L and platelet count ≥20×10^9/L
- creatinine clearance ≥30ml/min; Alanine aminotransferase/aspartate aminotransferase ≤5 times the upper detection limit; Total bilirubin ≤3 times the upper limit of detection
Key exclusion criteria (5 listed)
- With serious basic diseases of important organs, such as myocardial infarction, chronic cardiac insufficiency, decompensated liver dysfunction, renal dysfunction, gastrointestinal dysfunction, etc
- With clinically uncontrolled active infection
- Patients with central nervous system involvement before transplantation
- Poor graft function (PGF) occurred after allo-HSCT
- Patients with second allogeneic transplantation
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 |
|---|---|---|
| blinatumomabThe dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events. | Drug | Blin-ATG, Blin-PTCY |
Primary outcome
T cell receptor expression
Time frame: before blinatumomab treatment , 6 months and 1 year
T cell receptor expression measured by Immune Repertoire sequencing(IR-SEQ)
B cell receptor expression
Time frame: before blinatumomab treatment , 6 months and 1 year
B cell receptor expression measured by Immune Repertoire sequencing(IR-SEQ)
1 secondary outcome
T cell subsets count
Time frame: before blinatumomab treatment , 6 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Lymphoid, run by Sichuan University.
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 7 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: status not confirmed, as of the sponsor's last update on 10 Oct 2023. 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?
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?
T cell receptor expression (time frame: before blinatumomab treatment , 6 months and 1 year). The study lists 2 primary outcomes in all. 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 Oct 2023.