High-Risk Acute Myeloid LeukemiaDonor choseNCT06686173
Effect of Donor Chose on the Outcomes of GVHD Prophylaxis Underwent the Combined Treatment of ATG/PTCy for Haplo-HSCT
An observational study of High-Risk Acute Myeloid Leukemia and Relapse And/or Refractory AML, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
This is a prospective, multicenter, cohort study. The high-risk, relapse and refractory AML patients were enrolled in this study. And the goal of this study is to study the effect of the parous female donor and young male donor on the outcomes of graft-versus-host disease (GVHD) prophylaxis underwent the combination… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- High-Risk Acute Myeloid Leukemia, Relapse And/or Refractory AML
- What is being tested?
- non-intervention study and donor selection
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Feb 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: The high-risk, relapse and refractory AML patients were enrolled in this study
Who may be able to join
- 1. Acute myeloid leukemia was diagnosed according to the 2016ELN criteria with any of the following:
- ELN prognostic stratification high-risk group (see Appendix for criteria)
- Non-remission (NR) AML: including primary refractory AML and NR patients after relapse.
- 2. Patients must have a suitable hematopoietic stem-cell donor.
- Patients had to have a qualified haploidentical young male (≤30 years old) or female with a history of pregnancy;
- Related donors had to be related donors matched 5/10-7/10 for HLA-A, -B, -C, -DQB1 and -DRB1 3. All the enrolled patients received a unified GVHD prevention regimen based on ATG and PTCy
Who cannot join
- Intermediate-low risk AML patients (ELN criteria);
- Patients with extramedullary active lesions at the time of transplantation;
- Haploidentical collateral donors;
- Patients who refused allogeneic hematopoietic stem cell transplantation;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of the Parous Female and Young Male Donor on the Outcomes of GVHD Prophylaxis Underwent the Combined Treatment of ATG and PTCy for Haplo-HSCT: a Prospective, Multi-center, Cohort Study
This is a prospective, multicenter, cohort study. The high-risk, relapse and refractory AML patients were enrolled in this study. And the goal of this study is to study the effect of the parous female donor and young male donor on the outcomes of graft-versus-host disease (GVHD) prophylaxis underwent the combination of ATG and PTCy for haploidentical peripheral blood stem cell transplantation
- Being tested
- None-placebo, non-intervention study, donor selection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None-placeboOther
This is one kind descriptive study. The different donor groups made the cohorts different: the parous female donor and young male donor
non-intervention studyOther
This study is one kind of non intervention study
donor selectionOther
the intervention of this study was the different donor groups: the parous female donor and young male donor. All the patients involved in this study were treated by the combination of ATG and PTCy
What is being measured
The primary outcome is the main question the study is designed to answer.
RFS
1-year RFS after transplantation
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 posted13 Nov 2024
- Study start1 Feb 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Risk Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- 114 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686173
- Sponsor's protocol ID
- SHSYXY-haplo-PBSCT-donor
- Acronym
- Donor chose
- Status last verified
- Jan 2025
- First submitted
- 11 Nov 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Parous Female and Young Male Donor on the Outcomes of GVHD Prophylaxis Underwent the Combined Treatment of ATG and PTCy for Haplo-HSCT: a Prospective, Multi-center, Cohort Study
- ClinicalTrials.gov ID
- NCT06686173
- Acronym / sponsor ID
- Donor chose / SHSYXY-haplo-PBSCT-donor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 13 Nov 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.
This is a prospective, multicenter, cohort study. The high-risk, relapse and refractory AML patients were enrolled in this study. And the goal of this study is to study the effect of the parous female donor and young male donor on the outcomes of graft-versus-host disease (GVHD) prophylaxis underwent the combination of ATG and PTCy for haploidentical peripheral blood stem cell transplantation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The high-risk, relapse and refractory AML patients were enrolled in this study
Key inclusion criteria (6 listed)
- 1. Acute myeloid leukemia was diagnosed according to the 2016ELN criteria with any of the following:
- ELN prognostic stratification high-risk group (see Appendix for criteria)
- Non-remission (NR) AML: including primary refractory AML and NR patients after relapse.
- 2. Patients must have a suitable hematopoietic stem-cell donor.
- Patients had to have a qualified haploidentical young male (≤30 years old) or female with a history of pregnancy;
Key exclusion criteria (4 listed)
- Intermediate-low risk AML patients (ELN criteria);
- Patients with extramedullary active lesions at the time of transplantation;
- Haploidentical collateral donors;
- Patients who refused allogeneic hematopoietic stem cell 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 |
|---|---|---|
| None-placeboThis is one kind descriptive study. The different donor groups made the cohorts different: the parous female donor and young male donor | Other | – |
| non-intervention studyThis study is one kind of non intervention study | Other | – |
| donor selectionthe intervention of this study was the different donor groups: the parous female donor and young male donor. All the patients involved in this study were treated by the combination of ATG and PTCy | Other | – |
Primary outcome
RFS
Time frame: one year
1-year RFS after transplantation
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 7 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.
Questions about this trial
What is this clinical trial studying?
An observational study of High-Risk Acute Myeloid Leukemia and Relapse And/or Refractory AML, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
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: opening soon, as of the sponsor's last update on 7 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.
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 xia shao (15216632623, maizidemaidi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RFS (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 7 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.