Relapse Rate After Allo-HSCTPhase 2NCT04269811
Flu-Bu-Mel Conditioning Regimen for Myeloid Disease
A Phase 2 study testing Flu-Bu-Mel in people with Relapse Rate After Allo-HSCT, run by Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial summary
For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be 5-day Fludarabine, 2-day Busulifan and 2-day melphalan Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Relapse Rate After Allo-HSCT
- What is being tested?
- Flu-Bu-Mel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesChina
- Study dates
- 15 Jan 2020to 30 Jun 2023
- Phase
- Phase 2
- 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
Who may be able to join
- acute myeloid leukemia (CR1 or CR2) or myelodysplasia syndrome
- patients with HLA matched sibling, unrelated or Haplo-identical donor
Who cannot join
- patients with active infection
- patients with abnormal liver function damage: ALT/AST above 2X normal range
- patients with abnormal renal function damage Scr>160µmol/L;
- patients with insufficient pulmonary function (FEV1，FVC，DLCO<50%）and heart failure or with EF <50%)
- patients with mental instability or unwilling to give inform consent
Trial locations and contacts
2 sites in 1 country.
China2 sites
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, 200025
Shanghai No6 Hospital
Shanghai
About this study
Official title: Phase II Study ofFlu-Bu-Mel Conditioning Regimen for Patients With Myeloid Disease Undergoing Allogeneic Stem Cell Transplantation
For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be 5-day Fludarabine, 2-day Busulifan and 2-day melphalan
Read the detailed description
For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be Fludarabine (30mg/m2, d-7 to d-3) + Busulifan 3.2mg/kg (d-7 to d-6) + melphalan 70mg/m2 (d-4 and d-3). The GVHD prophylaxis will be PT-CY (Cyclophosphamide 50mg/kg d+3 and d+4) + low-dose ATG (2.5mg/kg) on d+15.
- Conditions
- Relapse Rate After Allo-HSCT
- Being tested
- Flu-Bu-Mel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flu-Bu-MelDrug
5-day fludarabine + 2-day busulfan (3.2mg/kg) + 2-day melphalan (50-70mg/m2)
| Study group | Role | What they receive |
|---|---|---|
| Flu-Bu-Mel | Experimental | Fludarabine 150mg/m2 + Busulfan 3.2mg/kg 2 days + melphalan 50-70mg/m2 Receives: Drug: Flu-Bu-Mel |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival (DFS)
From transplantation to documentation of death or relapse or progression
Measured: 1 year after transplantation
Secondary outcomes (6)
Overall survival (OS)
From transplantation to documentation of death due to any causes
Measured: 1 year after transplantation
Relapse rate
From transplantation to documentation of relapse or progression
Measured: 1 year after transplantation
non-relapse mortality (NRM)
From transplantation to documentation of death not due to disease relapse or progression
Measured: 1 year after transplantation
acute graft versus host disease (aGVHD)
Incidence of documented grade II-IV acute GVHD
Measured: day 180 after transplantation
chronic graft versus host disease (cGVHD)
Incidence of documented moderate to severe chronic GVHD
Measured: 1 year after transplantation
relapse free survival (GRFS)
From transplantation to documentation of death, III-IV aGVHD, moderate to severe chronic GVHD and relapse
Measured: 1 year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start15 Jan 2020
- Primary completion30 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapse Rate After Allo-HSCTStudies of the same condition, open and under way.
- More trials run by 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiong HU, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jion HU, Principal investigator, Head BMT program, Rui Jin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269811
- Sponsor's protocol ID
- RJH-Myeloid-2020
- Status last verified
- Oct 2023
- First submitted
- 12 Feb 2020
- Last updated
- 25 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 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study ofFlu-Bu-Mel Conditioning Regimen for Patients With Myeloid Disease Undergoing Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04269811
- Acronym / sponsor ID
- RJH-Myeloid-2020
- Conditions
- Relapse Rate After Allo-HSCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 17 Feb 2020 (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.
For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be 5-day Fludarabine, 2-day Busulifan and 2-day melphalan
Detailed description
For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be Fludarabine (30mg/m2, d-7 to d-3) + Busulifan 3.2mg/kg (d-7 to d-6) + melphalan 70mg/m2 (d-4 and d-3). The GVHD prophylaxis will be PT-CY (Cyclophosphamide 50mg/kg d+3 and d+4) + low-dose ATG (2.5mg/kg) on d+15.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flu-Bu-Mel | Experimental | Drug: Flu-Bu-MelFludarabine 150mg/m2 + Busulfan 3.2mg/kg 2 days + melphalan 50-70mg/m2 |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- acute myeloid leukemia (CR1 or CR2) or myelodysplasia syndrome
- patients with HLA matched sibling, unrelated or Haplo-identical donor
Key exclusion criteria (5 listed)
- patients with active infection
- patients with abnormal liver function damage: ALT/AST above 2X normal range
- patients with abnormal renal function damage Scr>160µmol/L;
- patients with insufficient pulmonary function (FEV1，FVC，DLCO<50%）and heart failure or with EF <50%)
- patients with mental instability or unwilling to give inform consent
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 |
|---|---|---|
| Flu-Bu-Mel5-day fludarabine + 2-day busulfan (3.2mg/kg) + 2-day melphalan (50-70mg/m2) | Drug | Flu-Bu-Mel |
Primary outcome
disease-free survival (DFS)
Time frame: 1 year after transplantation
From transplantation to documentation of death or relapse or progression
6 secondary outcomes
Overall survival (OS)
Time frame: 1 year after transplantation
Relapse rate
Time frame: 1 year after transplantation
non-relapse mortality (NRM)
Time frame: 1 year after transplantation
acute graft versus host disease (aGVHD)
Time frame: day 180 after transplantation
chronic graft versus host disease (cGVHD)
Time frame: 1 year after transplantation
relapse free survival (GRFS)
Time frame: 1 year after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: No
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.
Jion HU principal investigator
Head BMT program, Rui Jin Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flu-Bu-Mel in people with Relapse Rate After Allo-HSCT, run by Shanghai Jiao Tong University School of Medicine at 2 sites in 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 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: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
disease-free survival (DFS) (time frame: 1 year after transplantation). 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 25 Oct 2023.