Refractory Acute Myeloid LeukemiaPhase 2NCT04904237
Aza-Ven Followed by Reduced Toxicity Conditioning Regimen (MBF) as Salvage Therapy for Refractory AML.
A Phase 2 study testing Aza-Ven-allo-HSCT in people with Refractory Acute Myeloid Leukemia, run by Shanghai Jiao Tong University School of Medicine at 3 sites in China.
Trial summary
In this phase clinical trail, we evaluate the efficacy and feasibility of azacytidine and venetoclax as leukemia debulking treatment followed by reduced intensity conditioning regimen consisting of Fludarabine + Busulfan + Melphalan as salvage treatment in patients with refractory AML . Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Refractory Acute Myeloid Leukemia
- What is being tested?
- Aza-Ven-allo-HSCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2021to 1 Jun 2024
- 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
- refractory AML (no remission after 2 induction therapy, relapsed AML within 6 months of first complete remission (CR), relapse AML no CR after reinduction therapy), multiple relapse and refractory relapse AML
- patients with HLA matched related or unrelated donor (9~10/10) or haplo-identical related donor
Who cannot join
- Patients with poor liver function (enzyme >2N or bilirubin >2N)
- poor renal function (Scr >1.5N)
- poor cardiac function （EF<45%）
- inform consent not provided
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, 200025
Jiong HU, M.D., 86-21-64370045 ext. 601818, hj10709@rjh.com.cn
- Recruiting
Department of Hematology, Shanghai No6 Hospital
Shanghai
Chunkang Chang, 86-21-64369181, changchunkang@sjtu.edu.cn
- Recruiting
Shanghai ZhaXin Hospital
Shanghai
Chun Wang, 13386259777, wangchun2@medmail.com.cn
About this study
Official title: Azacytidine-venetoclax Combination as Leukemia Debulking Treatment Followed by Reduced Toxicity Conditioning Regimen (Melphalan Busulfan and Fludarabine, MBF) as Salvage Therapy for Refractory Acute Myeloid Leukemia (AML).
In this phase clinical trail, we evaluate the efficacy and feasibility of azacytidine and venetoclax as leukemia debulking treatment followed by reduced intensity conditioning regimen consisting of Fludarabine + Busulfan + Melphalan as salvage treatment in patients with refractory AML .
Read the detailed description
In refractory AML, allogeneic hematopoietic stem cell transplantation (allo-HCST) is considered as the only curative regimen. In this phase II clinical trial, we plan to evaluate the efficacy and feasibility of new sequential transplantation protocol. All patients receive azacytidine and venetoclax as leukemia debulking treatment which is followed by reduced intensity conditioning regimen consisting of Fludarabine (150mg/m2) + Busulfan (6.4mg/kg) + Melphalan (70mg/m2). The graft-versus host disease (GVHD) prophylaxis regimen is based on reduced dose of post-transplantation cyclophosphamide (PT-CY) 40mg/kg day+3~+4, tacrolimus and low-dose anti-thymoglobulin (ATG, 2.5mg/kg) in case of HLA-matched unrelated donor or halo-donor transplantation.
- Conditions
- Refractory Acute Myeloid Leukemia
- Being tested
- Aza-Ven-allo-HSCT
- Keywords
- refractory, acute myeloid leukemia, hematopoietic stem cell transplantation
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aza-Ven-allo-HSCTDrug
Also called Aza-Ven MBF
aaa-ven treatment followed by allo-HCTS with reduced toxicity conditioning (RTC) of Fludarabine, Busulifan and Melphalan
| Study group | Role | What they receive |
|---|---|---|
| aza-ven +MBF | Experimental | treatment with aza-ven debulking therapy followed by allo-HSCT with MBF conditioning Receives: Drug: Aza-Ven-allo-HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse-free survival
event defined as relapse or death of any causes
Measured: 12 months
Secondary outcomes (4)
overall survival
event defined as death of all causes
Measured: 12 months
non-relapse mortality
event defined as death of all causes other than leukemia relapse
Measured: 12 months
relapse
event defined as leukemia relapse
Measured: 12 months
GVHD and relapse free survival (GRFS)
event defined as leukemia relapse, death of any causes, III-IV aGVHD or moderate to severe cGVHD
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Acute Myeloid LeukemiaStudies 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
- 23 participants (estimated)
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
- Jiong HU, Principal investigator, Shanghai Rui Jin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904237
- Sponsor's protocol ID
- RJH-rAML-2021
- Status last verified
- May 2021
- First submitted
- 22 May 2021
- Last updated
- 1 Jun 2021
- 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 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azacytidine-venetoclax Combination as Leukemia Debulking Treatment Followed by Reduced Toxicity Conditioning Regimen (Melphalan Busulfan and Fludarabine, MBF) as Salvage Therapy for Refractory Acute Myeloid Leukemia (AML).
- ClinicalTrials.gov ID
- NCT04904237
- Acronym / sponsor ID
- RJH-rAML-2021
- Conditions
- Refractory Acute Myeloid Leukemia
- Keywords
- refractory, acute myeloid leukemia, hematopoietic stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 27 May 2021 (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.
In this phase clinical trail, we evaluate the efficacy and feasibility of azacytidine and venetoclax as leukemia debulking treatment followed by reduced intensity conditioning regimen consisting of Fludarabine + Busulfan + Melphalan as salvage treatment in patients with refractory AML .
Detailed description
In refractory AML, allogeneic hematopoietic stem cell transplantation (allo-HCST) is considered as the only curative regimen. In this phase II clinical trial, we plan to evaluate the efficacy and feasibility of new sequential transplantation protocol. All patients receive azacytidine and venetoclax as leukemia debulking treatment which is followed by reduced intensity conditioning regimen consisting of Fludarabine (150mg/m2) + Busulfan (6.4mg/kg) + Melphalan (70mg/m2). The graft-versus host disease (GVHD) prophylaxis regimen is based on reduced dose of post-transplantation cyclophosphamide (PT-CY) 40mg/kg day+3~+4, tacrolimus and low-dose anti-thymoglobulin (ATG, 2.5mg/kg) in case of HLA-matched unrelated donor or halo-donor transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aza-ven +MBF | Experimental | Drug: Aza-Ven-allo-HSCTtreatment with aza-ven debulking therapy followed by allo-HSCT with MBF conditioning |
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)
- refractory AML (no remission after 2 induction therapy, relapsed AML within 6 months of first complete remission (CR), relapse AML no CR after reinduction therapy), multiple relapse and refractory relapse AML
- patients with HLA matched related or unrelated donor (9~10/10) or haplo-identical related donor
Key exclusion criteria (4 listed)
- Patients with poor liver function (enzyme >2N or bilirubin >2N)
- poor renal function (Scr >1.5N)
- poor cardiac function （EF<45%）
- inform consent not provided
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 |
|---|---|---|
| Aza-Ven-allo-HSCTAlso: Aza-Ven MBFaaa-ven treatment followed by allo-HCTS with reduced toxicity conditioning (RTC) of Fludarabine, Busulifan and Melphalan | Drug | aza-ven +MBF |
Primary outcome
relapse-free survival
Time frame: 12 months
event defined as relapse or death of any causes
4 secondary outcomes
overall survival
Time frame: 12 months
non-relapse mortality
Time frame: 12 months
relapse
Time frame: 12 months
GVHD and relapse free survival (GRFS)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- 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.
Jiong HU principal investigator
Shanghai Rui Jin Hospital
3 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 Aza-Ven-allo-HSCT in people with Refractory Acute Myeloid Leukemia, run by Shanghai Jiao Tong University School of Medicine at 3 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 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: status not confirmed, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiong HU (86-21-64370045 ext. 601878, hj10709@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relapse-free survival (time frame: 12 months). 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 1 Jun 2021.