Adult Acute Myeloid LeukemiaNCT05262465
Microtransplantation Combined With Azacytidine to Improve the Efficacy of EAML
A study testing microtransplantation, HLA-mismatched donor peripheral stem cell infusion, Azacitidine and Venetoclax in people with Adult Acute Myeloid Leukemia, run by guomei at 1 site in China.
Trial summary
Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are recieved induction and consolidation chemotherapy with microtransplantation . Observe the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Adult Acute Myeloid Leukemia
- What is being tested?
- microtransplantation, HLA-mismatched donor peripheral stem cell infusion, Azacitidine and Venetoclax
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 1 Jul 2025
- Phase
- Interventional
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have elderly (60-85 ages) AML pathologically confirmed per WHO guidelines.
- Patients have not been treated before.
- Patients must have ECOG Performance status of 0,1,or 2. If ECOG 2.
- Patients must have a HLA mismatched donor who should be able to provide informed consent.
- All genders and races are eligible.
- ALT and AST≤3 ×ULN, TBIL≤1.5 × ULN, Cr≤2 ×ULN or CrCl≥40 mL/min
- By means of ultrasonic Heartbeat map or multiple gated acquisition (MUGA) scanning determination of LVEF in the normal range.
- Donors must be able to safely undergo leukapheresis.
Who cannot join
- received operation 4 weeks before randomization
- acute promyelocytic leukemia,Myeloid sarcoma, chronic myeloid leukemia in accelerated phase and blastic phase;
- active CNS disease, pregnancy, or other major medical or psychiatric illnesses that could compromise tolerance to this protocol
- occurred stroke or intracranial hemorrhage within 6 months before randomization.
- Require the use of warfarin or equivalent of vitamin K antagonists (such as phenprocoumon) anticoagulant.
- There is clinical significance of cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months before randomization, or any heart function grade 3 (moderate) or 4 (severe ) heart disease in accordance with the functional classification method of New York Heart Association (NYHA).
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- Known to have the following history: human immunodeficiency virus (HIV) or active hepatitis C virus or hepatitis B virus infection
- Any situation processed by the PI that will be damaged to the patients safety.
- Patients and / or authorized family member refuse to sign the consent.
- attend other clinical researchers in 3 months.
- Donors exclusion criteria include:active infection or malignancy, cardiovascular instability, severe anemia, severe coagulation disorder, pregnancy, inadequate venous access, inability to provide consent, or any other condition deemed unsafe by the treatment staff.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The fifth medical center of PLA General Hospital
Beijing, Beijing Municipality
mei guo, +8615811031508, 15811031508@163.com
yajing huang, +8615811031508, yajing_huang@163.com
About this study
Official title: A Multicenter Clinical Study of Microtransplantation Combined With Azacytidine to Improve the Efficacy of Elderly Acute Myeloid Leukemia
Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are recieved induction and consolidation chemotherapy with microtransplantation . Observe the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate.
Read the detailed description
Microtransplantation, which combines chemotherapy with adoptive infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC). Data from more than 70 elderly AML patients who received microtransplantation in Beijing showed that the remission rate and 2-year disease-free survival (DFS) reach 75-82% and 32-39% respectively, and microchimerisms (donor cells<1%) were detected without GVHD. The results have been clinically validated in several other centers in China, United States and Australia.
In this study, azacytidine, decitabine, BCL / 2 inhibitor and other drugs combined with micro transplantation were used in elderly AML in order to improve the curative effect.
Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are recieved induction and consolidation chemotherapy with microtransplantation . Observe the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate.
- Conditions
- Adult Acute Myeloid Leukemia
- Being tested
- microtransplantation, HLA-mismatched donor peripheral stem cell infusion, Azacitidine, Venetoclax
- 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.
microtransplantation, HLA-mismatched donor peripheral stem cell infusionBiological
Also called DSI
HLA-mismatched donor peripheral stem cell infusion
AzacitidineDrug
Also called Demethylated drugs
azacytidine 50-75mg/m2
VenetoclaxDrug
Also called BCL/2 inhibitor
Venetoclax 100-300mg/d ×3d，400mg 4-28d
| Study group | Role | What they receive |
|---|---|---|
| MST for unfit | Experimental | Induction chemotherapy can use azacytidine combined with low-dose cytarabine, or azacytidine combined with BCL / 2 inhibitor, and infuse modified peripheral blood hematopoietic stem cells after chemotherapy.
Consolidation chemotherapy used azacytidine combined with low-dose cytarabine. After chemotherapy, modified peripheral blood hematopoietic stem cells were infused and repeated for 3 courses. Receives: Biological: microtransplantation, HLA-mismatched donor peripheral stem cell infusion; Drug: Azacitidine; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
the remission rate
①bone marrow: blasts <5% (with a count of at least 200 Nucleated cells).②Hemogram: absolute neutrophil count of more than 1.0×109/L，platelets of >100×109/L. ③Clinical: Without the signs and symptoms caused by leukemia infiltration d , and independent of transfusion;
Measured: 2month
Secondary outcomes (2)
Disease Free Survival
Measured from complete remission to the date of death or the date of last follow-up examination;
Measured: 2 year
Overall Survival
measured from the Date of beginning therapy to the date of death or the date of last follow-up examination;
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Jul 2020
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Acute Myeloid LeukemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- guomei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, guomei, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262465
- Sponsor's protocol ID
- MST-EAML2020
- Status last verified
- Feb 2022
- First submitted
- 21 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study of Microtransplantation Combined With Azacytidine to Improve the Efficacy of Elderly Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05262465
- Acronym / sponsor ID
- MST-EAML2020
- Conditions
- Adult Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- guomeiUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 2 Mar 2022 (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.
Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are recieved induction and consolidation chemotherapy with microtransplantation . Observe the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate.
Detailed description
Microtransplantation, which combines chemotherapy with adoptive infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC). Data from more than 70 elderly AML patients who received microtransplantation in Beijing showed that the remission rate and 2-year disease-free survival (DFS) reach 75-82% and 32-39% respectively, and microchimerisms (donor cells<1%) were detected without GVHD. The results have been clinically validated in several other centers in China, United States and Australia.
In this study, azacytidine, decitabine, BCL / 2 inhibitor and other drugs combined with micro transplantation were used in elderly AML in order to improve the curative effect.
Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are recieved induction and consolidation chemotherapy with microtransplantation . Observe the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MST for unfit | Experimental | Biological: microtransplantation, HLA-mismatched donor peripheral stem cell infusion, Drug: Azacitidine, Drug: VenetoclaxInduction chemotherapy can use azacytidine combined with low-dose cytarabine, or azacytidine combined with BCL / 2 inhibitor, and infuse modified peripheral blood hematopoietic stem cells after chemotherapy. Consolidation chemotherapy used azacytidine combined with low-dose cytarabine. After chemotherapy, modified peripheral blood hematopoietic stem cells were infused and repeated for 3 courses. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have elderly (60-85 ages) AML pathologically confirmed per WHO guidelines.
- Patients have not been treated before.
- Patients must have ECOG Performance status of 0,1,or 2. If ECOG 2.
- Patients must have a HLA mismatched donor who should be able to provide informed consent.
- All genders and races are eligible.
Key exclusion criteria (11 listed)
- received operation 4 weeks before randomization
- acute promyelocytic leukemia,Myeloid sarcoma, chronic myeloid leukemia in accelerated phase and blastic phase;
- active CNS disease, pregnancy, or other major medical or psychiatric illnesses that could compromise tolerance to this protocol
- occurred stroke or intracranial hemorrhage within 6 months before randomization.
- Require the use of warfarin or equivalent of vitamin K antagonists (such as phenprocoumon) anticoagulant.
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 |
|---|---|---|
| microtransplantation, HLA-mismatched donor peripheral stem cell infusionAlso: DSIHLA-mismatched donor peripheral stem cell infusion | Biological | MST for unfit |
| AzacitidineAlso: Demethylated drugsazacytidine 50-75mg/m2 | Drug | MST for unfit |
| VenetoclaxAlso: BCL/2 inhibitorVenetoclax 100-300mg/d ×3d，400mg 4-28d | Drug | MST for unfit |
Primary outcome
the remission rate
Time frame: 2month
①bone marrow: blasts <5% (with a count of at least 200 Nucleated cells).②Hemogram: absolute neutrophil count of more than 1.0×109/L，platelets of >100×109/L. ③Clinical: Without the signs and symptoms caused by leukemia infiltration d , and independent of transfusion;
2 secondary outcomes
Disease Free Survival
Time frame: 2 year
Overall Survival
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microtransplantation, HLA-mismatched donor peripheral stem cell infusion, Azacitidine and Venetoclax in people with Adult Acute Myeloid Leukemia, run by guomei at 1 site 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 8 inclusion and 11 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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 yajing huang (+8615811031508, yajing_huang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the remission rate (time frame: 2month). 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 2 Mar 2022.