Hematologic MalignancyPhase 2NCT04809181
Azacitidine in Combination With Venetoclax Treatment for MRD Positive Post Allo-HSCT AML/MDS Patients
A Phase 2 study testing Azacitidine in Combination With Venetoclax in people with Hematologic Malignancy and Stem Cell Transplant Complications, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
In patients with MRD-positive patients after AML/MDS allogeneic hematopoietic stem cell transplantation, azacytidine combined with venetoclax may be effective in eliminating micro residual diseases, reducing the risk of relapse, and ultimately improving long-term survival.The primary purpose of this study was to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hematologic Malignancy, Stem Cell Transplant Complications
- What is being tested?
- Azacitidine in Combination With Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2021to 19 Mar 2026
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 years old and 65 years old.
- Patients with AML or MDS diagnosed according to WHO diagnostic criteria.
- Patients who received allogeneic hematopoietic stem cell transplantation and achieved complete remission.
- MRD was positive after transplantation, MFC > 0.1% and / or fusion gene and gene mutation (WT1 > 0.6%, AML1-ETO > 0.4%, others >1%).
- ECOG body status score 0-2.
- Patients with expected survival time >=3 months.
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- Good organ function level: ANC (neutrophil absolute value >=1.0x10^9/L; PLT >=30x10^9/L; HB >=80g/L; Tibil <=1.5 ULN; ALT / AST <=2.5 ULN; bun / Cr <=1.5 ULN; LVEF >=50%).
- Patients who have received any anti-tumor treatment (including radiotherapy, chemotherapy, surgery or molecular targeted treatment) for more than 4 weeks from the end of the previous treatment.
- Patients with no GVHD and no previous history of 3 or more degrees of aGVHD. 10. Patients who voluntarily participate in the clinical trial, understand the research procedure and can sign the informed consent in writing.
Who cannot join
- Patients with severe cardiac insufficiency and EF lower than 60%; or patients with severe arrhythmia who could not tolerate super pretreatment.
- Patients with activity of aGVHD or extensive cGVHD.
- Patients with BCR/ABL positive.
- Patients who were previously known to be resistant to azacytidine or dessicabine or venetoclax.
- In patients with severe pulmonary insufficiency (obstructive and / or restrictive ventilation disorders), the researchers evaluated the patients who could not tolerate the super pretreatment scheme.
- Patients with severe liver function impairment and liver function indexes (alt, TBIL) more than 3 ULN were evaluated as intolerant of super pretreatment.
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- In patients with severe renal insufficiency, the renal function index (CR) is more than 2 times of the upper limit of the normal value (ULN), or the 24-hour creatinine clearance rate (CR) is less than 50ml / min, the researchers evaluated that they could not tolerate the super pretreatment scheme.
- In patients with severe active infection, the researchers evaluated that they could not tolerate the pretreatment.
- Patients who had allergic reactions or serious adverse reactions in the previous use of pretreatment related drugs could not be included in the study.
- Patients with hematological recurrence (bone marrow smear: proportion of primordial cells >=5%) or any extramedullary recurrence.
- Other reasons why the researchers could not be selected.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Yi Luo, M.D., +86057187233801
About this study
Official title: Azacitidine in Combination With Venetoclax Treatment for Prevention of Relapse in MRD Positive Post Allogeneic Hematopoietic Stem Cell Transplantation Acute Myelogenous Leukemia/ Myelodysplastic Syndrome Patients
In patients with MRD-positive patients after AML/MDS allogeneic hematopoietic stem cell transplantation, azacytidine combined with venetoclax may be effective in eliminating micro residual diseases, reducing the risk of relapse, and ultimately improving long-term survival.The primary purpose of this study was to explore an effective protocol to reduce the risk of relapse in patients with MRD positive after allogeneic hematopoietic stem cell transplantation for AML/MDS.
Read the detailed description
The technology of Allogeneic Hematopoietic stem cell transplantation (allo-HSCT) has been continuously improved, relpase is still the leading cause of death after allo-HSCT. Monitoring of micro residual disease (MRD) after allogeneic HSCT provides a risk stratification of relpase risk in patients after transplantation.There is an urgent need to find an effective intervention plan for patients with MRD positive after transplantation, in order to reduce the risk of relapse after transplantation and improve long-term survival.The combination of demethylated drugs with venetoclax has shown promising results in clinical trials in AML patients who cannot tolerate induction chemotherapy.In patients with MRD-positive patients after AML/MDS allo-HSCT, azacytidine combined with venetoclax may be effective in eliminating small residual diseases, reducing the risk of relapse, and ultimately improving long-term survival.The primary purpose of this study was to explore an effective protocol to reduce the risk of relapse in patients with MRD positive after allo-HSCT for AML/MDS.
- Being tested
- Azacitidine in Combination With Venetoclax
- Keywords
- Allogeneic Hematopoietic stem cell transplantation, Micro residual disease, Azacitidine, Venetoclax, Relapse
- Medical subject headings
- Hematologic Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azacitidine in Combination With VenetoclaxDrug
Azacitidine in combination with venetoclax
| Study group | Role | What they receive |
|---|---|---|
| MRD positive AML/MDS patients after allogeneic hematopoietic stem cell transplantation | Experimental | MRD positive AML/MDS patients after allogeneic hematopoietic stem cell transplantation Receives: Drug: Azacitidine in Combination With Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse-free survival
relapse-free survival
Measured: 2 year
Secondary outcomes (4)
overall survival
overall survival
Measured: 2 year
graft-versus-host disease -free relapse-free survival
graft-versus-host disease -free relapse-free survival
Measured: 2 year
cumulative incidence of aGVHD
cumulative incidence of aGVHD
Measured: 100 days
cumulative incidence of cGVHD
cumulative incidence of cGVHD
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 posted22 Mar 2021
- Study start19 Mar 2021
- Primary completion19 Mar 2024 (estimated)
- Study completion19 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Zhejiang Provincial People's Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, Sir Run Run Shaw Hospital, First Affiliated Hospital of Wenzhou Medical University, Ningbo No. 1 Hospital, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Jinhua Central Hospital, Taizhou Hospital, Union hospital of Fujian Medical University, Xiangya Hospital of Central South University
- Responsible party
- Principal investigator, Yi Luo, First Affiliated Hospital of Zhejiang University
- Investigators
- Yi Luo, M.D., Principal investigator, First Affilaated Hospital of Medical School of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809181
- Sponsor's protocol ID
- ZJU-HSCT-AZA02
- Status last verified
- Feb 2023
- First submitted
- 19 Mar 2021
- Last updated
- 21 Feb 2023
- 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azacitidine in Combination With Venetoclax Treatment for Prevention of Relapse in MRD Positive Post Allogeneic Hematopoietic Stem Cell Transplantation Acute Myelogenous Leukemia/ Myelodysplastic Syndrome Patients
- ClinicalTrials.gov ID
- NCT04809181
- Acronym / sponsor ID
- ZJU-HSCT-AZA02
- Keywords
- Allogeneic Hematopoietic stem cell transplantation, Micro residual disease, Azacitidine, Venetoclax, Relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Zhejiang Provincial People's Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, Sir Run Run Shaw Hospital, First Affiliated Hospital of Wenzhou Medical University, Ningbo No. 1 Hospital, Yinzhou Hospital Affiliated to Medical School of Ningbo University, Jinhua Central Hospital, Taizhou Hospital, Union hospital of Fujian Medical University, Xiangya Hospital of Central South University
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 19 Mar 2024 (estimated)
- Study completion
- 19 Mar 2026 (estimated)
- First posted
- 22 Mar 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 patients with MRD-positive patients after AML/MDS allogeneic hematopoietic stem cell transplantation, azacytidine combined with venetoclax may be effective in eliminating micro residual diseases, reducing the risk of relapse, and ultimately improving long-term survival.The primary purpose of this study was to explore an effective protocol to reduce the risk of relapse in patients with MRD positive after allogeneic hematopoietic stem cell transplantation for AML/MDS.
Detailed description
The technology of Allogeneic Hematopoietic stem cell transplantation (allo-HSCT) has been continuously improved, relpase is still the leading cause of death after allo-HSCT. Monitoring of micro residual disease (MRD) after allogeneic HSCT provides a risk stratification of relpase risk in patients after transplantation.There is an urgent need to find an effective intervention plan for patients with MRD positive after transplantation, in order to reduce the risk of relapse after transplantation and improve long-term survival.The combination of demethylated drugs with venetoclax has shown promising results in clinical trials in AML patients who cannot tolerate induction chemotherapy.In patients with MRD-positive patients after AML/MDS allo-HSCT, azacytidine combined with venetoclax may be effective in eliminating small residual diseases, reducing the risk of relapse, and ultimately improving long-term survival.The primary purpose of this study was to explore an effective protocol to reduce the risk of relapse in patients with MRD positive after allo-HSCT for AML/MDS.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRD positive AML/MDS patients after allogeneic hematopoietic stem cell transplantation | Experimental | Drug: Azacitidine in Combination With VenetoclaxMRD positive AML/MDS patients after allogeneic hematopoietic stem cell transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients between 18 years old and 65 years old.
- Patients with AML or MDS diagnosed according to WHO diagnostic criteria.
- Patients who received allogeneic hematopoietic stem cell transplantation and achieved complete remission.
- MRD was positive after transplantation, MFC > 0.1% and / or fusion gene and gene mutation (WT1 > 0.6%, AML1-ETO > 0.4%, others >1%).
- ECOG body status score 0-2.
Key exclusion criteria (11 listed)
- Patients with severe cardiac insufficiency and EF lower than 60%; or patients with severe arrhythmia who could not tolerate super pretreatment.
- Patients with activity of aGVHD or extensive cGVHD.
- Patients with BCR/ABL positive.
- Patients who were previously known to be resistant to azacytidine or dessicabine or venetoclax.
- In patients with severe pulmonary insufficiency (obstructive and / or restrictive ventilation disorders), the researchers evaluated the patients who could not tolerate the super pretreatment scheme.
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 |
|---|---|---|
| Azacitidine in Combination With VenetoclaxAzacitidine in combination with venetoclax | Drug | MRD positive AML/MDS patients after allogeneic hematopoietic stem cell transplantation |
Primary outcome
relapse-free survival
Time frame: 2 year
relapse-free survival
4 secondary outcomes
overall survival
Time frame: 2 year
graft-versus-host disease -free relapse-free survival
Time frame: 2 year
cumulative incidence of aGVHD
Time frame: 100 days
cumulative incidence of cGVHD
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 21 Feb 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.
Yi Luo, M.D. principal investigator
First Affilaated Hospital of Medical School of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azacitidine in Combination With Venetoclax in people with Hematologic Malignancy and Stem Cell Transplant Complications, run by First Affiliated Hospital of Zhejiang University 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 9 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 21 Feb 2023. 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.
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 Yi Luo, M.D. (+86057187233801, luoyijr@163.com), 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: 2 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 21 Feb 2023.