Acute Myeloid Leukemia in RemissionPhase 3NCT04490707
Study of Azacytidine Combined With Lenalidomide As Maintenance Therapy Based on MRD Monitoring in AML
A Phase 3 study testing Azacitidine and Lenalidomide in people with Acute Myeloid Leukemia in Remission, run by Ge Zheng at 1 site in China.
Trial summary
Great progress has been witnessed on the treatment of acute myeloid leukemia (AML) in recent years. However, elderly patients ineligible for receiving high dose chemotherapy and allo-HSCT, have high relapse rate and treatment-related complications. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Acute Myeloid Leukemia in Remission
- What is being tested?
- Azacitidine and Lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 30 Dec 2022
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with acute myeloid leukemia.Meet the criteria of the 2016 WHO classification system(APL were excluded), based on morphology, immunology, cytogenetics and molecular biology (MICM) diagnosis.
- Complete remission was evaluated according to 2020 NCCN guidelines after induction treatment.
- Patients with age≥ 60 years; or age<60 years unfit for intensive chemotherapy.
- Volunteered to sign the informed consent.
Who cannot join
- Mental disorders or other conditions that cannot meet the requirements of research, treatment and monitoring.
- Allergic to Azacytidine, Lenalidomide , or other drugs of this study
- Age over 80 years.
- Any other conditions considered by the study investigators that are not suitable for participating in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hematology, Zhongda Hospital Southeast University, Institute of Hematology Southeast University
Nanjing, Jiangsu, 210009
Zheng Ge, M.D, Ph.D, 02583262468, Janege879@hotmail.com
About this study
Official title: Clinical Study of Azacytidine Combined With Lenalidomide As Maintenance Therapy Based on MRD Monitoring In Elderly or Unfit Patients With Acute Myeloid Leukemia
Great progress has been witnessed on the treatment of acute myeloid leukemia (AML) in recent years. However, elderly patients ineligible for receiving high dose chemotherapy and allo-HSCT, have high relapse rate and treatment-related complications. Azacitidine (AZA), a listed hypomethylating agent in China in 2018, is the only approved demethylating drug in the treatment of AML, following the NCCN guidelines. In addition, lenalidomide(LEN) has been shown to rapidly enhance cytotoxic T- and natural killer (NK)-cell function and reduce relapse post-chemotherapy in patients with MM, also has substantial activity as a single agent in elderly patients with AML. Measurable residual disease (MRD) has been proven to be highly prognostic in quite a number clinical studies. This study is aimed to validate the efficacy and safety advantages of the maintenance therapy that contain AZA and LEN in elderly or unfit for intensive therapy patients with AML based on MRD monitoring.
Read the detailed description
In this study, elderly or unfit for intensive therapy AML patients who had achieved complete remission(CR) after remission-induction and consolidation chemotherapy were assigned to 3 Arms: (1) Maintenance therapy with AZA combined with LEN（AZA+LEN）: AZA 50mg/m² per day for days 1-5 and LEN 10mg per day orally for days 6-26 , every 28 days for up to 12 cycles or progression; (2) Maintenance therapy with AZA only: AZA 50mg/m² per day for days 1-5, every 28 days for up to 12 cycles or progression; (3) Observation or with supporting therapy. MRD will be assessed by flow cytometry and molecular techniques. The efficacy and safety of the 3 Arms will be evaluated in this study.
- Conditions
- Acute Myeloid Leukemia in Remission
- Being tested
- Azacitidine, Lenalidomide
- Keywords
- Acute myeloid leukemia, Azacitidine, Lenalidomide, Maintenance Therapy, MRD
- 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.
AzacitidineDrug
Also called AZA
Elderly or unfit for intensive therapy patients with acute myeloid leukemia who had entered CR receive maintenance therapy contained Azacitidine
LenalidomideDrug
Also called LEN
Elderly or unfit for intensive therapy patients with acute myeloid leukemia who had entered CR receive maintenance therapy contained Lenalidomide
| Study group | Role | What they receive |
|---|---|---|
| Azacitidine plus Lenalidomide (AZA+LEN) | Experimental | Arm 1(AZA+LEN): Elderly or unfit for intensive therapy AML patients who had achieved CR after remission-induction and consolidation chemotherapy enter maintenance therapy with AZA combined with LEN: AZA 50mg/m² per day for days 1-5 and LEN 10mg per day orally for days 6-26 , every 28 days for up to 12 cycles or progression.
AZA -Azacitidine, LEN- Lenalidomide Receives: Drug: Azacitidine; Drug: Lenalidomide |
| Azacitidine(AZA) | Experimental | Arm 2 (AZA): Elderly or unfit for intensive therapy AML patients who had achieved CR after remission-induction and consolidation chemotherapy enter maintenance therapy with AZA 50mg/m² per day for days 1-5, every 28 days for up to 12 cycles or progression.
AZA -Azacitidine Receives: Drug: Azacitidine |
| Observation | No intervention | Arm 3(Observation): Elderly or unfit for intensive therapy AML patients who had achieved CR after remission-induction and consolidation chemotherapy enter observation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
DFS in months, in present of disease free survival period of all participants
Measured: From date of randomization or complete remission until the date of first documented disease progression from any cause,assessed up to 100weeks
OS
OS in months, in present of over all survival period of all participants
Measured: From date of randomization until the date of first documented death from any cause or end of this study, whichever come first,assessed up to 100weeks
Secondary outcomes (1)
Adverse events rates
Adverse events rates in percentage
Measured: From date of randomization or initial treatment until the end date of the study, assessed up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Sep 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia in RemissionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ge Zheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ge Zheng, Zhongda Hospital
- Investigators
- Zheng Ge, M.D, Ph.D, Study director, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490707
- Sponsor's protocol ID
- ZDYYGZ202005
- Status last verified
- Mar 2022
- First submitted
- 26 Jul 2020
- Last updated
- 24 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 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Azacytidine Combined With Lenalidomide As Maintenance Therapy Based on MRD Monitoring In Elderly or Unfit Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT04490707
- Acronym / sponsor ID
- ZDYYGZ202005
- Conditions
- Acute Myeloid Leukemia in Remission
- Keywords
- Acute myeloid leukemia, Azacitidine, Lenalidomide, Maintenance Therapy, MRD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ge ZhengUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 29 Jul 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.
Great progress has been witnessed on the treatment of acute myeloid leukemia (AML) in recent years. However, elderly patients ineligible for receiving high dose chemotherapy and allo-HSCT, have high relapse rate and treatment-related complications. Azacitidine (AZA), a listed hypomethylating agent in China in 2018, is the only approved demethylating drug in the treatment of AML, following the NCCN guidelines. In addition, lenalidomide(LEN) has been shown to rapidly enhance cytotoxic T- and natural killer (NK)-cell function and reduce relapse post-chemotherapy in patients with MM, also has substantial activity as a single agent in elderly patients with AML. Measurable residual disease (MRD) has been proven to be highly prognostic in quite a number clinical studies. This study is aimed to validate the efficacy and safety advantages of the maintenance therapy that contain AZA and LEN in elderly or unfit for intensive therapy patients with AML based on MRD monitoring.
Detailed description
In this study, elderly or unfit for intensive therapy AML patients who had achieved complete remission(CR) after remission-induction and consolidation chemotherapy were assigned to 3 Arms: (1) Maintenance therapy with AZA combined with LEN（AZA+LEN）: AZA 50mg/m² per day for days 1-5 and LEN 10mg per day orally for days 6-26 , every 28 days for up to 12 cycles or progression; (2) Maintenance therapy with AZA only: AZA 50mg/m² per day for days 1-5, every 28 days for up to 12 cycles or progression; (3) Observation or with supporting therapy. MRD will be assessed by flow cytometry and molecular techniques. The efficacy and safety of the 3 Arms will be evaluated in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Azacitidine plus Lenalidomide (AZA+LEN) | Experimental | Drug: Azacitidine, Drug: LenalidomideArm 1(AZA+LEN): Elderly or unfit for intensive therapy AML patients who had achieved CR after remission-induction and consolidation chemotherapy enter maintenance therapy with AZA combined with LEN: AZA 50mg/m² per day for days 1-5 and LEN 10mg per day orally for days 6-26 , every 28 days for up to 12 cycles or progression. AZA -Azacitidine, LEN- Lenalidomide |
| Azacitidine(AZA) | Experimental | Drug: AzacitidineArm 2 (AZA): Elderly or unfit for intensive therapy AML patients who had achieved CR after remission-induction and consolidation chemotherapy enter maintenance therapy with AZA 50mg/m² per day for days 1-5, every 28 days for up to 12 cycles or progression. AZA -Azacitidine |
| Observation | No intervention | –Arm 3(Observation): Elderly or unfit for intensive therapy AML patients who had achieved CR after remission-induction and consolidation chemotherapy enter observation. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with acute myeloid leukemia.Meet the criteria of the 2016 WHO classification system(APL were excluded), based on morphology, immunology, cytogenetics and molecular biology (MICM) diagnosis.
- Complete remission was evaluated according to 2020 NCCN guidelines after induction treatment.
- Patients with age≥ 60 years; or age<60 years unfit for intensive chemotherapy.
- Volunteered to sign the informed consent.
Key exclusion criteria (4 listed)
- Mental disorders or other conditions that cannot meet the requirements of research, treatment and monitoring.
- Allergic to Azacytidine, Lenalidomide , or other drugs of this study
- Age over 80 years.
- Any other conditions considered by the study investigators that are not suitable for participating in this clinical trial.
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 |
|---|---|---|
| AzacitidineAlso: AZAElderly or unfit for intensive therapy patients with acute myeloid leukemia who had entered CR receive maintenance therapy contained Azacitidine | Drug | Azacitidine plus Lenalidomide (AZA+LEN), Azacitidine(AZA) |
| LenalidomideAlso: LENElderly or unfit for intensive therapy patients with acute myeloid leukemia who had entered CR receive maintenance therapy contained Lenalidomide | Drug | Azacitidine plus Lenalidomide (AZA+LEN) |
Primary outcome
DFS
Time frame: From date of randomization or complete remission until the date of first documented disease progression from any cause,assessed up to 100weeks
DFS in months, in present of disease free survival period of all participants
OS
Time frame: From date of randomization until the date of first documented death from any cause or end of this study, whichever come first,assessed up to 100weeks
OS in months, in present of over all survival period of all participants
1 secondary outcome
Adverse events rates
Time frame: From date of randomization or initial treatment until the end date of the study, assessed up to 100 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Acute Myeloid Leukemia in Remission
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Active, not recruitingPhase 2
Testing Nivolumab to Prevent Disease From Coming Back After Treatment in Patients With Acute Myeloid Leukemia, REMAIN Trial
Acute Myeloid Leukemia
RecruitingPhase 2
Personalized NK Cell Therapy in CBT
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
Active, not recruitingPhase 2
Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Acute Myeloid Leukemia, Adult Acute Megakaryoblastic Leukemia
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.
Zheng Ge, M.D, Ph.D study director
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azacitidine and Lenalidomide in people with Acute Myeloid Leukemia in Remission, run by Ge Zheng 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 4 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 24 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Zheng Ge, M.D, Ph.D (02583262468, Janege879@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: From date of randomization or complete remission until the date of first documented disease progression from any cause,assessed up to 100weeks). The study lists 2 primary outcomes in all. 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 24 Mar 2022.