AML in RemissionPhase 2/3NCT04216771
Comparing the Consolidation Regimens of IDA With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone for Elderly AML Patients
A Phase 2/3 study testing Idarubicin and ID cytarabine in people with AML in Remission, run by Fujian Medical University at 1 site in China.
Trial summary
This study evaluates Idarubicin (IDA) in combination with the intermediate-dose cytarabine, compared with intermediate-dose cytarabine alone, as a consolidation treatment for elderly AML in first remission. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- AML in Remission
- What is being tested?
- Idarubicin and ID cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Jan 2020to May 2024
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed de novo AML who achieved complete remission (CR), including CRi and CRp after a maximum number of 2 cycles of induction chemotherapy.
- Histologically or morphologically confirmed diagnosis of AML except for AML M3 (acute promyelocytic leukemia)
- No contraindication to anthracyclines : decompensated or uncontrolled heart failure, recent myocardial infarction, current signs of cardiac impairment, uncontrolled arrhythmias, LVEF (left ventricular ejection fraction) < 50%
- Age ≥ 60 years and < 75 years
- ECOG performance status ≤2
- Written informed consent
- No psychological, familial, social, or geographic reason that would compromise clinical follow up
Who cannot join
- Relapsed or refractory AML
- Patients with acute promyelocytic leukemia (APL)
- Patients with secondary type AML (post myelodysplastic syndrome MDS or therapy-related AML)
- Severe pshyciatric or organic disorder, supposed to be independent from AML, that would contraindicate treatment
- Subjects for which allogeneic HSCT is planned in CR1
- Known allergic or hypersensitivity to idarubicin or cytarabine or to any of the test compounds, materials
- Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk
- A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Jianda Hu, Prof., 86-13959169016, drjiandahu@163.com
Ting Yang, Prof., 86-13950210357, yang.hopeting@gmail.com
About this study
Official title: Randomized Comparison of Consolidation Treatment in Elderly Patients With Acute Myeloid Leukemia: Idarubicin (IDA) Combined With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone
This study evaluates Idarubicin (IDA) in combination with the intermediate-dose cytarabine, compared with intermediate-dose cytarabine alone, as a consolidation treatment for elderly AML in first remission.
- Conditions
- AML in Remission
- Being tested
- Idarubicin, ID cytarabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IdarubicinDrug
Idarubicin 10mg/m²/day, D1 (IV)
ID cytarabineDrug
Cytarabine 1.5g/m² /12h, D1-D3 (IV)
| Study group | Role | What they receive |
|---|---|---|
| IDA with ID Cytarabine | Experimental | Not described Receives: Drug: Idarubicin; Drug: ID cytarabine |
| ID Cytarabine | Active comparator | Not described Receives: Drug: ID cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse free survival
RFS
Measured: 2 years
Secondary outcomes (3)
Toxicities
Number and CTC grade of all adverse events related to study treatment analyzed in an descriptive way
Measured: enitire study course until 2 years
Minimum Residual Disease
Immunophenotypic characterization of human bone marrow cells will be done to determine MRD
Measured: 6, 9, 12,18 and 24 months
Overall survival
OS
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study startJan 2020 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML in RemissionStudies of the same condition, open and under way.
- More trials run by Fujian Medical 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianda Hu, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216771
- Sponsor's protocol ID
- AML-19-01
- Status last verified
- Jan 2020
- First submitted
- 29 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Consolidation Treatment in Elderly Patients With Acute Myeloid Leukemia: Idarubicin (IDA) Combined With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone
- ClinicalTrials.gov ID
- NCT04216771
- Acronym / sponsor ID
- AML-19-01
- Conditions
- AML in Remission
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 3 Jan 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.
This study evaluates Idarubicin (IDA) in combination with the intermediate-dose cytarabine, compared with intermediate-dose cytarabine alone, as a consolidation treatment for elderly AML in first remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDA with ID Cytarabine | Experimental | Drug: Idarubicin, Drug: ID cytarabine |
| ID Cytarabine | Active comparator | Drug: ID cytarabine |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed de novo AML who achieved complete remission (CR), including CRi and CRp after a maximum number of 2 cycles of induction chemotherapy.
- Histologically or morphologically confirmed diagnosis of AML except for AML M3 (acute promyelocytic leukemia)
- No contraindication to anthracyclines : decompensated or uncontrolled heart failure, recent myocardial infarction, current signs of cardiac impairment, uncontrolled arrhythmias, LVEF (left ventricular ejection fraction) < 50%
- Age ≥ 60 years and < 75 years
- ECOG performance status ≤2
Key exclusion criteria (8 listed)
- Relapsed or refractory AML
- Patients with acute promyelocytic leukemia (APL)
- Patients with secondary type AML (post myelodysplastic syndrome MDS or therapy-related AML)
- Severe pshyciatric or organic disorder, supposed to be independent from AML, that would contraindicate treatment
- Subjects for which allogeneic HSCT is planned in CR1
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 |
|---|---|---|
| IdarubicinIdarubicin 10mg/m²/day, D1 (IV) | Drug | IDA with ID Cytarabine |
| ID cytarabineCytarabine 1.5g/m² /12h, D1-D3 (IV) | Drug | ID Cytarabine, IDA with ID Cytarabine |
Primary outcome
Relapse free survival
Time frame: 2 years
RFS
3 secondary outcomes
Toxicities
Time frame: enitire study course until 2 years
Minimum Residual Disease
Time frame: 6, 9, 12,18 and 24 months
Overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
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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 Phase 2/3 study testing Idarubicin and ID cytarabine in people with AML in Remission, run by Fujian Medical 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 7 inclusion and 8 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 3 Jan 2020. 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 combined 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.
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 Jianda Hu, Prof.M.D.Ph.D (86-13959169016, drjiandahu@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 years). 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 3 Jan 2020.