Acute Myelogenous LeukemiaHAMNCT04024241
Medium Dose of Cytarabine and Mitoxantrone
An observational study of Acute Myelogenous Leukemia and Chemotherapy, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
By observation of the inpatients in shenzhen people's hospital,research the curative effect of the two chemotherapy schemes on AML-High dose of cytarabine and HAM. Read more about this study
- Who is it for?
- Ages 14 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myelogenous Leukemia, Chemotherapy
- What is being tested?
- Flow Cytometer, Mitoxantrone and Cytarabine
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 31 Aug 2019
- Phase
- Observational
- 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 14 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: people diagnosed as AML expect acute promyeloytic leukemia
Who may be able to join
- people diagnosed as AML
Who cannot join
- acute promyeloytic leukemia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen
Shenzhen, Guangdong, 518000
Yixuan Cao, master, 15813880801, 358521758@qq.com
About this study
Official title: The Clinical Observationg on HAM for Acute Myeloid Leukemia
By observation of the inpatients in shenzhen people's hospital,research the curative effect of the two chemotherapy schemes on AML-High dose of cytarabine and HAM.
Read the detailed description
The patients of AML in shenzhen people's hospital were randomly divided into two therapy groups.One group was treated by High dose of cytarabine ,and the other was HAM.Evaluate the two chemotherapy schemes by bone marrow suppression time and patient survival time.
- Conditions
- Acute Myelogenous Leukemia, Chemotherapy
- Being tested
- Flow Cytometer, Mitoxantrone, Cytarabine
- Keywords
- AML HAM
- 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.
Flow CytometerDevice
high dose
MitoxantroneDrug
high dose
CytarabineDrug
high dose
| Study group | Role | What they receive |
|---|---|---|
| high dose of cytarabine | high dose of cytarabine Receives: Device: Flow Cytometer; Drug: Mitoxantrone; Drug: Cytarabine | |
| HAM | medium dose of cytarabine and mitoxantrone Receives: Device: Flow Cytometer; Drug: Mitoxantrone; Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone marrow suppression time
time of agranulocytosis
Measured: one month
patient survival time
disease free survival
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Sep 2017
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024241
- Sponsor's protocol ID
- YLi
- Acronym
- HAM
- Status last verified
- Jul 2019
- First submitted
- 16 Jul 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Observationg on HAM for Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT04024241
- Acronym / sponsor ID
- HAM / YLi
- Conditions
- Acute Myelogenous Leukemia, Chemotherapy
- Keywords
- AML HAM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 18 Jul 2019 (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.
By observation of the inpatients in shenzhen people's hospital,research the curative effect of the two chemotherapy schemes on AML-High dose of cytarabine and HAM.
Detailed description
The patients of AML in shenzhen people's hospital were randomly divided into two therapy groups.One group was treated by High dose of cytarabine ,and the other was HAM.Evaluate the two chemotherapy schemes by bone marrow suppression time and patient survival time.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high dose of cytarabine | – | Device: Flow Cytometer, Drug: Mitoxantrone, Drug: Cytarabinehigh dose of cytarabine |
| HAM | – | Device: Flow Cytometer, Drug: Mitoxantrone, Drug: Cytarabinemedium dose of cytarabine and mitoxantrone |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- people diagnosed as AML expect acute promyeloytic leukemia
Key inclusion criteria (1 listed)
- people diagnosed as AML
Key exclusion criteria (1 listed)
- acute promyeloytic leukemia
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 |
|---|---|---|
| Flow Cytometerhigh dose | Device | HAM, high dose of cytarabine |
| Mitoxantronehigh dose | Drug | HAM, high dose of cytarabine |
| Cytarabinehigh dose | Drug | HAM, high dose of cytarabine |
Primary outcome
bone marrow suppression time
Time frame: one month
time of agranulocytosis
patient survival time
Time frame: three years
disease free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Acute Myelogenous Leukemia and Chemotherapy, run by Shenzhen People's Hospital 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 1 inclusion and 1 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 18 Jul 2019. 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 Yixuan Cao, master (15813880801, 358521758@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone marrow suppression time (time frame: one month). 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 18 Jul 2019.