Acute Myeloid LeukemiaNCT02432911
Treatment of Elderly Chinese Acute Myeloid Leukemia Patients Aged 65 to 75 Years Old
A study testing CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF) and low dose cytarabine in people with Acute Myeloid Leukemia, run by Jianxiang Wang at 1 site in China.
Trial summary
This study focus on the comparison of CAG regimen to the low dose cytarabine therapy in elderly AML patients who are unfit or unwilling to receive intensive chemotherapy. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF) and low dose cytarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to May 2021
- 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Acute myeloid leukemia except APL
- ECOG PS：0-3
- Unfit or unwilling to receive intensive therapy
Who cannot join
- The one who has already received induction therapy no matter what the outcome is.
- Active cancer patients who are needed to receive treatment;
- Serious uncontrolled infectious diseases(eg.tuberculosis or invasive pulmonary aspergillosis）；
- Active heart disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Treatment and Diagnosis Center of Leukemia
Tianjin, Tianjin Municipality, 300020
Jianxiang Wang, MD, +862223909120, wangjx@medmail.com.cn
Chunlin Zhou, MD, +8613820429085, zcl7317@sina.com
About this study
Official title: A Multicenter，Open-label，Randomized Study on the Treatment of Elderly Chinese Acute Myeloid Leukemia Patients Aged 65 to 75 Years Old
This study focus on the comparison of CAG regimen to the low dose cytarabine therapy in elderly AML patients who are unfit or unwilling to receive intensive chemotherapy.
Read the detailed description
Low dose cytarabine remains to be the choice of standard for elderly AML patients who are unfit or unwilling to receive intensive treatment. CAG regimen, which is a combination of aclacinomycin，low dose cytarabine±G-CSF is used often in elderly AML patients in China. It is proved effective and safety in some pilot studies，while there is no prospective，randomized study yet.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF), low dose cytarabine
- 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.
CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF)Drug
Aclacinomycin 20mg/d for 4 days combined with cytarabine 20mg bid for 10 days with/without G-CSF 6ug/m2 from 1 day before therapy to day 10 of therapy.
low dose cytarabineDrug
Also called cytarabine
cytarabine 20mg bid for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| CAG regimen | Experimental | Aclacinomycin 20mg/d for 4 days combined with cytarabine 20mg bid for 10 days with/without G-CSF 6ug/m2 from 1 day before therapy to day 10 of therapy. Receives: Drug: CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF) |
| Low dose cytarabine | Active comparator | cytarabine 20mg bid for 10 days. Receives: Drug: low dose cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 3 years
Secondary outcomes (3)
complete remission rate
Measured: 4 months
relapse free survival
Measured: 3 years
treatment-related mortality
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2018 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianxiang Wang
- Responsible party
- Sponsor-investigator, Jianxiang Wang, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432911
- Sponsor's protocol ID
- IHBDH-IIT2015003
- Status last verified
- May 2016
- First submitted
- 29 Apr 2015
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter，Open-label，Randomized Study on the Treatment of Elderly Chinese Acute Myeloid Leukemia Patients Aged 65 to 75 Years Old
- ClinicalTrials.gov ID
- NCT02432911
- Acronym / sponsor ID
- IHBDH-IIT2015003
- Conditions
- Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jianxiang Wang
- Study start
- Apr 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 4 May 2015 (estimated)
- 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 focus on the comparison of CAG regimen to the low dose cytarabine therapy in elderly AML patients who are unfit or unwilling to receive intensive chemotherapy.
Detailed description
Low dose cytarabine remains to be the choice of standard for elderly AML patients who are unfit or unwilling to receive intensive treatment. CAG regimen, which is a combination of aclacinomycin，low dose cytarabine±G-CSF is used often in elderly AML patients in China. It is proved effective and safety in some pilot studies，while there is no prospective，randomized study yet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAG regimen | Experimental | Drug: CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF)Aclacinomycin 20mg/d for 4 days combined with cytarabine 20mg bid for 10 days with/without G-CSF 6ug/m2 from 1 day before therapy to day 10 of therapy. |
| Low dose cytarabine | Active comparator | Drug: low dose cytarabinecytarabine 20mg bid for 10 days. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Acute myeloid leukemia except APL
- ECOG PS：0-3
- Unfit or unwilling to receive intensive therapy
Key exclusion criteria (4 listed)
- The one who has already received induction therapy no matter what the outcome is.
- Active cancer patients who are needed to receive treatment;
- Serious uncontrolled infectious diseases(eg.tuberculosis or invasive pulmonary aspergillosis）；
- Active heart disease
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 |
|---|---|---|
| CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF)Aclacinomycin 20mg/d for 4 days combined with cytarabine 20mg bid for 10 days with/without G-CSF 6ug/m2 from 1 day before therapy to day 10 of therapy. | Drug | CAG regimen |
| low dose cytarabineAlso: cytarabinecytarabine 20mg bid for 10 days. | Drug | Low dose cytarabine |
Primary outcome
overall survival
Time frame: 3 years
3 secondary outcomes
complete remission rate
Time frame: 4 months
relapse free survival
Time frame: 3 years
treatment-related mortality
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- 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?
A study testing CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF) and low dose cytarabine in people with Acute Myeloid Leukemia, run by Jianxiang Wang 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 3 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 7 Oct 2016. 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 Jianxiang Wang, MD (+862223909120, wangjx@cams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 3 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 7 Oct 2016.