Acute Myeloid Leukemia, AdultPhase 3NCT02985372
Decitabine in Combination With Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia
A Phase 3 study testing Decitabine and Cytarabine in people with Acute Myeloid Leukemia, Adult, run by Chunyan Ji.
Trial summary
This prospective multicenter clinical study was designed to assess the efficacy and safety of decitabine in combination with low-dose cytarabine induction treatment for elderly patients with newly diagnosed acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia, Adult
- What is being tested?
- Decitabine and Cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with previously untreated non-M3 AML (diagnosed by the WHO2016 criteria).
- Age: ≥ 60 and ≤ 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5x upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine < 2ULN.
- Without central nervous system symptoms.
- Willing to accept the follow-up.
- Normal heart function(EF>50%). The subjects volunteer to sign the informed consent.
Who cannot join
- With severe cardiac, renal or hepatic insufficiency.
- With other cancers requiring treatment.
- With other hematological diseases(e.g. Hemophilia, myelofibrosis, etc.).
- With severe infection or metabolic disease(including tuberculosis and pulmonary aspergillosis).
- Brain disorders or severe mental diseases which could limit compliance with study requirements.
- Major operation within 3 weeks.
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- With HIV infection or AIDS-associated diseases.
- Any drug abuse, medical, mental or social situations which would affect the results.
- Hypersensitivity to cytarabine (not including drug fever or exanthema) or decitabine.
About this study
Official title: Efficacy and Safety of Decitabine in Combination With Low-dose Cytarabine as Inductive Treatment in Newly Diagnosed Elderly Patients With Acute Myeloid Leukemia
This prospective multicenter clinical study was designed to assess the efficacy and safety of decitabine in combination with low-dose cytarabine induction treatment for elderly patients with newly diagnosed acute myeloid leukemia (AML).
Read the detailed description
All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).
Hydroxyurea was permitted as rescue medication if white blood count (WBC) was >20×109/L and but was discontinued at least 24h before decitabine treatment.
Supportive care including blood product transfusions, G-CSF, antiemetic medications, antiviral and antifungal medications, or empiric antibiotics may be used at the clinical discretion of the investigator.
Curative effect was evaluated after two cycles:
- <5% blast in the marrow, enter into maintenance therapy (Group A)
- ≥5% blast in the marrow, continue induction therapy two cycles, ① <5% blast in the marrow, enter into maintenance therapy (Group B); ② ≥5% blast in the marrow, dropped out of the study (Group C)
- marrow blast decline <60%, dropped out of the study (Group C).
Maintenance therapy regimen:
- Ara-C 1g/m2/d iv drip d1-4 1 cycle
- DEC 15mg/m2/d iv drip d1-5 1 cycle
- Ara-C 1g/m2/d iv drip d1-4 1 cycle
- DEC 15mg/m2/d iv drip d1-5 1 cycle
- Conditions
- Acute Myeloid Leukemia, Adult
- Being tested
- Decitabine, 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.
DecitabineDrug
All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).
CytarabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Acute myeloid leukemia | Experimental | All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13). Receives: Drug: Decitabine; Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: three years
complete remission rate
Measured: three years
Secondary outcomes (4)
Overall survival
Measured: three years
progression-free survival
Measured: three years
mortality rate
Measured: three years
recurrence rate
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 posted7 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (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, AdultStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chunyan Ji
- Sponsor type
- University, hospital or other
- Collaborators
- Binzhou Medical University, Shengli Oilfield Hospital, Heze Municipal Hospital, Jinan Military Genaral Hospital, Jinan Central Hospital, Jining Medical University, Linyi People's Hospital, Qingdao University, Rizhao People's Hospital, Qianfoshan Hospital, Qilu Hospital of Shandong University (Qingdao), Taian City Central Hospital, Taishan Medical University Affiliated Hospital, Weihai Municipal Hospital, Weifang Medical University, Zibo First Hospital, Central Hospital of Zibo
- Responsible party
- Sponsor-investigator, Chunyan Ji, Shandong University
- Investigators
- Chunyan Ji, Doctor, Study chair, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985372
- Sponsor's protocol ID
- ESDCLDC in NDEAML
- Status last verified
- Nov 2016
- First submitted
- 25 Nov 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Decitabine in Combination With Low-dose Cytarabine as Inductive Treatment in Newly Diagnosed Elderly Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02985372
- Acronym / sponsor ID
- ESDCLDC in NDEAML
- Conditions
- Acute Myeloid Leukemia, Adult
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chunyan JiUniversity, hospital or other
- Collaborators
- Binzhou Medical University, Shengli Oilfield Hospital, Heze Municipal Hospital, Jinan Military Genaral Hospital, Jinan Central Hospital, Jining Medical University, Linyi People's Hospital, Qingdao University, Rizhao People's Hospital, Qianfoshan Hospital, Qilu Hospital of Shandong University (Qingdao), Taian City Central Hospital, Taishan Medical University Affiliated Hospital, Weihai Municipal Hospital, Weifang Medical University, Zibo First Hospital, Central Hospital of Zibo
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Dec 2016 (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 prospective multicenter clinical study was designed to assess the efficacy and safety of decitabine in combination with low-dose cytarabine induction treatment for elderly patients with newly diagnosed acute myeloid leukemia (AML).
Detailed description
All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).
Hydroxyurea was permitted as rescue medication if white blood count (WBC) was >20×109/L and but was discontinued at least 24h before decitabine treatment.
Supportive care including blood product transfusions, G-CSF, antiemetic medications, antiviral and antifungal medications, or empiric antibiotics may be used at the clinical discretion of the investigator.
Curative effect was evaluated after two cycles:
- <5% blast in the marrow, enter into maintenance therapy (Group A)
- ≥5% blast in the marrow, continue induction therapy two cycles, ① <5% blast in the marrow, enter into maintenance therapy (Group B); ② ≥5% blast in the marrow, dropped out of the study (Group C)
- marrow blast decline <60%, dropped out of the study (Group C).
Maintenance therapy regimen:
- Ara-C 1g/m2/d iv drip d1-4 1 cycle
- DEC 15mg/m2/d iv drip d1-5 1 cycle
- Ara-C 1g/m2/d iv drip d1-4 1 cycle
- DEC 15mg/m2/d iv drip d1-5 1 cycle
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute myeloid leukemia | Experimental | Drug: Decitabine, Drug: CytarabineAll patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13). |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with previously untreated non-M3 AML (diagnosed by the WHO2016 criteria).
- Age: ≥ 60 and ≤ 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5x upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine < 2ULN.
- Without central nervous system symptoms.
Key exclusion criteria (9 listed)
- With severe cardiac, renal or hepatic insufficiency.
- With other cancers requiring treatment.
- With other hematological diseases(e.g. Hemophilia, myelofibrosis, etc.).
- With severe infection or metabolic disease(including tuberculosis and pulmonary aspergillosis).
- Brain disorders or severe mental diseases which could limit compliance with study requirements.
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 |
|---|---|---|
| DecitabineAll patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13). | Drug | Acute myeloid leukemia |
| Cytarabine | Drug | Acute myeloid leukemia |
Primary outcome
Overall response rate
Time frame: three years
complete remission rate
Time frame: three years
4 secondary outcomes
Overall survival
Time frame: three years
progression-free survival
Time frame: three years
mortality rate
Time frame: three years
recurrence rate
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 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.
Chunyan Ji, Doctor study chair
Shandong University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Decitabine and Cytarabine in people with Acute Myeloid Leukemia, Adult, run by Chunyan Ji.
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 9 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 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: three years). 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 7 Dec 2016.