Untreated Adult Acute Myeloid LeukemiaPhase 3NCT01633099
Therapeutic Effect and Safety Study of Decitabine in Elderly Acute Myeloid Leukemia Patients
A Phase 3 study testing Decitabine in people with Untreated Adult Acute Myeloid Leukemia and Effect of Drugs, run by Jianxiang Wang.
Trial summary
The purpose of this study is to confirm the safety and the therapeutic effect of Decitabine in the treatment of elderly Acute Myeloid Leukemia (AML) patients. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Untreated Adult Acute Myeloid Leukemia, Effect of Drugs, Drug Safety
- What is being tested?
- Decitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Jul 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of acute myeloid leukemia.De novo or secondary AML.
- Age >= 60years,female and male.
- Before the enrollment，WBC < 40×10E9/L，Plt > 20×10E9/L（Hydroxyurea is permitted.）
- In 2 weeks before the enrollment，total bilirubin < 1.5×ULN，ALT < 2.5×ULN；GGT < 2.5×ULN ，Scr < 2.0×ULN or creatinine clearance rate ≥ 50 ml/min（Cockroft-Gault）.
- Before the enrollment，patients must be free from the toxicity caused by the former treatment.Received no chemotherapy in the last 4 weeks and no nitrosourea in the last 6 weeks.
- Contraception must be taken to avoid pregnancy during the study.
- ECOG 0,1, or 2, predicted lifetime longer than 12 weeks.
- Patients must sign the informed consent prior to any study related screening procedures being performed.
Who cannot join
- Acute promyelocytic leukemia.
- Chromosome and genetic abnormalities related with t（8; 21）、inv（16）、t（15; 17）.
- Central nervous system leukemia.
- Bone marrow dry tap.
- Patients received stem cell transplantation or chemotherapy containing azacitidine,cytarabine or decitabine in last one year, radiation therapy in last 14 days,lenalidomide in 30 days before included.
- Patients suffered from autoimmune hemolytic anemia or immune thrombocytopenia.
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- Patients suffered from non-leukemia related comorbidities that will cause dysfunction of organs.
- Patients suffered from unstable angina or （NYHA）3/4 Congestive heart failure.
- Patients suffered from chronic respiratory disease and needed continued oxygen.
- Other active malignancy.
- Active HBV,HCV or AIDS patients.
- Uncontrolled virus or bacterium infection.
- The investigator believe that patients who are not suitable for this trial.
- Severe mental or body disorders which will interfere the research such as uncontrolled heart,lung diseases,diabetes,etc.
- Allergic to decitabine or its accessory.
- Patients received other researches in last 30 days.
- Without contraception.
- Complications causing organ dysfunction which are not caused by AML.
About this study
Official title: The Clinical Research About the Therapeutic Effect and Safety of 10 Days Regimen With Single-agent of Decitabine for Elderly AML Patients
The purpose of this study is to confirm the safety and the therapeutic effect of Decitabine in the treatment of elderly Acute Myeloid Leukemia (AML) patients.
Read the detailed description
The outcome of the elderly AML patients is very poor. No obvious progress was achieved in this field. Decitabine is a kind of specific DNA methylation shift enzyme inhibitor. It can reverse the DNA methylation and induce the differentiation and apoptosis of the tumor cells. Recent studies about decitabine in the treatment for elderly AML patients had achieved inspiring results and indicated that low dose decitabine maybe a good choice for elderly AML patients. So in this research the investigators plan to evaluate the safety and the therapeutic effect of decitabine in the treatment of elderly AML patients.
- Being tested
- Decitabine
- Keywords
- decitabine, acute myeloid leukemia, elderly patient
- 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
Also called Dacogen
- Number of Cycles: 4 cycles.
- Dose and drug delivery(decitabine):
The 1st cycle: 20 mg/m2, (iv,>1 hour) d1-10 of each 28 day cycle. The 2nd-4th cycle:If bone marrow blast cells≥5%, the following cycle is the same as the 1st cycle.
If bone marrow blast cells<5%, the following cycle:decitabine 20 mg/m2, (iv,>1h) on d1-5 of each 28 day cycle.
If Grade 4 neutropenia（<0.5×10E9/L）come arise after 5 days' cycle of decitabine and lasts more than 14 days in last cycle,the next cycle will decrease dose to 4 days(20 mg/m2, IV ,>1h, on d1-4 of each 28 day cycle).If Grade 4 neutropenia（<0.5×10E9/L）come arise after 4 days' cycle of decitabine and lasts more than 14 days in last cycle,the next cycle will decrease dose to 3 days(20 mg/m2, IV,>1h, on d1-3 of each 28day cycle).
| Study group | Role | What they receive |
|---|---|---|
| Decitabine, CR rate,OS,EFS,RFS | Other | Therapeutic effect and safety of 10 days of decitabine. Acute myeloid leukemia,no acute promyelocytic leukemia. Receives: Drug: Decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate after induction chemotherapy with decitabine
Measured: 21 days after the induction chemotherapy
Overall survival rate
Measured: Up to 46 months after inclusion
Event free survival rate
Measured: Up to 46 months after inclusion
Relapse free survival rate
Measured: Up to 46 months after inclusion
Secondary outcomes (10)
Adverse events of decitabine for elderly AML patients
Measured: Up to 46 months
Weight of elderly AML patients
Measured: Up to 46 months
ECOG(Eastern Cooperative Oncology Group) score for elderly AML patients
Measured: Up to 46 months
Physical examination of decitabine for elderly AML patients
Measured: Up to 46 months
Blood pressure of elderly AML patients
Measured: Up to 46 months
Respiratory rate of elderly AML patients
Measured: Up to 46 months
Heart rate of elderly AML patients
Measured: Up to 46 months
Body temperature of elderly AML patients
Measured: Up to 46 months
ECG of elderly AML patients
Measured: Up to 46 months
Bone marrow condition of elderly AML patients
Measured: Up to 46 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2014 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Untreated Adult 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianxiang Wang
- Collaborators
- Xian-Janssen Pharmaceutical Ltd.
- Responsible party
- Sponsor-investigator, Jianxiang Wang, Chinese Academy of Medical Sciences
- Investigators
- Jianxiang Wang, MD, Principal investigator, Institute of Hematology, Hospital of Blood Disease, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633099
- Sponsor's protocol ID
- DACOGENAML2003
- Status last verified
- Jul 2012
- First submitted
- 24 Jun 2012
- Last updated
- 6 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Burnett AK, Milligan D, Prentice AG, Goldstone AH, McMullin MF, Hills RK, Wheatley K. A comparison of low-dose cytarabine and hydroxyurea with or without all-trans retinoic acid for acute myeloid leukemia and high-risk myelodysplastic syndrome in patients not considered fit for intensive treatment. Cancer. 2007 Mar 15;109(6):1114-24. doi: 10.1002/cncr.22496.
PubMed 17315155
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Research About the Therapeutic Effect and Safety of 10 Days Regimen With Single-agent of Decitabine for Elderly AML Patients
- ClinicalTrials.gov ID
- NCT01633099
- Acronym / sponsor ID
- DACOGENAML2003
- Keywords
- decitabine, acute myeloid leukemia, elderly patient
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Jianxiang Wang
- Collaborators
- Xian-Janssen Pharmaceutical Ltd.
- Study start
- May 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 4 Jul 2012 (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.
The purpose of this study is to confirm the safety and the therapeutic effect of Decitabine in the treatment of elderly Acute Myeloid Leukemia (AML) patients.
Detailed description
The outcome of the elderly AML patients is very poor. No obvious progress was achieved in this field. Decitabine is a kind of specific DNA methylation shift enzyme inhibitor. It can reverse the DNA methylation and induce the differentiation and apoptosis of the tumor cells. Recent studies about decitabine in the treatment for elderly AML patients had achieved inspiring results and indicated that low dose decitabine maybe a good choice for elderly AML patients. So in this research the investigators plan to evaluate the safety and the therapeutic effect of decitabine in the treatment of elderly AML patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decitabine, CR rate,OS,EFS,RFS | Other | Drug: DecitabineTherapeutic effect and safety of 10 days of decitabine. Acute myeloid leukemia,no acute promyelocytic leukemia. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of acute myeloid leukemia.De novo or secondary AML.
- Age >= 60years,female and male.
- Before the enrollment，WBC < 40×10E9/L，Plt > 20×10E9/L（Hydroxyurea is permitted.）
- In 2 weeks before the enrollment，total bilirubin < 1.5×ULN，ALT < 2.5×ULN；GGT < 2.5×ULN ，Scr < 2.0×ULN or creatinine clearance rate ≥ 50 ml/min（Cockroft-Gault）.
- Before the enrollment，patients must be free from the toxicity caused by the former treatment.Received no chemotherapy in the last 4 weeks and no nitrosourea in the last 6 weeks.
Key exclusion criteria (18 listed)
- Acute promyelocytic leukemia.
- Chromosome and genetic abnormalities related with t（8; 21）、inv（16）、t（15; 17）.
- Central nervous system leukemia.
- Bone marrow dry tap.
- Patients received stem cell transplantation or chemotherapy containing azacitidine,cytarabine or decitabine in last one year, radiation therapy in last 14 days,lenalidomide in 30 days before included.
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 |
|---|---|---|
| DecitabineAlso: Dacogen1. Number of Cycles: 4 cycles. 2. Dose and drug delivery(decitabine): The 1st cycle: 20 mg/m2, (iv,>1 hour) d1-10 of each 28 day cycle. The 2nd-4th cycle:If bone marrow blast cells≥5%, the following cycle is the same as the 1st cycle. If bone marrow blast cells<5%, the following cycle:decitabine 20 mg/m2, (iv,>1h) on d1-5 of each 28 day cycle. If Grade 4 neutropenia（<0.5×10E9/L）come arise after 5 days' cycle of decitabine and lasts more than 14 days in last cycle,the next cycle will decrease dose to 4 days(20 mg/m2, IV ,>1h, on d1-4 of each 28 day cycle).If Grade 4 neutropenia（<0.5×10E9/L）come arise after 4 days' cycle of decitabine and lasts more than 14 days in last cycle,the next cycle will decrease dose to 3 days(20 mg/m2, IV,>1h, on d1-3 of each 28day cycle). | Drug | Decitabine, CR rate,OS,EFS,RFS |
Primary outcome
Complete response rate after induction chemotherapy with decitabine
Time frame: 21 days after the induction chemotherapy
Overall survival rate
Time frame: Up to 46 months after inclusion
Event free survival rate
Time frame: Up to 46 months after inclusion
Relapse free survival rate
Time frame: Up to 46 months after inclusion
10 secondary outcomes
Adverse events of decitabine for elderly AML patients
Time frame: Up to 46 months
Weight of elderly AML patients
Time frame: Up to 46 months
ECOG(Eastern Cooperative Oncology Group) score for elderly AML patients
Time frame: Up to 46 months
Physical examination of decitabine for elderly AML patients
Time frame: Up to 46 months
Blood pressure of elderly AML patients
Time frame: Up to 46 months
Respiratory rate of elderly AML patients
Time frame: Up to 46 months
Heart rate of elderly AML patients
Time frame: Up to 46 months
Body temperature of elderly AML patients
Time frame: Up to 46 months
ECG of elderly AML patients
Time frame: Up to 46 months
Bone marrow condition of elderly AML patients
Time frame: Up to 46 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2012.
- Background: PubMed 17315155Burnett AK, Milligan D, Prentice AG, Goldstone AH, McMullin MF, Hills RK, Wheatley K. A comparison of low-dose cytarabine and hydroxyurea with or without all-trans retinoic acid for acute myeloid leukemia and high-risk myelodysplastic syndrome in patients not considered fit for intensive treatment. Cancer. 2007 Mar 15;109(6):1114-24. doi: 10.1002/cncr.22496.
- We do not have a protocol's home page. This website is our hospital's home page and introduces some information of our hospital.Link provided by the sponsor.
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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.
Jianxiang Wang, MD principal investigator
Institute of Hematology, Hospital of Blood Disease, Chinese Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Decitabine in people with Untreated Adult Acute Myeloid Leukemia and Effect of Drugs, run by Jianxiang Wang.
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 8 inclusion and 18 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 6 Jul 2012. 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?
Complete response rate after induction chemotherapy with decitabine (time frame: 21 days after the induction chemotherapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01633099, which also lists 1 linked publication.
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 6 Jul 2012.