Acute Myeloid LeukemiaPhase 2NCT00866073
Study of Low-Dose Intravenous Decitabine in Patients Aged > 60 Years With Acute Myeloid Leukemia
A Phase 2 study testing Decitabine 15 mg/m2 i.v. in people with Acute Myeloid Leukemia, run by University Hospital Freiburg at 8 sites in 2 countries.
Trial summary
This study is an open-label phase II trial to investigate the efficacy and toxicity of low-dose decitabine (5-aza-2'-deoxycytidine) in elderly patients with acute myeloid leukemia (AML) not eligible for aggressive induction chemotherapy. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Decitabine 15 mg/m2 i.v.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Apr 2003to Mar 2009
- Phase
- Phase 2
- 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
- Patients older than 60 years with acute myeloid leukemia (> 30 % bone marrow blasts) not qualifying for, or not consenting to, standard induction chemotherapy or immediate allografting
- life expectancy > 3 months with successful treatment
- performance status ECOG 0, 1, 2
- age-adjusted normal cardiac, kidney, liver function (creatinine < 1.5 mg/dl unless leukemia-related, total bilirubin < 2.0 of upper normal limits)
- patients with >50 000 leukocytes/µl in whom initial cytoreduction according to protocol is effective
- written informed consent
Who cannot join
- AML of FAB subtype M3
- previous induction-type chemotherapy for MDS or AML
- previous treatment with Decitabine, 5-azacytidine or ATRA
- "low-dose" chemotherapy (e.g.hydroxyurea, cytosine arabinoside, melphalan) within 8 weeks prior to Decitabine treatment, except for cytoreduction of leukocytosis > 50 000/µl according to protocol - patients with > 50 000 leukocytes/µl in whom initial cytoreduction according to protocol is ineffective
- treatment with cytokines within previous 4 weeks
- concomitant use of any other investigational drug
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- other malignancy that is not in remission (previous chemotherapy for other malignancies is not an exclusion criteria)
- cardiac insufficiency NYHA IV
- HIV infection
- other uncontrolled active infection
- psychiatric disorder that interferes with treatment
- known hypersensitivity to retinoids
- contact lenses
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Germany7 sites
Klinikum der Technischen Universität Aachen
Aachen
Universitätsklinikum Düsseldorf
Düsseldorf
Katholisches Krankenhaus Hagen
Hagen
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Klinikum Lüdenscheid
Lüdenscheid
Universitätsklinikum Ulm
Ulm
Klinikum Villingen-Schwenningen
Villingen-Schwenningen
About this study
Official title: Phase II Study of Low-Dose Intravenous Decitabine in Patients Aged > 60 Years With Acute Myeloid Leukemia Who Are Not Eligible for Standard Induction Chemotherapy
This study is an open-label phase II trial to investigate the efficacy and toxicity of low-dose decitabine (5-aza-2'-deoxycytidine) in elderly patients with acute myeloid leukemia (AML) not eligible for aggressive induction chemotherapy. AML patients above the age of 60 years (no upper age limit) who have not previously received and are not eligible for, standard induction treatment of their disease will be eligible for this trial. Decitabine will be administered as a 3 hour infusion at 15 mg/m2 three times daily on three consecutive days (total dose 135 mg/m2). In all patients with > 20000 WBC/µl, this treatment will be repeated 1 week later. In patients with white blood cells exceeding 50 000/μl, decitabine treatment will be preceded by cytoreductive doses of hydroxyurea.
Read the detailed description
Hypothesis: If after 4 courses of Decitabine none out of 12 patients achieves a response (complete or partial remission, antileukemic effect), the protocol will be stopped. If at least one response is seen among the first 12 patients, 17 additional patients will be treated in an open, uncontrolled manner. If in 3 or more of these 29 patients a response is achieved, this treatment will be considered effective and will be studied further, otherwise it will be considered ineffective. At a preliminary analysis after recruitment of 29 patients, encouraging results (response rate, tolerability) are prompting continuation of recruitment, with a planned inclusion of at least 60 patients, until initiation of the planned large, controlled phase II follow-up trial. Unexpected toxicities will be carefully evaluated. 29 patients were needed for the first two steps of this phase II study, at least 60 patients are planned for the extension of the recruitment. Expected study duration for the first two steps was 15-20 months, with 35-40 months total when including the third step.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Decitabine 15 mg/m2 i.v.
- Keywords
- AML, Acute myeloid leukemia, Decitabine
- 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.
Decitabine 15 mg/m2 i.v.Drug
Also called Dacogen
Decitabine at 15 mg/m2 i.v. x 3 hours, three times daily on three consecutive days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Decitabine 15 mg/m2 i.v. - single arm Receives: Drug: Decitabine 15 mg/m2 i.v. |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate (complete and partial remissions, antileukemic effect)
Measured: after four treatment courses of Decitabine, after 6 months
Secondary outcomes (3)
overall survival
Measured: after 1 year
progression-free survival time
Measured: after 1 year
toxicity of Decitabine (alone and in combination with all-trans retinoic acid)
Measured: after 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startApr 2003
- Primary completionFeb 2009
- Study completionMar 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Investigators
- Michael Lübbert, Prof Dr med, Principal investigator, University Medical Center Freiburg - Dept. of Oncology/Hematoloy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866073
- Sponsor's protocol ID
- 00331
- Status last verified
- Mar 2009
- First submitted
- 19 Mar 2009
- Last updated
- 20 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Low-Dose Intravenous Decitabine in Patients Aged > 60 Years With Acute Myeloid Leukemia Who Are Not Eligible for Standard Induction Chemotherapy
- ClinicalTrials.gov ID
- NCT00866073
- Acronym / sponsor ID
- 00331
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, Acute myeloid leukemia, Decitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 20 Mar 2009 (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 is an open-label phase II trial to investigate the efficacy and toxicity of low-dose decitabine (5-aza-2'-deoxycytidine) in elderly patients with acute myeloid leukemia (AML) not eligible for aggressive induction chemotherapy. AML patients above the age of 60 years (no upper age limit) who have not previously received and are not eligible for, standard induction treatment of their disease will be eligible for this trial. Decitabine will be administered as a 3 hour infusion at 15 mg/m2 three times daily on three consecutive days (total dose 135 mg/m2). In all patients with > 20000 WBC/µl, this treatment will be repeated 1 week later. In patients with white blood cells exceeding 50 000/μl, decitabine treatment will be preceded by cytoreductive doses of hydroxyurea.
Detailed description
Hypothesis: If after 4 courses of Decitabine none out of 12 patients achieves a response (complete or partial remission, antileukemic effect), the protocol will be stopped. If at least one response is seen among the first 12 patients, 17 additional patients will be treated in an open, uncontrolled manner. If in 3 or more of these 29 patients a response is achieved, this treatment will be considered effective and will be studied further, otherwise it will be considered ineffective. At a preliminary analysis after recruitment of 29 patients, encouraging results (response rate, tolerability) are prompting continuation of recruitment, with a planned inclusion of at least 60 patients, until initiation of the planned large, controlled phase II follow-up trial. Unexpected toxicities will be carefully evaluated. 29 patients were needed for the first two steps of this phase II study, at least 60 patients are planned for the extension of the recruitment. Expected study duration for the first two steps was 15-20 months, with 35-40 months total when including the third step.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Decitabine 15 mg/m2 i.v.Decitabine 15 mg/m2 i.v. - single arm |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients older than 60 years with acute myeloid leukemia (> 30 % bone marrow blasts) not qualifying for, or not consenting to, standard induction chemotherapy or immediate allografting
- life expectancy > 3 months with successful treatment
- performance status ECOG 0, 1, 2
- age-adjusted normal cardiac, kidney, liver function (creatinine < 1.5 mg/dl unless leukemia-related, total bilirubin < 2.0 of upper normal limits)
- patients with >50 000 leukocytes/µl in whom initial cytoreduction according to protocol is effective
Key exclusion criteria (13 listed)
- AML of FAB subtype M3
- previous induction-type chemotherapy for MDS or AML
- previous treatment with Decitabine, 5-azacytidine or ATRA
- "low-dose" chemotherapy (e.g.hydroxyurea, cytosine arabinoside, melphalan) within 8 weeks prior to Decitabine treatment, except for cytoreduction of leukocytosis > 50 000/µl according to protocol - patients with > 50 000 leukocytes/µl in whom initial cytoreduction according to protocol is ineffective
- treatment with cytokines within previous 4 weeks
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 |
|---|---|---|
| Decitabine 15 mg/m2 i.v.Also: DacogenDecitabine at 15 mg/m2 i.v. x 3 hours, three times daily on three consecutive days | Drug | A |
Primary outcome
response rate (complete and partial remissions, antileukemic effect)
Time frame: after four treatment courses of Decitabine, after 6 months
3 secondary outcomes
overall survival
Time frame: after 1 year
progression-free survival time
Time frame: after 1 year
toxicity of Decitabine (alone and in combination with all-trans retinoic acid)
Time frame: after 3-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2009.
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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.
Michael Lübbert, Prof Dr med principal investigator
University Medical Center Freiburg - Dept. of Oncology/Hematoloy
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Decitabine 15 mg/m2 i.v. in people with Acute Myeloid Leukemia, run by University Hospital Freiburg at 8 sites in 2 countries.
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 6 inclusion and 13 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: finished, as of the sponsor's last update on 20 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Netherlands. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
response rate (complete and partial remissions, antileukemic effect) (time frame: after four treatment courses of Decitabine, after 6 months). 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 20 Mar 2009.