Acute Myeloid LeukemiaPhase 2NCT01794169
Azacitidine Compared to Conventional Chemotherapy as Consolidation of Elderly Patients With AML
A Phase 2 study testing Azacitidine and DA in people with Acute Myeloid Leukemia, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether Azacitidine consolidation is superior to standard DA consolidation treatment of acute myeloid leukemia in first complete remission in elderly patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Azacitidine and DA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2013to Mar 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects >65 years of age at the time of signing the informed consent form
- A confirmed diagnosis of AML according to the 2008 WHO classification
- This includes: Bone marrow aspirate with a good clot or biopsy for morphology, flow cytometry, cytogenetic analysis, and in case of normal cytogenetics, molecular genetic analyses including FLT3-ITD, NPM-1 and CEBP A
- Bio-banking of leukemic cells at diagnosis performed (according to guidelines of the Swedish National AML biobank).
- A documented CR or CRp achieved after one or two induction courses.
Who cannot join
- Subjects who are not considered to be candidates to complete the consolidation therapy due to medical or psychological reasons.
- Subjects who have taken any investigational drugs or participated in an interventional clinical trial within 30 days prior to screening.
- Patients with acute promyelocytic leukemia
- Patients with t(8;21) or inv(16)
- CNS leukemia
- Patients with a previous diagnosis of MDS, i.e. AML preceded by a diagnosed MDS
- Subjects who are candidates for allogeneic stem cell transplantation (SCT)
- Another cancer diagnosis with a life expectancy of less than two years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Azacitidine Compared to Conventional Chemotherapy in Consolidation of Elderly Patients (65 Years or Older) With AML in First Complete Remission
The purpose of this study is to determine whether Azacitidine consolidation is superior to standard DA consolidation treatment of acute myeloid leukemia in first complete remission in elderly patients.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Azacitidine, DA
- 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.
AzacitidineDrug
Also called Vidaza
DADrug
Also called Daunorubicin, Cytarabine, Ara-C
| Study group | Role | What they receive |
|---|---|---|
| Azacitidine | Experimental | Azacitidine 75mg/m2/d subcutaneously once daily for 5 days given every 5:th week for 8 cycles. Receives: Drug: Azacitidine |
| DA | Active comparator | Two courses of DA in accordance with the Swedish National treatment program (reduced doses):
In case one induction course was given:
First consolidation course: daunorubicin 45 mg/m2 x 1 (iv infusion) day 1-3 and cytarabine 1000 mg/m2 x 2 (iv infusion) day 1-4.
Second consolidation course: daunorubicin 45 mg/m2 x 1( iv infusion) day 1-2 and cytarabine 200 mg x 2 (fixed dose sc injection) day 1- 5.
In case two induction courses were given:
First consolidation course: daunorubicin 45 mg/m2 x 1( iv infusion) day 1-2 and cytarabine 200 mg x 2 (fixed dose sc injection) day 1- 5.
Second consolidation course: cytarabine 200mg x 2 (fixed dose sc injection) day 1-5. Receives: Drug: DA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukemia free survival
Measured: One year
Secondary outcomes (7)
Overall survival
Measured: Two years
Treatment related morbidity and mortality
Measured: Two years
Severe Adverse Events (SAE)
SAE as defined by CTCAE
Measured: Two months after the last course of consolidation
Number of days admitted in hospital
Measured: 12 months from start of consolidation treatment
Quality of life
EORTC QLQ C30
Measured: Until 24 months from start of consolidation treatment
Number of participants with AE grade 3 or more
AE:s graded according to CTCAE
Measured: Until two months after the last course of consolidation
Number of consolidation courses actually given within the study
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2015
- Study completionMar 2018 (estimated)
Why it stopped: Poor recruitment
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.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Principal investigator, Stefan Deneberg, Karolinska University Hospital
- Investigators
- Per Bernell, M.D., Ph.D., Principal investigator, Karolinska University HospitalStefan Deneberg, M.D., Ph.D., Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794169
- Sponsor's protocol ID
- SWEAML12-a
- Status last verified
- Sep 2015
- First submitted
- 13 Feb 2013
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azacitidine Compared to Conventional Chemotherapy in Consolidation of Elderly Patients (65 Years or Older) With AML in First Complete Remission
- ClinicalTrials.gov ID
- NCT01794169
- Acronym / sponsor ID
- SWEAML12-a
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Mar 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Mar 2018 (estimated)
- First posted
- 18 Feb 2013 (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 determine whether Azacitidine consolidation is superior to standard DA consolidation treatment of acute myeloid leukemia in first complete remission in elderly patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azacitidine | Experimental | Drug: AzacitidineAzacitidine 75mg/m2/d subcutaneously once daily for 5 days given every 5:th week for 8 cycles. |
| DA | Active comparator | Drug: DATwo courses of DA in accordance with the Swedish National treatment program (reduced doses): In case one induction course was given: First consolidation course: daunorubicin 45 mg/m2 x 1 (iv infusion) day 1-3 and cytarabine 1000 mg/m2 x 2 (iv infusion) day 1-4. Second consolidation course: daunorubicin 45 mg/m2 x 1( iv infusion) day 1-2 and cytarabine 200 mg x 2 (fixed dose sc injection) day 1- 5. In case two induction courses were given: First consolidation course: daunorubicin 45 mg/m2 x 1( iv infusion) day 1-2 and cytarabine 200 mg x 2 (fixed dose sc injection) day 1- 5. Second consolidation course: cytarabine 200mg x 2 (fixed dose sc injection) day 1-5. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Subjects >65 years of age at the time of signing the informed consent form
- A confirmed diagnosis of AML according to the 2008 WHO classification
- A documented CR or CRp achieved after one or two induction courses.
Key exclusion criteria (8 listed)
- Subjects who are not considered to be candidates to complete the consolidation therapy due to medical or psychological reasons.
- Subjects who have taken any investigational drugs or participated in an interventional clinical trial within 30 days prior to screening.
- Patients with acute promyelocytic leukemia
- Patients with t(8;21) or inv(16)
- CNS 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 |
|---|---|---|
| AzacitidineAlso: Vidaza | Drug | Azacitidine |
| DAAlso: Daunorubicin, Cytarabine, Ara-C | Drug | DA |
Primary outcome
Leukemia free survival
Time frame: One year
7 secondary outcomes
Overall survival
Time frame: Two years
Treatment related morbidity and mortality
Time frame: Two years
Severe Adverse Events (SAE)
Time frame: Two months after the last course of consolidation
Number of days admitted in hospital
Time frame: 12 months from start of consolidation treatment
Quality of life
Time frame: Until 24 months from start of consolidation treatment
Number of participants with AE grade 3 or more
Time frame: Until two months after the last course of consolidation
Number of consolidation courses actually given within the study
Time frame: One year
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
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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.
Per Bernell, M.D., Ph.D. principal investigator
Karolinska University Hospital
Stefan Deneberg, M.D., Ph.D. principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azacitidine and DA in people with Acute Myeloid Leukemia, run by Karolinska University Hospital at 1 site in Sweden.
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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 22 Sep 2015. 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 Sweden. 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 was stopped early (reason given: Poor recruitment). 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?
Leukemia free survival (time frame: One year). 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 22 Sep 2015.