Acute Myeloid LeukemiaPhase 2/3MYFLAI07NCT00909168
Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)
A Phase 2/3 study testing FLAIMy - Fluda, Ida, Ara-C, Mylotarg in people with Acute Myeloid Leukemia, run by University Hospital, Udine, Italy at 1 site in Italy.
Trial summary
This is a prospective, open, non-randomized, non-controlled, phase II, clinical trial for treatment of newly diagnosed AML patients, younger than 66 years. Trial is based on: INDUCTION: FLAI + Gemtuzumab-Ozogamicin (FLAI-GO). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- FLAIMy - Fluda, Ida, Ara-C, Mylotarg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2008to Mar 2013
- Phase
- Phase 2/3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years.
- WHO PS grade 0-2 (Appendix B) or Karnofsky > 70.
- AML according to the new WHO criteria, i.e., % of BM blasts ≥ 20%. NB. this % should be assessed on a BM aspiration or on a BM biopsy
- All FAB subtypes except M3.
- CD33 positivity (> 20%). It is mandatory to perform an immunotyping of the BM blasts in particular the determination of CD33 positivity, which will be used as a inclusion factor.
- Previously untreated (except ≤ 14 days of Hydroxyurea) primary or secondary AML (including AML after MDS).
- Adequate renal and liver function, i.e., creatinine < 2 mg/dl and bilirubin, ALT/AST ≤ 3 times the upper limit of normal.
- Written informed consent
Who cannot join
- Blast crisis of chronic myeloid leukemia.
- AML supervening after other myeloproliferative diseases.
- AML de novo or secondary previously pretreated.
- Concomitant malignant disease.
- Active central nervous system (CNS) leukemia.
- Active uncontrolled infection [NB severe systemic infection should be excluded].
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- Concomitant severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease.
- Cardiac ejection fraction of 50% or less.
- Severe pulmonary dysfunction (CTC grade 3-4).
- Severe concomitant neurological or psychiatric disease.
- History of alcohol abuse.
- HIV positivity.
- Pregnancy.
- Man and woman not agreeing to the adequate contraceptive precautions during study period and for at last 24 months after stop of therapy.
- Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, open, non-randomized, non-controlled, phase II, clinical trial for treatment of newly diagnosed AML patients, younger than 66 years.
Trial is based on:
Read more
- INDUCTION: FLAI + Gemtuzumab-Ozogamicin (FLAI-GO).
- CONSOLIDATION: Intermediate dose AraC + IDA (IDAC+IDA) +/- one course of high dose AraC (HDAC)
- INTENSIFICATION: Allo-BMT, ASCT
- MAINTENANCE: AraC
- Primary endpoints:
- Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.
- RFS, DFS and OS.
- Secondary endpoints:
- Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring.
- Evaluation of prognostic clinical relevance of biological features at onset.
- Feasibility and outcome of consolidation with BMT.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- FLAIMy - Fluda, Ida, Ara-C, Mylotarg
- Keywords
- Induction chemotherapy, Fludarabine, Gemtuzumab Ozogamicin
- 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.
FLAIMy - Fluda, Ida, Ara-C, MylotargDrug
FLUDARABINE: 25 mg/m2/day, 250 FS in 30', start h 9 - 1, 2, 3, 4, 5
ARABINOSYL-CYTOSINE (Cytarabine): 2 g/m2/day, 500 FS in 3 h, start h 13 - 1, 2, 3, 4, 5
IDARUBICIN: 10 mg/m2/day, 100 FS in 1 h, start h 16 - 1, 3, 5
GEMTUZUMAB OZOGAMICIN (Mylotarg): 5 mg, single dose 500 FS in 4 h - 6
| Study group | Role | What they receive |
|---|---|---|
| Efficacy of FLAIMy | Experimental | Not described Receives: Drug: FLAIMy - Fluda, Ida, Ara-C, Mylotarg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.
Measured: one year
RFS, DFS and OS.
Measured: one year
Secondary outcomes (3)
Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring.
Measured: one year
Evaluation of prognostic clinical relevance of biological features at onset.
Measured: one year
Feasibility and outcome of consolidation with BMT.
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 posted27 May 2009 (estimated)
- Study startMar 2008
- Primary completionMay 2009
- Study completionMar 2013
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 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Udine, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CANDONI ANNA, University Hospital, Udine, Italy
- Investigators
- ANNA CANDONI, MD, Study director, UUNIVERSITY HOSPITAL, UDINE, ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909168
- Sponsor's protocol ID
- MYFLAI07
- Acronym
- MYFLAI07
- Status last verified
- May 2014
- First submitted
- 26 May 2009
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Candoni A, Papayannidis C, Martinelli G, Simeone E, Gottardi M, Iacobucci I, Gherlinzoni F, Visani G, Baccarani M, Fanin R. Flai (fludarabine, cytarabine, idarubicin) plus low-dose Gemtuzumab Ozogamicin as induction therapy in CD33-positive AML: Final results and long term outcome of a phase II multicenter clinical trial. Am J Hematol. 2018 May;93(5):655-663. doi: 10.1002/ajh.25057. Epub 2018 Mar 2.
PubMed 29396857
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT00909168
- Acronym / sponsor ID
- MYFLAI07 / MYFLAI07
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Induction chemotherapy, Fludarabine, Gemtuzumab Ozogamicin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital, Udine, ItalyUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 27 May 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 is a prospective, open, non-randomized, non-controlled, phase II, clinical trial for treatment of newly diagnosed AML patients, younger than 66 years.
Trial is based on:
- INDUCTION: FLAI + Gemtuzumab-Ozogamicin (FLAI-GO).
- CONSOLIDATION: Intermediate dose AraC + IDA (IDAC+IDA) +/- one course of high dose AraC (HDAC)
- INTENSIFICATION: Allo-BMT, ASCT
- MAINTENANCE: AraC
- Primary endpoints:
- Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.
- RFS, DFS and OS.
- Secondary endpoints:
- Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring.
- Evaluation of prognostic clinical relevance of biological features at onset.
- Feasibility and outcome of consolidation with BMT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Efficacy of FLAIMy | Experimental | Drug: FLAIMy - Fluda, Ida, Ara-C, Mylotarg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-65 years.
- WHO PS grade 0-2 (Appendix B) or Karnofsky > 70.
- AML according to the new WHO criteria, i.e., % of BM blasts ≥ 20%. NB. this % should be assessed on a BM aspiration or on a BM biopsy
- All FAB subtypes except M3.
- CD33 positivity (> 20%). It is mandatory to perform an immunotyping of the BM blasts in particular the determination of CD33 positivity, which will be used as a inclusion factor.
Key exclusion criteria (15 listed)
- Blast crisis of chronic myeloid leukemia.
- AML supervening after other myeloproliferative diseases.
- AML de novo or secondary previously pretreated.
- Concomitant malignant disease.
- Active central nervous system (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 |
|---|---|---|
| FLAIMy - Fluda, Ida, Ara-C, MylotargFLUDARABINE: 25 mg/m2/day, 250 FS in 30', start h 9 - 1, 2, 3, 4, 5 ARABINOSYL-CYTOSINE (Cytarabine): 2 g/m2/day, 500 FS in 3 h, start h 13 - 1, 2, 3, 4, 5 IDARUBICIN: 10 mg/m2/day, 100 FS in 1 h, start h 16 - 1, 3, 5 GEMTUZUMAB OZOGAMICIN (Mylotarg): 5 mg, single dose 500 FS in 4 h - 6 | Drug | Efficacy of FLAIMy |
Primary outcome
Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.
Time frame: one year
RFS, DFS and OS.
Time frame: one year
3 secondary outcomes
Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring.
Time frame: one year
Evaluation of prognostic clinical relevance of biological features at onset.
Time frame: one year
Feasibility and outcome of consolidation with BMT.
Time frame: one year
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 6 May 2014.
- Derived from this study: PubMed 29396857Candoni A, Papayannidis C, Martinelli G, Simeone E, Gottardi M, Iacobucci I, Gherlinzoni F, Visani G, Baccarani M, Fanin R. Flai (fludarabine, cytarabine, idarubicin) plus low-dose Gemtuzumab Ozogamicin as induction therapy in CD33-positive AML: Final results and long term outcome of a phase II multicenter clinical trial. Am J Hematol. 2018 May;93(5):655-663. doi: 10.1002/ajh.25057. Epub 2018 Mar 2.
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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.
ANNA CANDONI, MD study director
UUNIVERSITY HOSPITAL, UDINE, ITALY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing FLAIMy - Fluda, Ida, Ara-C, Mylotarg in people with Acute Myeloid Leukemia, run by University Hospital, Udine, Italy at 1 site in Italy.
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 15 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 6 May 2014. 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 Italy. 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 combined 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.
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?
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?
Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin. (time frame: one year). 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?
On the ClinicalTrials.gov record for NCT00909168, 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 May 2014.