Acute Myeloid LeukemiaPhase 2NCT00559221
FLAG+Ida With G-CSF Priming for Patients Younger Than 60 Years With Resistant AML
A Phase 2 study testing FLAG+IDA in people with Acute Myeloid Leukemia, run by Cooperative Study Group A for Hematology at 1 site in South Korea.
Trial summary
To determine the feasibility of fludarabine and cytarabine as continuous infusion plus idarubicin with granulocyte-colony stimulating factor priming for patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- FLAG+IDA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2004to Jun 2008
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Failure to achieve CR after initial induction chemotherapy including standard dose cytarabine.
- Early relapse, occurring after a first CR lasting less than 12 months.
- Patients with multiple relapses will be included.
- Written informed consent must be given.
- 15 and 60 years of age.
- 2 or less by ECOG performance scale.
Who cannot join
- acute promyelocytic leukemia
- pregnant or lactating
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
Yae-Eun, Jang, 82-2-3010-7290, redpin75@paran.com
Hawk Kim, professor
About this study
Official title: Fludarabine and Cytarabine as Continuous Infusion Plus Idarubicin With Granulocyte-Colony Stimulating Factor (G-CSF) Priming for Patients Younger Than 60 Years With Resistant Acute Myeloid Leukemia
- To determine the feasibility of fludarabine and cytarabine as continuous infusion plus idarubicin with granulocyte-colony stimulating factor priming for patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia
Read the detailed description
- The feasibility will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- FLAG+IDA
- Keywords
- AML
- 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.
FLAG+IDADrug
Fludarabine, cytarabine, G-CSF
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described Receives: Drug: FLAG+IDA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate, duration of complete remission, toxicities
Measured: 06/2008
Secondary outcomes (1)
progression-free survival, overall survival
Measured: 06/2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startDec 2004
- Study completionJun 2008 (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 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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooperative Study Group A for Hematology
- Sponsor type
- Research network
- Investigators
- Hawk Kim, professor, Principal investigator, Ulsan Universtity Hospital, ROK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559221
- Sponsor's protocol ID
- C-007A
- Status last verified
- Nov 2007
- First submitted
- 15 Nov 2007
- Last updated
- 15 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim H, Lee JH, Joo YD, Bae SH, Lee JH, Kim DY, Lee WS, Ryoo HM, Jo JC, Choi Y, Lee KH; CoOperative Study Group A for Hematology (COSAH). A prospective, multicenter phase II study of continuous infusion of FLAG for patients older than 60 yr with resistant acute myeloid leukemia: a comparison with intensive younger patients' trial. Eur J Haematol. 2016 Feb;96(2):188-97. doi: 10.1111/ejh.12568. Epub 2015 May 6.
PubMed 25891993
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fludarabine and Cytarabine as Continuous Infusion Plus Idarubicin With Granulocyte-Colony Stimulating Factor (G-CSF) Priming for Patients Younger Than 60 Years With Resistant Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00559221
- Acronym / sponsor ID
- C-007A
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Cooperative Study Group A for HematologyResearch network
- Study start
- Dec 2004
- Study completion
- Jun 2008 (estimated)
- First posted
- 16 Nov 2007 (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.
- To determine the feasibility of fludarabine and cytarabine as continuous infusion plus idarubicin with granulocyte-colony stimulating factor priming for patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia
Detailed description
- The feasibility will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | Drug: FLAG+IDA |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Failure to achieve CR after initial induction chemotherapy including standard dose cytarabine.
- Early relapse, occurring after a first CR lasting less than 12 months.
- Patients with multiple relapses will be included.
- Written informed consent must be given.
- 15 and 60 years of age.
Key exclusion criteria (2 listed)
- acute promyelocytic leukemia
- pregnant or lactating
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 |
|---|---|---|
| FLAG+IDAFludarabine, cytarabine, G-CSF | Drug | 1 |
Primary outcome
Complete remission rate, duration of complete remission, toxicities
Time frame: 06/2008
1 secondary outcome
progression-free survival, overall survival
Time frame: 06/2008
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2008.
- Derived from this study: PubMed 25891993Kim H, Lee JH, Joo YD, Bae SH, Lee JH, Kim DY, Lee WS, Ryoo HM, Jo JC, Choi Y, Lee KH; CoOperative Study Group A for Hematology (COSAH). A prospective, multicenter phase II study of continuous infusion of FLAG for patients older than 60 yr with resistant acute myeloid leukemia: a comparison with intensive younger patients' trial. Eur J Haematol. 2016 Feb;96(2):188-97. doi: 10.1111/ejh.12568. Epub 2015 May 6.
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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.
Hawk Kim, professor principal investigator
Ulsan Universtity Hospital, ROK
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 FLAG+IDA in people with Acute Myeloid Leukemia, run by Cooperative Study Group A for Hematology at 1 site in South Korea.
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 2 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 15 Oct 2008. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yae-Eun Jang, nurse (80-2-3010-7290, redpin75@paran.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate, duration of complete remission, toxicities (time frame: 06/2008). 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 NCT00559221, 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 15 Oct 2008.