Acute Myeloid LeukemiaPhase 2NCT00529880
Fludarabine and Cytarabine as Continuous Infusion Plus G-CSF Priming for Elderly Patients With Resistant AML
A Phase 2 study testing Fludarabine , cytarabine 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 granulocyte-colony stimulating factor priming for elderly patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia The feasibility will be evaluated in terms of toxicities, complete remission rate… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Fludarabine , cytarabine
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2004to Oct 2007
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Failure to achieve CR after initial induction chemotherapy
- Any relapse, regardless of the frequency and time of relapse from first CR
- Relapse after hematopoietic cell transplantation, allogeneic or autologous.
- Multiple relapses, extramedullary relapse(s)
Who cannot join
- Inadequate hepatic,renal,cardiac function
- Psychiatric disorder or mental deficiency
- CNS involvement of leukemic blasts
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Songpa-gu, Seoul, 138-833
Keun-Hee Kim, nurse, 82-2-3010-7290, kuny9847@naver.com
About this study
- To determine the feasibility of fludarabine and cytarabine as continuous infusion plus granulocyte-colony stimulating factor priming for elderly patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia
- The feasibility will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.
Read the detailed description
- A second course of induction chemotherapy can be given to the patient when a partial remission but less than a complete remission is achieved after the first course. At least 4 weeks should be apart between start of the first course and start of the second course.
- G-CSF (Lenograstim) 250 g/day will begin to be administered after the confirmation of hypocellular bone marrow with blasts less than 5% on day 14 or later until absolute neutrophil counts are 1,000/l or more.
- For the patients who achieve a complete remission, consolidation therapy will be given as follows:
- Two more cycles of the same chemotherapy will be given to the patients who achieve a complete remission after single induction course. Allogeneic or autologous hematopoietic cell transplantation could be also considered.
- In patients who relapse after allogeneic hematopoietic cell transplantation, donor leukocyte infusion will be done without consolidation chemotherapy.
- In patients who had extramedullary relapse(s), local radiotherapy can be given to the relapse site(s).
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Fludarabine , cytarabine
- 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.
Fludarabine , cytarabineDrug
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
Secondary outcomes (1)
progression-free survival, overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startDec 2004
- Study completionOct 2007 (estimated)
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
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooperative Study Group A for Hematology
- Sponsor type
- Research network
- Investigators
- Hawk Kim, professor, Principal investigator, Ulsan University Hospital, ROK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529880
- Sponsor's protocol ID
- C-008
- Status last verified
- Sep 2007
- First submitted
- 12 Sep 2007
- Last updated
- 27 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fludarabine and Cytarabine as Continuous Infusion Plus G-CSF Priming for Elderly Patients With Resistant AML
- ClinicalTrials.gov ID
- NCT00529880
- Acronym / sponsor ID
- C-008
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Cooperative Study Group A for HematologyResearch network
- Study start
- Dec 2004
- Study completion
- Oct 2007 (estimated)
- First posted
- 14 Sep 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 granulocyte-colony stimulating factor priming for elderly patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia
- The feasibility will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.
Detailed description
- A second course of induction chemotherapy can be given to the patient when a partial remission but less than a complete remission is achieved after the first course. At least 4 weeks should be apart between start of the first course and start of the second course.
- G-CSF (Lenograstim) 250 g/day will begin to be administered after the confirmation of hypocellular bone marrow with blasts less than 5% on day 14 or later until absolute neutrophil counts are 1,000/l or more.
- For the patients who achieve a complete remission, consolidation therapy will be given as follows:
- Two more cycles of the same chemotherapy will be given to the patients who achieve a complete remission after single induction course. Allogeneic or autologous hematopoietic cell transplantation could be also considered.
- In patients who relapse after allogeneic hematopoietic cell transplantation, donor leukocyte infusion will be done without consolidation chemotherapy.
- In patients who had extramedullary relapse(s), local radiotherapy can be given to the relapse site(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Failure to achieve CR after initial induction chemotherapy
- Any relapse, regardless of the frequency and time of relapse from first CR
- Relapse after hematopoietic cell transplantation, allogeneic or autologous.
- Multiple relapses, extramedullary relapse(s)
Key exclusion criteria (3 listed)
- Inadequate hepatic,renal,cardiac function
- Psychiatric disorder or mental deficiency
- CNS involvement of leukemic blasts
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 |
|---|---|---|
| Fludarabine , cytarabine | Drug | – |
Primary outcome
Complete remission rate, duration of complete remission, toxicities
1 secondary outcome
progression-free survival, overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2007.
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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 University 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 Fludarabine , cytarabine 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 4 inclusion and 3 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 27 Sep 2007. 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 Keun-Hee Kim, nurse (82-2-3010-7290, kuny9847@naver.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. 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 27 Sep 2007.