Acute Lymphoblastic LeukemiaPhase 2NCT00774332
A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL
A Phase 2 study testing CODOX-M in people with Acute Lymphoblastic Leukemia, run by Cooperative Study Group A for Hematology at 1 site in South Korea.
Trial summary
A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- CODOX-M
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2006to Dec 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with relapsed/resistant acute lymphoblastic leukemia
- Patients must be between 15 and 65 years of age.
- Estimated life expectancy of more than 3 months
- ECOG performance status of 2 or lower, Karnofsky scale > 60 (see appendix I)
- Adequate cardiac function (EF>45%) on echocardiogram or MUGA scan
- Adequate kidney function (estimated Ccr >50 ml/min)
Who cannot join
- Patients with CNS involvement of leukemic blasts will not be excluded.
- Patients with extramedullary relapse(s) only will be excluded.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul
Jung-Hee Lee, Doctor, 82-2-3010-5794, jhleecr@amc.seoul.kr
About this study
A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL
Read the detailed description
The feasibility will be evaluated in terms of complete remission rate, duration of complete remission, disease-free survival, overall survival, and toxicities.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- CODOX-M
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CODOX-MDrug
Cytoxan,Mesna,Adriamycin,Vincristine,Methotrexate,Leucovorin,Cytarabine
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of complete remission, disease-free survival, overall survival, toxicities
Measured: 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startJun 2006
- Primary completionJun 2006
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic 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
- Jung-Hee Lee, Doctor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774332
- Sponsor's protocol ID
- C-011
- Status last verified
- Oct 2008
- First submitted
- 15 Oct 2008
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL
- ClinicalTrials.gov ID
- NCT00774332
- Acronym / sponsor ID
- C-011
- Conditions
- Acute Lymphoblastic Leukemia
- 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
- Jun 2006
- Primary completion
- Jun 2006 (actual)
- Study completion
- Dec 2009 (estimated)
- First posted
- 17 Oct 2008 (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.
A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL
Detailed description
The feasibility will be evaluated in terms of complete remission rate, duration of complete remission, disease-free survival, overall survival, and toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with relapsed/resistant acute lymphoblastic leukemia
- Patients must be between 15 and 65 years of age.
- Estimated life expectancy of more than 3 months
- ECOG performance status of 2 or lower, Karnofsky scale > 60 (see appendix I)
- Adequate cardiac function (EF>45%) on echocardiogram or MUGA scan
Key exclusion criteria (2 listed)
- Patients with CNS involvement of leukemic blasts will not be excluded.
- Patients with extramedullary relapse(s) only will be excluded.
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 |
|---|---|---|
| CODOX-MCytoxan,Mesna,Adriamycin,Vincristine,Methotrexate,Leucovorin,Cytarabine | Drug | – |
Primary outcome
Duration of complete remission, disease-free survival, overall survival, toxicities
Time frame: 2009
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2008.
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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.
Jung-Hee Lee, Doctor principal investigator
Asan Medical Center
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 CODOX-M in people with Acute Lymphoblastic 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 17 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 Jung-Hee Lee, doctor (82-2-3010-5794, jhleecr@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of complete remission, disease-free survival, overall survival, toxicities (time frame: 2009). 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 17 Oct 2008.