LeukemiaNCT01139320
Biomarkers in DNA Samples From Younger Patients With Newly Diagnosed Acute Myeloid Leukemia Receiving Gemtuzumab Ozogamicin
An observational study of Leukemia, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of DNA from patients receiving gemtuzumab ozogamicin may help doctors learn more about the effects of gemtuzumab ozogamicin on cells. It may also help doctors understand how well patients respond to treatment. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Leukemia
- What is being tested?
- DNA analysis, polymerase chain reaction and laboratory biomarker analysis
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to May 2016
- Phase
- Observational
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Newly diagnosed acute myeloid leukemia treated with gemtuzumab ozogamicin on COG-AAML03P1.
DISEASE CHARACTERISTICS:
- Newly diagnosed acute myeloid leukemia
- Treated with gemtuzumab ozogamicin on COG-AAML03P1
- Genomic DNA samples available
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Pharmacogenetics of Mylotarg
RATIONALE: Studying samples of DNA from patients receiving gemtuzumab ozogamicin may help doctors learn more about the effects of gemtuzumab ozogamicin on cells. It may also help doctors understand how well patients respond to treatment.
PURPOSE: This research study is studying biomarkers in DNA samples from younger patients with newly diagnosed with acute myeloid leukemia receiving gemtuzumab ozogamicin.
Read the detailed description
OBJECTIVES:
- To analyze candidate-coding polymorphisms in CD33 of DNA samples from children with newly diagnosed acute myeloid leukemia treated with gemtuzumab ozogamicin on COG-AAML03P1.
- To determine the association between these polymorphisms and clinical response of patients treated with this regimen.
OUTLINE: Archived DNA samples are analyzed for candidate polymorphisms in CD33 by PCR-based sequencing.
- Conditions
- Leukemia
- Being tested
- DNA analysis, polymerase chain reaction, laboratory biomarker analysis, pharmacological study
- Keywords
- untreated childhood acute myeloid leukemia and other myeloid malignancies
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
polymerase chain reactionGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between coding polymorphisms in CD33 with clinical response to gemtuzumab ozogamicin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startSep 2009
- Primary completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jatinder Lamba, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139320
- Sponsor's protocol ID
- AAML10B3
- Other IDs
- COG-AAML10B3, CDR0000671448, NCI-2011-02220
- Status last verified
- May 2016
- First submitted
- 5 Jun 2010
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetics of Mylotarg
- ClinicalTrials.gov ID
- NCT01139320
- Acronym / sponsor ID
- AAML10B3
- Conditions
- Leukemia
- Keywords
- untreated childhood acute myeloid leukemia and other myeloid malignancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2009
- Primary completion
- May 2016 (actual)
- First posted
- 8 Jun 2010 (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.
RATIONALE: Studying samples of DNA from patients receiving gemtuzumab ozogamicin may help doctors learn more about the effects of gemtuzumab ozogamicin on cells. It may also help doctors understand how well patients respond to treatment.
PURPOSE: This research study is studying biomarkers in DNA samples from younger patients with newly diagnosed with acute myeloid leukemia receiving gemtuzumab ozogamicin.
Detailed description
OBJECTIVES:
- To analyze candidate-coding polymorphisms in CD33 of DNA samples from children with newly diagnosed acute myeloid leukemia treated with gemtuzumab ozogamicin on COG-AAML03P1.
- To determine the association between these polymorphisms and clinical response of patients treated with this regimen.
OUTLINE: Archived DNA samples are analyzed for candidate polymorphisms in CD33 by PCR-based sequencing.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Newly diagnosed acute myeloid leukemia treated with gemtuzumab ozogamicin on COG-AAML03P1.
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 |
|---|---|---|
| DNA analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| laboratory biomarker analysis | Other | – |
| pharmacological study | Other | – |
Primary outcome
Association between coding polymorphisms in CD33 with clinical response to gemtuzumab ozogamicin
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 18 May 2016.
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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.
Jatinder Lamba, MD principal investigator
Masonic Cancer Center, University of Minnesota
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, run by Children's Oncology Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Association between coding polymorphisms in CD33 with clinical response to gemtuzumab ozogamicin. 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 18 May 2016.