LeukemiaNCT01407757
Study of Gemtuzumab Ozogamicin Therapy in DNA Samples From Patients With Acute Myeloid Leukemia Treated on COG-AAML0531
An observational study of Leukemia, run by Children's Oncology Group.
Trial summary
RATIONALE: DNA analysis of blood and tissue samples may help doctors predict how well patients will respond to treatment. It may also help doctors learn more about how gemtuzumab ozogamicin works in the body. Read more about this study
- Who is it for?
- Ages Up to 29 years
- Conditions the study is for
- Leukemia
- What is being tested?
- DNA analysis, gene expression analysis and laboratory biomarker analysis
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to 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 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Diagnosed with acute myeloid leukemia.
DISEASE CHARACTERISTICS:
- Diagnosed with acute myeloid leukemia
- DNA samples from patients treated on COG-AAML0531
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Pharmacogenetics of Gemtuzumab Ozogamicin (GO) Therapy in Acute Myeloid Leukemia
RATIONALE: DNA analysis of blood and tissue samples may help doctors predict how well patients will respond to treatment. It may also help doctors learn more about how gemtuzumab ozogamicin works in the body.
PURPOSE: This research study is looking at gemtuzumab ozogamicin in DNA samples from patients with acute myeloid leukemia treated on COG-AAML0531.
Read the detailed description
OBJECTIVES:
- To genotype the genomic DNA from acute myeloid leukemia (AML) patients treated on COG-AAML0531 clinical trial for CD33 (and PgP and SOC3) single nucleotide polymorphisms (SNPs).
OUTLINE: Archived DNA samples are analyzed for single nucleotide polymorphisms in CD33, PgP, and SOC3 genes by Sequenome platform. Results are then compared with patients clinical outcomes, including minimal-residual disease levels post induction I (chemotherapy and gemtuzumab ozogamicin), complete remission rates, refractory disease with various levels of bone marrow blasts, development of CNS/persistent disease, event-free survival, overall survival, and toxicity.
- Conditions
- Leukemia
- Being tested
- DNA analysis, gene expression analysis, laboratory biomarker analysis, pharmacogenomic studies
- Keywords
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with del(5q), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), untreated adult acute myeloid leukemia, untreated childhood acute myeloid leukemia and other myeloid malignancies, adult acute basophilic leukemia, childhood acute basophilic leukemia, adult acute eosinophilic leukemia, childhood acute eosinophilic leukemia, adult acute myeloblastic leukemia without maturation (M1), childhood acute myeloblastic leukemia without maturation (M1), adult acute minimally differentiated myeloid leukemia (M0), childhood acute minimally differentiated myeloid leukemia (M0), adult acute myeloblastic leukemia with maturation (M2), childhood acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), childhood acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a)
- Medical subject headings
- Leukemia, Congenital Abnormalities, Leukemia, Basophilic, Acute, Leukemia, Eosinophilic, Acute, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Acute, Leukemia, Monocytic, Acute, Leukemia, Erythroblastic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
gene expression analysisGenetic
laboratory biomarker analysisOther
pharmacogenomic studiesOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic changes in CD33 impact outcome of gemtuzumab ozogamicin-based therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 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
- NCT01407757
- Sponsor's protocol ID
- AAML11B10
- Other IDs
- COG-AAML11B10, AAML11B10, NCI-2011-03802
- Status last verified
- May 2016
- First submitted
- 30 Jul 2011
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Pollard JA, Guest E, Alonzo TA, Gerbing RB, Loken MR, Brodersen LE, Kolb EA, Aplenc R, Meshinchi S, Raimondi SC, Hirsch B, Gamis AS. Gemtuzumab Ozogamicin Improves Event-Free Survival and Reduces Relapse in Pediatric KMT2A-Rearranged AML: Results From the Phase III Children's Oncology Group Trial AAML0531. J Clin Oncol. 2021 Oct 1;39(28):3149-3160. doi: 10.1200/JCO.20.03048. Epub 2021 May 28.
PubMed 34048275Tarlock K, Alonzo TA, Wang YC, Gerbing RB, Ries R, Loken MR, Pardo L, Hylkema T, Joaquin J, Sarukkai L, Raimondi SC, Hirsch B, Sung L, Aplenc R, Bernstein I, Gamis AS, Meshinchi S, Pollard JA. Functional Properties of KIT Mutations Are Associated with Differential Clinical Outcomes and Response to Targeted Therapeutics in CBF Acute Myeloid Leukemia. Clin Cancer Res. 2019 Aug 15;25(16):5038-5048. doi: 10.1158/1078-0432.CCR-18-1897. Epub 2019 Jun 10.
PubMed 31182436Vujkovic M, Attiyeh EF, Ries RE, Goodman EK, Ding Y, Kavcic M, Alonzo TA, Wang YC, Gerbing RB, Sung L, Hirsch B, Raimondi S, Gamis AS, Meshinchi S, Aplenc R. Genomic architecture and treatment outcome in pediatric acute myeloid leukemia: a Children's Oncology Group report. Blood. 2017 Jun 8;129(23):3051-3058. doi: 10.1182/blood-2017-03-772384. Epub 2017 Apr 14.
PubMed 28411282
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetics of Gemtuzumab Ozogamicin (GO) Therapy in Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT01407757
- Acronym / sponsor ID
- AAML11B10
- Conditions
- Leukemia
- Keywords
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with del(5q), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), untreated adult acute myeloid leukemia, untreated childhood acute myeloid leukemia and other myeloid malignancies, adult acute basophilic leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2011
- Primary completion
- May 2016 (actual)
- First posted
- 2 Aug 2011 (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: DNA analysis of blood and tissue samples may help doctors predict how well patients will respond to treatment. It may also help doctors learn more about how gemtuzumab ozogamicin works in the body.
PURPOSE: This research study is looking at gemtuzumab ozogamicin in DNA samples from patients with acute myeloid leukemia treated on COG-AAML0531.
Detailed description
OBJECTIVES:
- To genotype the genomic DNA from acute myeloid leukemia (AML) patients treated on COG-AAML0531 clinical trial for CD33 (and PgP and SOC3) single nucleotide polymorphisms (SNPs).
OUTLINE: Archived DNA samples are analyzed for single nucleotide polymorphisms in CD33, PgP, and SOC3 genes by Sequenome platform. Results are then compared with patients clinical outcomes, including minimal-residual disease levels post induction I (chemotherapy and gemtuzumab ozogamicin), complete remission rates, refractory disease with various levels of bone marrow blasts, development of CNS/persistent disease, event-free survival, overall survival, and toxicity.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Diagnosed with acute myeloid 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 |
|---|---|---|
| DNA analysis | Genetic | – |
| gene expression analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| pharmacogenomic studies | Other | – |
Primary outcome
Genetic changes in CD33 impact outcome of gemtuzumab ozogamicin-based therapy
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 19 May 2016.
- Derived from this study: PubMed 34048275Pollard JA, Guest E, Alonzo TA, Gerbing RB, Loken MR, Brodersen LE, Kolb EA, Aplenc R, Meshinchi S, Raimondi SC, Hirsch B, Gamis AS. Gemtuzumab Ozogamicin Improves Event-Free Survival and Reduces Relapse in Pediatric KMT2A-Rearranged AML: Results From the Phase III Children's Oncology Group Trial AAML0531. J Clin Oncol. 2021 Oct 1;39(28):3149-3160. doi: 10.1200/JCO.20.03048. Epub 2021 May 28.
- Derived from this study: PubMed 31182436Tarlock K, Alonzo TA, Wang YC, Gerbing RB, Ries R, Loken MR, Pardo L, Hylkema T, Joaquin J, Sarukkai L, Raimondi SC, Hirsch B, Sung L, Aplenc R, Bernstein I, Gamis AS, Meshinchi S, Pollard JA. Functional Properties of KIT Mutations Are Associated with Differential Clinical Outcomes and Response to Targeted Therapeutics in CBF Acute Myeloid Leukemia. Clin Cancer Res. 2019 Aug 15;25(16):5038-5048. doi: 10.1158/1078-0432.CCR-18-1897. Epub 2019 Jun 10.
- Derived from this study: PubMed 28411282Vujkovic M, Attiyeh EF, Ries RE, Goodman EK, Ding Y, Kavcic M, Alonzo TA, Wang YC, Gerbing RB, Sung L, Hirsch B, Raimondi S, Gamis AS, Meshinchi S, Aplenc R. Genomic architecture and treatment outcome in pediatric acute myeloid leukemia: a Children's Oncology Group report. Blood. 2017 Jun 8;129(23):3051-3058. doi: 10.1182/blood-2017-03-772384. Epub 2017 Apr 14.
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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 19 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?
Genetic changes in CD33 impact outcome of gemtuzumab ozogamicin-based therapy. 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 NCT01407757, which also lists 3 linked publications.
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 19 May 2016.