LeukemiaNCT01290107
Biomarkers in Samples of Bone Marrow From Patients With Acute Myeloid Leukemia
An observational study of Leukemia, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at bone marrow samples from patients with acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Leukemia
- What is being tested?
- DNA analysis, gene rearrangement analysis and microarray analysis
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Feb 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 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Diagnosis of acute myeloid leukemia.
DISEASE CHARACTERISTICS:
- Diagnosis of acute myeloid leukemia (AML)
- Cryopreserved mixed-lineage leukemia (MLL) ENL AML rearrangement cells, normal karyotype and non-MLL rearrangement AML cells, and non-leukemic bone marrow samples from the COG tissue bank
- 3 specimens of each type
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: MLL Rearrangements in Acute Myeloid Leukemia: A Pilot Project to Expand and Study MLL-ENL in NOD SCID Gamma Mice
RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at bone marrow samples from patients with acute myeloid leukemia.
Read the detailed description
OBJECTIVES:
- To successfully transplant human acute myeloid leukemia (AML) cells into immunocompromised mice for the purpose of expansion of the cells.
- To harvest the cells and use chromatin immunoprecipitation (ChIP) methods to identify the locations of the protein complexes on the genome.
- To study the interactions of the Super Elongation Complex (SEC) and Dot1 Complex (DotCom) complexes in human leukemia samples.
- To compare the genomic targets of the complexes formed by MLL-ENL chimeras to non-MLL-rearranged leukemia samples to normal controls.
OUTLINE: Cryopreserved cells are implanted into NOD SCID gamma mice, expanded, harvested, and studied by chromatin immunoprecipitation (ChIP) methods (using antibodies to ENL, Af9, and AF10). Results are then analyzed by PCR, DNA sequencing, and/or microarray analysis.
- Conditions
- Leukemia
- Being tested
- DNA analysis, gene rearrangement analysis, microarray analysis, polymerase chain reaction, immunological diagnostic method
- Keywords
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities, childhood acute myeloid leukemia/other myeloid malignancies
- Medical subject headings
- Leukemia, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
gene rearrangement analysisGenetic
microarray analysisGenetic
polymerase chain reactionGenetic
immunological diagnostic methodOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful transplantation of human acute myeloid leukemia (AML) cells into immunocompromised mice for the purpose of expansion of the cells
Secondary outcomes (2)
Identification of the locations of the protein complexes
Interactions of the SEC and DotCom complexes in human leukemia samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2015
- Study 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
- Prospective
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Eric Guest, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290107
- Sponsor's protocol ID
- AAML11B7
- Other IDs
- COG-AAML11B7, NCI-2011-02847, AAML11B7
- Status last verified
- May 2016
- First submitted
- 3 Feb 2011
- 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
- MLL Rearrangements in Acute Myeloid Leukemia: A Pilot Project to Expand and Study MLL-ENL in NOD SCID Gamma Mice
- ClinicalTrials.gov ID
- NCT01290107
- Acronym / sponsor ID
- AAML11B7
- Conditions
- Leukemia
- Keywords
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities, childhood acute myeloid leukemia/other myeloid malignancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 4 Feb 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: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at bone marrow samples from patients with acute myeloid leukemia.
Detailed description
OBJECTIVES:
- To successfully transplant human acute myeloid leukemia (AML) cells into immunocompromised mice for the purpose of expansion of the cells.
- To harvest the cells and use chromatin immunoprecipitation (ChIP) methods to identify the locations of the protein complexes on the genome.
- To study the interactions of the Super Elongation Complex (SEC) and Dot1 Complex (DotCom) complexes in human leukemia samples.
- To compare the genomic targets of the complexes formed by MLL-ENL chimeras to non-MLL-rearranged leukemia samples to normal controls.
OUTLINE: Cryopreserved cells are implanted into NOD SCID gamma mice, expanded, harvested, and studied by chromatin immunoprecipitation (ChIP) methods (using antibodies to ENL, Af9, and AF10). Results are then analyzed by PCR, DNA sequencing, and/or microarray analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Diagnosis of 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 rearrangement analysis | Genetic | – |
| microarray analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| immunological diagnostic method | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Successful transplantation of human acute myeloid leukemia (AML) cells into immunocompromised mice for the purpose of expansion of the cells
2 secondary outcomes
Identification of the locations of the protein complexes
Interactions of the SEC and DotCom complexes in human leukemia samples
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.
Related trials for Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
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.
Eric Guest, MD principal investigator
Children's Mercy Hospital Kansas City
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?
Successful transplantation of human acute myeloid leukemia (AML) cells into immunocompromised mice for the purpose of expansion of the cells. 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.