LeukemiaNCT00899743
S9333A Study of Blood and Bone Marrow Samples From Patients With Previously Untreated Primary Acute Myeloid Leukemia
An observational study of Leukemia, run by SWOG Cancer Research Network.
Trial summary
RATIONALE: Studying samples of blood and 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. Read more about this study
- Who is it for?
- Ages 56 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- polyacrylamide gel electrophoresis, western blotting and immunologic technique
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Jun 2009
- 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 56 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: specimens from S9333
DISEASE CHARACTERISTICS:
- Cryopreserved specimens of marrow or peripheral blood from patients enrolled in clinical trial SWOG-9333 and meeting the following criteria:
- Diagnosis of primary acute myeloid leukemia
- No M3 disease
- Previously untreated disease
- Randomized to remission induction chemotherapy with mitoxantrone hydrochloride and etoposide (Arm II)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Determining the Clinicopathological Significance of CaMKIIgamma Activation in AML
RATIONALE: Studying samples of blood and 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 blood and bone marrow samples from patients with previously untreated primary acute myeloid leukemia.
Read the detailed description
OBJECTIVES:
- Determine whether calmodulin-dependent protein kinase II-γ (CaMKIIγ) activation (autophosphorylation) is associated with specific clinicopathological variables and outcomes in blood and bone marrow samples from patients with previously untreated primary acute myeloid leukemia.
OUTLINE: Blood and bone marrow samples are analyzed by western blot using SDS-PAGE and immunoblotting using anti-calmodulin-dependent protein kinase II-γ (CaMKIIγ) and anti-phosphospecific (Thr286, 287) CaMKIIγ antibodies with signals detected via chemiluminescence. CaMKIIγ activation levels are linked to clinical variables within the SWOG database.
- Conditions
- Leukemia
- Being tested
- polyacrylamide gel electrophoresis, western blotting, immunologic technique, laboratory biomarker analysis
- Keywords
- adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, untreated adult acute myeloid leukemia
- Medical subject headings
- Leukemia, Leukemia, Erythroblastic, Acute, Leukemia, Megakaryoblastic, Acute, Leukemia, Monocytic, Acute, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Acute, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyacrylamide gel electrophoresisGenetic
polyacrylamide gel electrophoresis
western blottingGenetic
western blotting
immunologic techniqueOther
immunologic technique
laboratory biomarker analysisOther
laboratory biomarker analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of specific clinicopathological variables and outcomes with calmodulin-dependent protein kinase II-γ (CaMKIIγ) activation (autophosphorylation)
Measured: upon receipt of specimens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startAug 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe 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
- Time perspective
- Retrospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Steven J. Collins, MD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899743
- Sponsor's protocol ID
- S9333A
- Other IDs
- U10CA032102, SWOG-9333A
- Status last verified
- Mar 2015
- First submitted
- 9 May 2009
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Medeiros BC, Othus M, Fang M, Appelbaum FR, Erba HP. Cytogenetic heterogeneity negatively impacts outcomes in patients with acute myeloid leukemia. Haematologica. 2015 Mar;100(3):331-5. doi: 10.3324/haematol.2014.117267. Epub 2014 Dec 19.
PubMed 25527568Medeiros BC, Othus M, Estey EH, Fang M, Appelbaum FR. Unsuccessful diagnostic cytogenetic analysis is a poor prognostic feature in acute myeloid leukaemia. Br J Haematol. 2014 Jan;164(2):245-50. doi: 10.1111/bjh.12625. Epub 2013 Oct 28.
PubMed 24383844
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Clinicopathological Significance of CaMKIIgamma Activation in AML
- ClinicalTrials.gov ID
- NCT00899743
- Acronym / sponsor ID
- S9333A
- Conditions
- Leukemia
- Keywords
- adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 12 May 2009 (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 blood and 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 blood and bone marrow samples from patients with previously untreated primary acute myeloid leukemia.
Detailed description
OBJECTIVES:
- Determine whether calmodulin-dependent protein kinase II-γ (CaMKIIγ) activation (autophosphorylation) is associated with specific clinicopathological variables and outcomes in blood and bone marrow samples from patients with previously untreated primary acute myeloid leukemia.
OUTLINE: Blood and bone marrow samples are analyzed by western blot using SDS-PAGE and immunoblotting using anti-calmodulin-dependent protein kinase II-γ (CaMKIIγ) and anti-phosphospecific (Thr286, 287) CaMKIIγ antibodies with signals detected via chemiluminescence. CaMKIIγ activation levels are linked to clinical variables within the SWOG database.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 56 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- specimens from S9333
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 |
|---|---|---|
| polyacrylamide gel electrophoresispolyacrylamide gel electrophoresis | Genetic | – |
| western blottingwestern blotting | Genetic | – |
| immunologic techniqueimmunologic technique | Other | – |
| laboratory biomarker analysislaboratory biomarker analysis | Other | – |
Primary outcome
Association of specific clinicopathological variables and outcomes with calmodulin-dependent protein kinase II-γ (CaMKIIγ) activation (autophosphorylation)
Time frame: upon receipt of specimens
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 6 Mar 2015.
- Derived from this study: PubMed 25527568Medeiros BC, Othus M, Fang M, Appelbaum FR, Erba HP. Cytogenetic heterogeneity negatively impacts outcomes in patients with acute myeloid leukemia. Haematologica. 2015 Mar;100(3):331-5. doi: 10.3324/haematol.2014.117267. Epub 2014 Dec 19.
- Derived from this study: PubMed 24383844Medeiros BC, Othus M, Estey EH, Fang M, Appelbaum FR. Unsuccessful diagnostic cytogenetic analysis is a poor prognostic feature in acute myeloid leukaemia. Br J Haematol. 2014 Jan;164(2):245-50. doi: 10.1111/bjh.12625. Epub 2013 Oct 28.
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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.
Steven J. Collins, MD principal investigator
Fred Hutchinson Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, run by SWOG Cancer Research Network.
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 6 Mar 2015. 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 of specific clinicopathological variables and outcomes with calmodulin-dependent protein kinase II-γ (CaMKIIγ) activation (autophosphorylation) (time frame: upon receipt of specimens). 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 NCT00899743, which also lists 2 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 6 Mar 2015.