LeukemiaNCT01169363
Biomarkers in Bone Marrow and Blood Samples From Older Patients With Acute Myeloid Leukemia Treated With Cytarabine-Based Therapy
An observational study of Leukemia, run by ECOG-ACRIN Cancer Research Group.
Trial summary
RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. PURPOSE: This research study is studying biomarkers in bone marrow and blood samples from older patients with acute myeloid leukemia treated with… Read more about this study
- Who is it for?
- Ages 60 to 120 years
- Conditions the study is for
- Leukemia
- What is being tested?
- proteomic profiling, flow cytometry and laboratory biomarker analysis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 8 Jul 2010to 8 Aug 2010
- 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 60 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Samples from patients enrolled on E3999 and E3993 from whom samples were submitted for research
DISEASE CHARACTERISTICS:
- Treated on EST-1490, E-3993, or ECOG-E3999
- Bone marrow and peripheral blood samples collected at diagnosis and before induction chemotherapy available
- No M3 disease
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Validation of AML Proteomic Signature Associated With Clinical Response to Ara-C Based Induction Therapy in Patients 60 Years of Age or Older Using Samples From ECOG Studies 3999, 3993 and 1490
RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.
PURPOSE: This research study is studying biomarkers in bone marrow and blood samples from older patients with acute myeloid leukemia treated with cytarabine-based therapy.
Read the detailed description
OBJECTIVES:
Primary
- To validate a pre-specified proteomic classifier to predict the likelihood of complete response (CR) to cytarabine-based induction chemotherapy in older patients with non-M3 acute myeloid leukemia.
Secondary
- To identify signaling nodes associated with risk of relapse among these patients who achieve a CR to induction chemotherapy.
OUTLINE: This is a multicenter study.
Previously collected bone marrow and peripheral blood samples are analyzed to validate the association of a pre-specified proteomic signature with clinical response via flow cytometry.
- Conditions
- Leukemia
- Being tested
- proteomic profiling, flow cytometry, laboratory biomarker analysis
- Keywords
- adult acute myeloid leukemia in remission, recurrent adult acute myeloid leukemia, 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 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)
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Megakaryoblastic, Acute, Leukemia, Monocytic, 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.
proteomic profilingGenetic
flow cytometryOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving a complete response to induction chemotherapy
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study start8 Jul 2010
- Primary completion8 Aug 2010
- Study completion8 Aug 2010
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 ECOG-ACRIN Cancer Research 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Paietta, PhD, Principal investigator, Our Lady of Mercy Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169363
- Sponsor's protocol ID
- CDR0000681533
- Other IDs
- ECOG-E1L09T1
- Status last verified
- May 2017
- First submitted
- 23 Jul 2010
- Last updated
- 17 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of AML Proteomic Signature Associated With Clinical Response to Ara-C Based Induction Therapy in Patients 60 Years of Age or Older Using Samples From ECOG Studies 3999, 3993 and 1490
- ClinicalTrials.gov ID
- NCT01169363
- Acronym / sponsor ID
- CDR0000681533
- Conditions
- Leukemia
- Keywords
- adult acute myeloid leukemia in remission, recurrent adult acute myeloid leukemia, 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Jul 2010 (actual)
- Primary completion
- 8 Aug 2010 (actual)
- Study completion
- 8 Aug 2010 (actual)
- First posted
- 26 Jul 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 bone marrow and blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.
PURPOSE: This research study is studying biomarkers in bone marrow and blood samples from older patients with acute myeloid leukemia treated with cytarabine-based therapy.
Detailed description
OBJECTIVES:
Primary
- To validate a pre-specified proteomic classifier to predict the likelihood of complete response (CR) to cytarabine-based induction chemotherapy in older patients with non-M3 acute myeloid leukemia.
Secondary
- To identify signaling nodes associated with risk of relapse among these patients who achieve a CR to induction chemotherapy.
OUTLINE: This is a multicenter study.
Previously collected bone marrow and peripheral blood samples are analyzed to validate the association of a pre-specified proteomic signature with clinical response via flow cytometry.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Samples from patients enrolled on E3999 and E3993 from whom samples were submitted for research
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 |
|---|---|---|
| proteomic profiling | Genetic | – |
| flow cytometry | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Proportion of patients achieving a complete response to induction chemotherapy
Time frame: 1 month
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 17 May 2017.
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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.
Elisabeth Paietta, PhD principal investigator
Our Lady of Mercy Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, run by ECOG-ACRIN Cancer Research 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 17 May 2017. 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?
Proportion of patients achieving a complete response to induction chemotherapy (time frame: 1 month). 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 May 2017.