NCT01169363

Brief 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 cytarabine-based therapy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2010

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1 month

First QC Date

July 23, 2010

Last Update Submit

May 16, 2017

Conditions

Keywords

adult acute myeloid leukemia in remissionrecurrent adult acute myeloid leukemiaadult 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) abnormalitiesadult 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)

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients achieving a complete response to induction chemotherapy

    1 month

Interventions

Eligibility Criteria

Age60 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, AcuteLeukemia, Erythroblastic, AcuteLeukemia, Megakaryoblastic, AcuteLeukemia, Monocytic, AcuteLeukemia, Myelomonocytic, AcuteCongenital Abnormalities

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Elisabeth Paietta, PhD

    Our Lady of Mercy Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2010

First Posted

July 26, 2010

Study Start

July 8, 2010

Primary Completion

August 8, 2010

Study Completion

August 8, 2010

Last Updated

May 17, 2017

Record last verified: 2017-05