NCT01139320

Brief Summary

RATIONALE: Studying samples of DNA from patients receiving gemtuzumab ozogamicin may help doctors learn more about the effects of gemtuzumab ozogamicin on cells. It may also help doctors understand how well patients respond to treatment. PURPOSE: This research study is studying biomarkers in DNA samples from younger patients with newly diagnosed with acute myeloid leukemia receiving gemtuzumab ozogamicin.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ 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

September 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 8, 2010

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

6.7 years

First QC Date

June 5, 2010

Last Update Submit

May 17, 2016

Conditions

Leukemia

Keywords

untreated childhood acute myeloid leukemia and other myeloid malignancies

Outcome Measures

Primary Outcomes (1)

  • Association between coding polymorphisms in CD33 with clinical response to gemtuzumab ozogamicin

Interventions

DNA analysisGENETIC
polymerase chain reactionGENETIC
laboratory biomarker analysisOTHER
pharmacological studyOTHER

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Newly diagnosed acute myeloid leukemia treated with gemtuzumab ozogamicin on COG-AAML03P1.

DISEASE CHARACTERISTICS: * Newly diagnosed acute myeloid leukemia * Treated with gemtuzumab ozogamicin on COG-AAML03P1 * Genomic DNA samples available 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

Leukemia

Interventions

Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification TechniquesGenetic TechniquesInvestigative Techniques

Study Officials

  • Jatinder Lamba, MD

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 5, 2010

First Posted

June 8, 2010

Study Start

September 1, 2009

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05