NCT01150656

Brief Summary

RATIONALE: Studying the effects of obatoclax mesylate in cell samples from patients with cancer in the laboratory may help doctors learn more about the effects of obatoclax mesylate on cancer cells. It may also help doctors identify biomarkers related to cancer. PURPOSE: This research study is studying obatoclax mesylate in samples from young patients with acute myeloid leukemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 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

June 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 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

5.9 years

First QC Date

June 24, 2010

Last Update Submit

May 17, 2016

Conditions

Leukemia

Keywords

childhood acute myeloid leukemia/other myeloid malignancies

Outcome Measures

Primary Outcomes (5)

  • Obatoclax mesylate activity

  • Optimum in vitro combinations of obatoclax mesylate

  • Pharmacodynamic (PD) biomarkers of activity

  • Cell death mechanism in multiple-lineage leukemia (MLL) acute myeloid leukemia (AML)

  • Disease progression in a xenograft model of MLL-rearranged infant AML

Secondary Outcomes (4)

  • Physical assessment (in xenograft model)

  • Peripheral blast count reduction

  • Apoptosis and/or ATG induction

  • Modulation of relevant PD biomarkers

Interventions

gene expression analysisGENETIC
microarray analysisGENETIC
protein expression analysisGENETIC
reverse transcriptase-polymerase chain reactionGENETIC
western blottingGENETIC
laboratory biomarker analysisOTHER
pharmacological studyOTHER

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients With Acute Myeloid Leukemia

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia (AML) * Cryopreserved samples from infants with AML available PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

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

Gene Expression ProfilingMicroarray AnalysisReverse Transcriptase Polymerase Chain ReactionBlotting, Western

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesMicrochip Analytical ProceduresPolymerase Chain ReactionNucleic Acid Amplification TechniquesElectrophoresisChemistry Techniques, AnalyticalElectrochemical TechniquesImmunoblottingImmunoassayImmunologic TechniquesMolecular Probe Techniques

Study Officials

  • Carolyn A. Felix, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 24, 2010

First Posted

June 25, 2010

Study Start

June 1, 2010

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05