NCT01642069

Brief Summary

This laboratory study is looking into genes in samples from younger patients with acute megakaryoblastic leukemia (AMKL). Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in RNA and identify biomarkers related to cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

3.8 years

First QC Date

July 15, 2012

Last Update Submit

May 17, 2016

Conditions

Childhood Acute Megakaryocytic Leukemia (M7)Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies

Outcome Measures

Primary Outcomes (3)

  • Complete remission (CR, defined as less than 5% blasts in the bone marrow, with regeneration of tri-lineage hematopoiesis, plus absence of leukemic cells in the cerebrospinal fluid or elsewhere)

    Up to 8 weeks

  • Probability of event-free survival (pEFS, defined as time between diagnosis and first event, including non-remitting, death of any cause and second malignancy)

    Up to 8 weeks

  • Overall survival (pOS, defined as time between diagnosis and death)

    Up to 8 weeks

Study Arms (1)

Observational

Cryopreserved specimens are analyzed for NUP98 fusion to NSD1, JARID1A, and TOP1, myeloid/lymphoid or MLL-rearrangements, and other gene expression profiling by RT-PCR and karyotyping or FISH. Results are then compared with each patient's outcome data.

Other: laboratory biomarker analysis

Interventions

laboratory biomarker analysisOTHER

Correlative studies

Observational

Eligibility Criteria

AgeUp to 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with acute megakaryoblastic leukemia.

You may qualify if:

  • Cryopreserved specimens of pediatric patients diagnosed with acute megakaryoblastic leukemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Monrovia, California, 91006-3776, United States

Location

Study Officials

  • Soheil Meshinchi, MD

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 15, 2012

First Posted

July 17, 2012

Study Start

July 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05

Locations

US(1)