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Studying Genes in Samples From Younger Patients With Acute Megakaryoblastic Leukemia

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT01642069
Collaborator
National Cancer Institute (NCI) (NIH)
100
Enrollment
1
Location
46
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: laboratory biomarker analysis

Detailed Description

Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective:

Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Cryopreserved mRNA Study Population Description: Samples from AAML0531 Sampling Method: Non-Probability Sample

OBJECTIVES:

  1. To determine whether NUP98/JARID1A expression is a recurrent translocation in NUP98-rearranged cases in pediatric acute megakaryoblastic leukemia (AMKL).

  2. To screen the Children Oncology Group (COG) samples for genetic aberrations in pediatric AMKL.

OUTLINE:

Cryopreserved specimens are analyzed for NUP98 fusion to NSD1, JARID1A, and TOP1, myeloid/lymphoid or mixed-lineage leukemia (MLL)-rearrangements, and other gene expression profiling by reverse transcriptase polymerase chain reaction (RT-PCR) and karyotyping or fluorescence in situ hybridization (FISH). Results are then compared with each patient's outcome data.

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Observational - NUP98/JARID1A as a Recurrent Aberration in Pediatric Acute Megakaryoblastic Leukemia
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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
Correlative studies

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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]

  3. Overall survival (pOS, defined as time between diagnosis and death) [Up to 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Cryopreserved specimens of pediatric patients diagnosed with acute megakaryoblastic leukemia

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Oncology Group Monrovia California United States 91006-3776

Sponsors and Collaborators

  • Children's Oncology Group
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Soheil Meshinchi, MD, Children's Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01642069
Other Study ID Numbers:
  • AAML12B9
  • NCI-2012-01984
First Posted:
Jul 17, 2012
Last Update Posted:
May 18, 2016
Last Verified:
May 1, 2016
Additional relevant MeSH terms:
Leukemia
Leukemia, Megakaryoblastic, Acute

Study Results

No Results Posted as of May 18, 2016