Studying Genes in Samples From Younger Patients With Acute Megakaryoblastic Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01642069
First received: July 15, 2012
Last updated: May 5, 2015
Last verified: May 2015

July 15, 2012
May 5, 2015
July 2012
January 2100   (final data collection date for primary outcome measure)
  • 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) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Probability of event-free survival (pEFS, defined as time between diagnosis and first event, including non-remitting, death of any cause and second malignancy) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Overall survival (pOS, defined as time between diagnosis and death) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
NUP98/JARID1A as a recurrent aberration in pediatric AMKL [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01642069 on ClinicalTrials.gov Archive Site
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Studying Genes in Samples From Younger Patients With Acute Megakaryoblastic Leukemia
Observational - NUP98/JARID1A as a Recurrent Aberration in Pediatric Acute Megakaryoblastic Leukemia

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

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:

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

II. 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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Patients diagnosed with acute megakaryoblastic leukemia.

  • Childhood Acute Megakaryocytic Leukemia (M7)
  • Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies
Other: laboratory biomarker analysis
Correlative studies
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.
Intervention: Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
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January 2100   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Cryopreserved specimens of pediatric patients diagnosed with acute megakaryoblastic leukemia
Both
up to 30 Years
No
United States
 
NCT01642069
AAML12B9, NCI-2012-01984
No
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Soheil Meshinchi, MD Children's Oncology Group
Children's Oncology Group
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP