Studying Genes in Samples From Younger Patients With Acute Megakaryoblastic Leukemia

Childhood Acute Megakaryocytic Leukemia (M7) Clinical Trial

Official title:

Observational - NUP98/JARID1A as a Recurrent Aberration in Pediatric Acute Megakaryoblastic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642069
• Other study ID #: AAML12B9
• Secondary ID: NCI-2012-01984
• Status: Completed
• Phase: N/A
• First received: July 15, 2012
• Last updated: May 17, 2016
• Start date: July 2012
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Years

Eligibility

Inclusion Criteria:

• Cryopreserved specimens of pediatric patients diagnosed with acute megakaryoblastic leukemia

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Childhood Acute Megakaryocytic Leukemia (M7)
• Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies
• Leukemia
• Leukemia, Megakaryoblastic, Acute
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Children's Oncology Group	Monrovia	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Overall survival (pOS, defined as time between diagnosis and death)		Up to 8 weeks	No